The Amgen Chronicles

I have been in the business long enough to remember when Amgen was the largest and most successful biotechnology company in the world. During most of the 90s and early 2000s, Amgen was second to none. But, a lack of innovation, questionable marketing practices and an uncreative executive management team forced the once invincible biotech Giant to recently stumble and relinquish its world class status

For those of you who may not be familiar with Amgen, it was founded in 1980 by a team of scientists led by George B. Rathmann. The company’s original name was Applied Molecular Genetics which was officially changed in 1983 to Amgen. Its first product, Epogen (EPO; epoetin-alfa) an erythropoiesis-stimulating hormone was approved in 1989 when Gordon Binder was CEO. 

EPO quickly became the company’s flagship blockbuster product and was largely responsible for Amgen’s early success.  The company’s second blockbuster product Neupogen (Filgrastim) a recombinant-methionyl human granulocyte colony factor (G-CSF)—also under Binder’s leadership—which stimulates neutrophil (white blood cell) production was approved in 1998. In the early 2000s the company—now under the tutelage of its third CEO, Kevin Shearer—introduced a longer acting, second generation EPO product called Aranesp (darbepoetin-alfa) and Neulasta (pegfilgrastim), a second generation, longer-acting PEGylated version of recombinant G-CSF.

The largesse from the EPO and Filgrastim franchises allowed Amgen to rapidly expand in the 2000s and to heavily invest substantial resources into new drug development (both small molecule and biotechnology). Unfortunately, most of these investments did not pan out; with the possible exception of XGEVA (denosumab) and Prolia (denosumab) a monoclonal antibody (MAb) treatment that recently received approval for the treatment of skeletal-related events including pathological faction in patients with bone metastases from solid tumors and postmenopausal osteoporosis respectively.

In the 2000s, Amgen’s went on something of a “buying spree” during Mr Shearer’s 11 year tenure at the company. During this time Amgen acquired eight companies including three high profiles and well known ones; Immunex (2002) a MAb development company; Tularik (2004) a small molecule discovery company and Abgenix (2006) another MAb development entity. The Immunex acquisition, clearly the most profitable one, gave Amgen access to Enbrel (etanercept) a tumor necrosis factor α MAb indicated for the treatment of various forms of arthritis. Enbrel is currently one of the world’s top selling biotechnology products.

Despite its lack of R&D productivity, Amgen was recognized until recently as the world’s largest and most profitable biotechnology company in the world. However, its lack of R& D productivity coupled with a recent, highly publicized regulatory and criminal inquiry into inappropriate marketing associated with its EPO franchise has seriously tarnished the company’s once impeccable reputation. Interestingly, it appears that Amgen is finally attempting to reinvent itself.

Last week, the company announced that its CEO, Kevin Shearer and Dr. Roger M. Perlmutter, head of R&D will retire early next year. Mr. Shearer will be succeeded by Robert Bradway, a former Wall Street executive who is Amgen’s current chief operating officer. Dr. Perlmutter will be replaced by Sean Harper, MD, the company’s chief medical officer. And, last month, Amgen announced that it plans on buying back up to $5 billion shares of its publicly-held stock in an attempt to return profit to shareholders. Finally, today, the company announced that it entered into a deal with Watson Pharmaceuticals, a leading generics company, to develop biosimilar versions of some of its competitor’s blockbuster cancer-fighting biotechnology drugs. The press release made it clear that the deal did not include developing biosimilar versions of any of Amgen’s currently marketed biotechnology products. Nevertheless, today’s announcement strongly suggests that Amgen is willing to use anything at its disposal (in this case its substantial expertise in biomanufacturing rather than new drug development) to generate additional revenue streams for the company.

The recent organizational changes and strategic decisions made by Amgen’s board of directors and management team tends to validate the need for change at the company so that it can remain profitable and possibly restore its reputation as a global biotechnology leader. That said, like most other things in life, only time can tell!

Until next time...

Good Luck and Good Job Hunting!!!!!!!

 

Boehringer Ingelheim Announces Plans to Bolster Its Manufacturing Capability in China

The German pharmaceutical company Boehringer Ingelheim (BI) today announced that it plans on investing 70 million Euros to expand its manufacturing facility in the Zhangijiang High-Tech Park in Shanghai China. The expansion will continue through 2013 and the number of employees will increase from 240 to 400 at the new facility

BI was one of the first pharmaceutical companies to enter China in 1994 and the planned expansion was proposed to solidify the company’s position in the emerging Chinese market. The expansion will be modular and based on lean manufacturing practices to provide world class manufacturing capability at the site.   The company already sells certain therapeutic products in China including respiratory, cardiovascular, and CNS. Expansion of the existing manufacturing facility is intended to allow BI to expand into other therapeutic areas that include diabetes, oncology and stroke prevention.

Late last week Merck announced plans to build a new R&D facility in Beijing. Other companies have also announced plans to increase their presence in the Chinese market. I think it may be the time for American student to begin to consider Mandarin as their foreign language in primary and second school education programs.

Until next time...

Good Luck and Good Job Hunting!!!!!

 

The Impact of Pharma Downsizing on Manufacturing Plant Closures

The Pharmalot blog today reported that pharma and biotech downsizing, restructuring and outsourcing have resulted in 38 manufacturing facilities in 2011. While this may not sound like a lot given the ongoing tough economy, the post reports that 65 facilities were closed in 2010. According to some estimates, these closures have resulted in the loss of roughly 18,000 life sciences manufacturing jobs in the past two years. Sadly, pharmaceutical manufacturing, like almost all other manufacturing jobs in the US are being lost at an unprecedented rate. Further, many of these manufacturing jobs are being outsourced to multinational CMOs or to manufacturing facilities being built by pharma companies in emerging markets like Latin America, Eastern Europe and Asia.

Not surprisingly, most of the 2011 closures were in the Northeast (8) resulting in the loss of roughly 1,400 jobs. And, not surprisingly again, one of the hardest hit states was New Jersey; home to almost all of the major pharmaceutical companies in the world. The next region that was hit hard is the Mid-Atlantic (7) with notable closures in Maryland (Shire Pharmaceuticals) and North Carolina (DSM Pharmaceutical Products).

Interestingly, while plant closures are on the rise, there is new manufacturing facility construction that may help to offset the losses. However, unlike the past, many of the new facilities are being financed by academic institutions and not-for-profits rather than life sciences companies. According to the post, roughly 106 new North American (not only the US) are underway and represent an investment value of $4.3 billion. The new Shire facility being constructed in Lexington, MA and the International Vaccine Center (InterVac) in Saskatoon, Saskatchewan were cited as examples.

Despite the constructions of several new manufacturing facilities in North America, it is obvious that most major life sciences companies are looking South and East for future pharmaceutical and biomanufacturing capabilities. The bottom line is that labor and the cost of goods are cheaper in these markets and in contrast with the past, there are skilled workforces in place to manufacture life sciences products according to American, European and Japanese Current Good Manufacturing Practices. 

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

 

And The Worst Biotech CEO of 2011 Is......

Annually, the Street.Com surveys its readers to identify the year’s worst biotechnology CEO. Yes, despite large salaries, great benefits and, in most cases, outstanding employees, the executives who make the list just can't seem to do the job right.

The 2011 survey was just released and this year’s five worst CEOs are: 

  1. Mitch Gold—Dendreon Corp
  2. Greg Divis, Jr—KV Pharma
  3. Al Mann—Mannkind Corp
  4. Joe Zakrzewski—Amarin Corp
  5. John Martin—Gilead Life Sciences

Other notable nominees included: Elan Pharmaceutical’s Kelly Martin, Genzyme’s Henri Termeer and Dan Bradbury of Amylin Pharmaceuticals.

Honorable mention awards went to Jim Bianco of Cell Therapeutics, Doug MacLellan of Radient Pharmaceuticals and Brian Culley of Adventrx Pharmaceuticals.

Despite these dubious distinctions, I would like to be earning their annual salaries and bonus compensation packages!

Until next time...

Good Luck and Good Job Hunting (I would avoid the companies whose CEOs made the list)

 

Merck Continues Its Eastward Expansion

Merck today announced that it will establish an Asia Research and Development headquarters in Beijing, China as part of a $1.5 billion commitment the company made to invest in China over the next five years.

The new headquarters will be focused on new drug discovery and development. Merck’s Asian commercial operations (known as MSD outside of the US and Canada) are located in Shanghai, China and will remain a separate entity from the new R&D center in Beijing. In addition to these facilities, MSD possesses manufacturing capabilities at many other locations throughout China.

Merck joins a growing list of big pharma companies that are rapidly establishing R&D centers in China and other emerging markets. With this in mind, don’t expect US R&D jobs to return to the US anytime soon! Now, may be a good time for American students to reconsider an anticipated career in life sciences R&D. On the other hand, the future is bright for Chinese life sciences graduate students and postdocs who are training in the US.

While Horace Greeley may have gotten it right in his day, I think the saying “Go East young man/women” may be more apt for the 21st century life sciences industry.

Until next time...

Good Luck and Good Job Hunting!!!!!!

 

Biotech Update: Samsung Biologics And Biogen/Idec To Compete In The Global Biosimilar Market

While Samsung is mostly know for flat screen televisions and other electronic appliances, one of South Korea’s largest companies has been quietly evaluating a play in the protein engineering and manufacturing space. For those of you who may not know, Korea possesses one of Asia’s most vibrant biotechnology industries. At present, there are over 600 Korean biotechnology companies in existence. In April 2011, Samsung created a business units called Samsung Biologics which specializes in biopharmaceutical manufacturing.

Today, Samsung formally announced that it would create a joint venture with America’s Biogen/Idec to develop market and manufacture biosimilar molecules. Under the terms of the agreement, Samsung will invest $255 million and garner a 85% stake in the venture which will be located in South Korea. Biogen/Idec will invest $45 million for a 15% stake in the joint venture. Samsung will take a leading role in developing and marketing the joint venture’s products whereas Biogen/Idec will contribute expertise in protein engineering and biomanufacturing. The joint venture will not develop biosimilar versions of Biogen/Idec’s proprietary, branded protein-based drugs which include Avonex (MS), Rituxan (oncology) and Tysabri (MS).

Biogen/IDEC is the first “big biotech” company to jump on the biosimilar train. The company joins Merck BioVentures and Sandoz (Novartis) as major players in the biosimilar marketplace. Teva, which began looking at biosimilars about eight years ago, is also widely believed to be a biosimilar player. While the financial fate of biosimilars is still uncertain in the US, these molecules are generally perceived as having a much higher financial upside in large emerging markets such as China, Korea, Brazil and Russia which are susceptible to government pricing controls.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

 

Ten Female Biotech Executives to Watch in 2012

Fierce Biotech conducted its annual survey to identify top female executives in the biotechnology industry. After receiving 130 nominations, they compiled a Top 10 List for 2011.  While some notable women executives may not have made it onto the 2011list, there is always next year.

Their list is as follows:

  1. Katrine Bosley—CEO, Avila Therapeutics
  2. Susan Desmond-Hellman, MD—Chancellor of USCF (formerly @ Genentech)
  3. Deborah Dunsire,MD—President and CEO, Millennium, the Takeda Oncology Company
  4. Carol Gallagher—CEO, Calistoga Pharmaceuticals
  5. Melinda Gates—Co-Founder and Co-Chair, Bill and Melinda Gates Foundation
  6. Maxine Gowen, PhD, MBA—President and CEO, Trevna
  7. Rachel King—CEO, GlycoMimetics
  8. Tina Nova, PhD—CEO Genoptix Medical Laboratory
  9. Gail Schulze—CEO& Executive Chair of the Board, Zosano
  10. Daphne Zohar—Pure Tech Ventures

If you think that someone who is not on the list deserves to be there, add a comment to this post.

Congrats to the women who made the list!

Until next time...

Good Luck and Good Job Hunting!!!!!!!

 

A Commentary: Pharma's Ongoing PR Problem

Not a day goes by without some report about pharma’s ongoing problems with illegal drug promotions, class action suits against blockbuster medications or civil or criminal settlements with state and federal governments. A quick perusal of articles posted to the Pharmalot Blog in November alone revealed no fewer than eight big pharma companies including Lilly, Merck, GlaxoSmithKline, Bayer, Pfizer, Novartis and Amgen that were involved in some sort of legal action regarding inappropriate marketing claims or failure to disclose potential side effects of blockbuster drugs. To make matters worse, a larger than usual number of pharma companies have experienced manufacturing problems that have resulted in drug recalls or shortages. This list includes companies such as Genzyme, Baxter, Johnson & Johnson, GlaxoSmithKline and most recently Boehringer Ingelheim. While chronic legal and manufacturing problems are extremely troubling (some assert it is just the cost of doing “business”), I believe that the amount of money spent lobbying Congress for legislation favorable to the industry is even more egregious.

According to a recent post on Knowledge Ecology International, the pharma industry has so far spent $115,571,832 on lobbying in 2011 (this number is sure to go higher by the end of this fiscal year). Interestingly, the biggest year for pharmaceutical industry lobbying was in 2009—a year after the Affordable Health Care Bill was passed—with totals in excess of $186,000,000. Just think about how many jobs could have been saved if companies reinvested the money into R&D rather than greasing the palms of lobbyists to induce Congress to pass laws to continue to get favorable tax rates, improve ROI and bolster the stock prices of those companies! To wit, Newt Gingrich, a Republican Presidential candidate and Former Speaker of the House has been accused of lobbying former congressional colleagues to vote for a Medicare drug subsidy while he was a paid consultant to AstraZeneca. Gingrich vehemently denies these allegations; probably because he realizes that most Americans don’t like big pharma and may vote against him if the claims are proven to be true and he wins the Republican presidential nomination.

Not withstanding the legal issues and unnecessary lobbying, what is really hurting the pharmaceutical industry is its lack of communication and transparency with patients and its unfailing practice of putting profits before healthcare. While every big pharma company I know always talks about fulfilling unmet medical needs, meeting those needs always comes at great costs (literally) to patients. Sadly, many patients can no longer afford the costs of potentially lifesaving medicines and treatments. Unless pharma begins to change the way it presents itself to the American public, it will continue to suffer the lost of confidence and trust of the American people. And, if the industry is unable to regain the public’s trust, its inability  will ultimately result in legislation that allows the US government to control drug prices: something that exists in most other countries in the world and big pharma has been desperately trying to prevent for the past 50 years!

Until next time...

Good Luck and Good Job Hunting!!!!!!

 

Despite Near-Record Recalls, the Price of Prescription Drugs Continues to Rise

Ed Silverman, the intrepid author of the Pharmalot Blog, reported today that the average price of prescription drugs through last month rose 7.2 per cent; which tops the annual price rate increases over the past decade. The cost analysis was done on 130 prescription drugs.

The biggest winners were: Suboxone, marketed by Reckitt Benckiser to treat opioid addiction which rose 21 percent. Cephalon raised the price of its Provigil narcolepsy pill by 15 percent and Sunovion Pharma hiked the prices of its Xopenex asthma and COPD med by 9.8 percent. Other drugmakers on the list included Genentech, Merck and Abbott Laboratories.

Ed cautioned that “the price changes are based on WAC, or wholesale acquisition cost, for more than 90 percent of the drugs, which means that less than 10 percent of increases are based on direct price or suggested wholesale price” Nevertheless, any wholesale price increases are always passed on to the end users aka patients!

It is troubling that in these tough economic times that drug prices continue to rise at unprecedented rates. And access to reasonably priced medicines continues to diminish.  Not surprisingly, prices continue to rise in advance of healthcare reform legislation that doesn’t kick in entirely until 2014.

Until next time

Good Luck and Good Job Hunting!!!!!!!

 

The Number of Prescription Drug Recalls Continues to Rise

Last week, I reported in a post that in 2011 the US Food and Drug Administration (FDA) had approved a near-record of 35 new medicines. Coincidentally, earlier this week, Ed Silverman posted on the Pharmalot blog that prescription drug recalls are rising and nearing historical records. 

According to Ed, “During the third quarter of this year, the number of pharmaceutical recalls jumped to 150, compared with about 90 recalls during each of the first two quarters of 2011, according to FDA Enforcement Reports. Moreover, the recent tally dwarfs the roughly 65 recalls that were made during the last quarter of 2010 and nearly doubled the 80 recalls that were notched during the 2010 third quarter.”

The reason for the spike in drug recalls? Some suggest that FDA is getting tough and still trying to reinvent itself after the 2004 Vioxx debacle and the tainted heparin incident. Also, Congress is putting pressure on the agency to better enforce manufacturing regulation and supply chain management practices. Sadly, the only way for FDA to accomplish this is by increasing the number of inspections that it conducts on both foreign and domestic manufacturing facilities. And, given that the agency’s budget for enforcement activities has not increased much over the past few years; it is unlikely that increased regulatory scrutiny will occur any time soon.

Finally, for those of you who may not know. FDA does not have the authority to recall drugs. Recalls are voluntary and must be orchestrated by the company that manufactures the product in question. Luckily, FDA has many financial and legal methods at its disposal to induce companies to “voluntarily” recall suspect or tainted products from the US market.

Until next time...

Good Luck and Good Job Hunting!!!!!!

 

In Case You Were Wondering: FDA Approved 35 New Prescription Medicines This Year

Last week, the US Food and Drug Administration issued a press release lauding its approval of 35 new prescription medications in FY2001. According to the release 2011 was a banner year for drug approvals; being only surpassed in FY2009 when 37 new medicines garnered regulatory approval.

FDA detailed its accomplishments in a report entitled “FY2011, Innovative Drug Approvals” which touted faster approval times in the United States as compared with the FDA’s counterparts around the globe. Twenty-four of the 35 approvals occurred in the United States before any other country in the world and also before the European Union, continuing a trend of the United States leading the world in first approval of new medicines. 

Among this year’s highlights:

  1. Two of the drugs – one for melanoma and one for lung cancer – are breakthroughs in personalized medicine. Each was approved with a diagnostic test that helps identify patients for whom the drug is most likely to bring benefits;
  2. Seven of the new medicines provide major advances in cancer treatment;
  3. Almost half of the drugs were judged to be significant therapeutic advances over existing therapies for heart attack, stroke and kidney transplant rejection;
  4. Ten are for rare or “orphan” diseases, which frequently lack any therapy because of the small number of patients with the condition, such as a treatment for hereditary angioedema;
  5. Almost half (16) were approved under “priority review,” in which the FDA has a six month goal to complete its review for safety and effectiveness;
  6. Two-thirds of the new approvals were completed in a single review cycle, meaning sufficient evidence was provided by the manufacturer so that the FDA could move the application through the review process without requesting major new information;
  7. Three were approved using “accelerated approval,” a program under which the FDA approves safe and effective medically important new drugs quickly, and relies on subsequent post-market studies to confirm clinical benefit. For example, Corifact, the first treatment approved for a rare blood clotting disorder, was approved under this program
  8. Thirty-four of 35 were approved on or before the review time targets agreed to with industry under The Prescription Drug User Fee Act  (PDUFA), including three cancer drugs that FDA approved in less than six months.

PDUFA was established by Congress in 1992 to ensure that the FDA had the necessary resources for the safe and timely review of new drugs and for increased drug safety efforts. The current legislative authority for PDUFA expires on Sept. 30, 2012. 

Maybe the agency can keep its streak alive before  PDUFA expires next year!

Until next time...

Good Luck and Good Job Hunting!!!!!

 

Occupy Novartis?

Angry with recent job cuts announced by the Swiss pharmaceutical giant Novartis, protesters, this past Saturday, gathered in Basel and beside the villa of its former CEO and Chairman Daniel Vasella to express their displeasure with the company’s decision to layoff workers.

In Basel, about 1,000 people gathered and demanded that Novartis reverse its decision to layoff 1,100 people who work at the company. Meanwhile, about 20 protestors gathered in a field opposite Vasella’s walled lakeside Mansion. Two of the protestors handed Vasella a “fake pink slip” and according to witnesses he laughed and took the gesture in stride.

Vasella, who is not a stranger to protests, is one of Switzerland's highest-paid executives and in 2009 animal rights activists set fire to his Tirolean hunting lodge to protest Novartis’ use of animals to test pharmaceuticals and consumer products. 

Currently, the Occupy Wall Street movement in the US has primarily targeted banks and financial institutions. However, two weeks ago, a group of protestors in Croton, CT, staged a demonstration at Pfizer headquarters to express their anger a recent layoffs announced by the company.

Until next time...

Good Luck and Good Job Hunting!!!!!!!

 

So Much for The Promise of RNAi!!!

Several years ago RNAi was hot and it was touted as a technology that would revolutionize modern pharmaceutical science. I never thought RNAi had much promise beyond being a research tool but what do I know? 

With this in mind, I felt exonerated today after reading that Roche had divested all of its RNAi assets to a small Madison, WI drug discovery company called Arrowhead Research. In exchange for the assets, Roche acquired an equity position in the company.  About a year ago Roche formally announced that it was exiting the RNAi business, but until now was unable to find a buyer. 

According to a press release, Arrowhead now owns the Roche Madison Inc facility (formerly the Mirus R&D facility in Madison, WI), which employs a team of 40 scientists. Arrowhead also gets licenses from several leading firms, including Tekmira Pharmaceuticals for RNAi drug delivery technology and Alnylam for RNAi intellectual property and short interfering RNA structures. Arrowhead was already in the RNAi delivery space.

Previously, Roche spent roughly a half-billion dollars to amass its position in RNAi, including $331 million paid to Alnylam Pharmaceuticals in 2007 for access to RNAi technology and $125 million for the purchase of Mirus Bio in 2008. Arrowhead, in contrast, is paying Roche no money for these and other assets; instead it is giving the Swiss firm an ownership stake of slightly under 10%.

Many other big pharma companies have also abandoned their efforts in the RNAi space. While RNAi works in the lab as a research tool, the inability to successfully deliver it to internal cellular targets has prevent companies from commercializing it. I hate to say it, but “I told you so.”

Until next time....

Good Luck and Good Job Hunting!!!!!!!!

 

The Impact of Consolidation on Pharmaceutical R&D

Over the past 10 years or so there has been an enormous amount of consolidation in the life science industry. While this activity has been very good for shareholders, it has had a devastating effort on pharmaceutical R&D says John  LaMattina PhD, a chemist, blogger, author and former President of Pfizer Global R&D.

In his article “The Impact of Merger on Pharmaceutical R&D," LaMattina asserts:

“Mergers and acquisitions of pharmaceutical companies over the past 15 years have had a major consequence on the internal research and development productivity of these organizations. Industry consolidation has eliminated a high degree of competition and resulted in the downsizing of internal research efforts. The execution of these mergers has caused a loss of momentum in the development pipelines of these companies along with loss of scientific talent.”

In addition, he believes that M&A and outsourcing of R&D operations has resulted in the loss of scientific talent required for innovation and development of novel new medicines. “Sadly, this loss of innovation comes at a time when we are trying to find treatments for challenging and difficult-to-treat diseases like Alzheimers and many cancers” says LaMattina.

While most life sciences executives believe that consolidation is good for business, LaMattina, along with John Lechleiter, the outspoken CEO of Eli Lilly& Co (who is also a PhD-trained chemist) believe that continued consolidation in the industry will have devastating consequences. “We are still very much opposed to a large-scale combination. We don’t think size is necessarily supportive of innovation.” says Lechleiter. 

LaMattina added “Downsizing R&D hinders the ability of companies to develop new drugs because they lack the scientific expertise required to make critical decision as a drug candidate makes it way through the pipeline.”

Unfortunately, most current pharmaceutical and life sciences executives don’t think like LaMattina. Since 2001, over 300,000 pharmaceutical employees, mostly R&D scientists and sales representatives have lost their jobs.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!

 

Bristol-Myers Squibbs Shuffles Its Senior Management Team

Bristol-Myers Squibb (BMS) announced today that it had made major changes to its senior management team which is now headed by CEO Lamberto Andreotti.

Giovanni Caforio has been promoted to president, U.S. Pharmaceuticals. Caforio was most recently senior vice president, Oncology and Immunology Global Commercialization. In his new role, Caforio will report to Lamberto Andreotti, chief executive officer, and has been named a member of the Company's Senior Management Team.

In addition, Charles Bancroft and Béatrice Cazala have been appointed Executive Vice Presidents of Bristol-Myers Squibb. Bancroft will add to his role of Chief Financial Officer operational responsibility for the pharmaceutical business in Latin America, Middle East, Africa, Canada, Japan and several other countries in the Pacific Rim. Cazala will add responsibility for global policy to her role leading Global Commercialization, Europe and Emerging Markets. Both will continue to report to Andreotti and serve on the Company's Senior Management Team.

Anthony C. Hooper, senior vice president, Commercial Operations, and president, U.S., Japan and Intercontinental, has decided to leave the company. Hooper, a long time member of BMS's senior management team was obviously not on board with Andreotti's vision for the company's move to become a next generation biopharma company.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!!

 

Consolidation Continues in the US Life Sciences Industry

Earlier this week Roche Holding AG announced that it would pay $230 million to acquire the San Diego, CA-based biopharmaceutical company Anadys. The reason for the acquisition is to bolster Roche’s standing in the hepatitis C market which is projected to grow to as much as $15 billion annually by 2019.

Anadys has a fairly large experimental pipeline of hepatitis C drugs, the most advanced candidate being setrobuivr that is being clinically tested in combination with the generic antiviral drug ribavirin and Pegasys (PEGylated α-interferon) as a hepatitis C treatment.

The Anadys deal comes on the heels of an agreement last week between Roche and Merck & Co to jointly market hepatitis C treatments in the US. Merck recently won approval last May for Victrelis (boceprevir) the first new hepatitis C treatment in over a decade. Also, late last month Vertex Pharmaceuticals received approval for a new hepatitis C drug called Incivek (telaprevir). Anadys is also conducting early clinical trials on ANA773 as a possible treatment for hepatitis C infection, cancer and other chronic diseases.

In other news, GlaxoSmithKline (GSK) is rumored to be contemplating purchasing Maryland-based Human Genome Sciences (HGS), which recently received US approval for Benlysta a novel monoclonal antibody treatment for the autoimmune disease systemic lupus erythematous. 

Benlysta was the first new drug to be approved to treat lupus in over 50 years. GSK is HGS’s commercialization partner for Benlysta which is expected to be a blockbuster drug. The reason for the takeover rumors is likely HGS’s stock price which has fallen from 52-week high of $30 to its current value of $15 per share. 

Until next time...

Good Luck and Good Job Hunting!!!!!!!

 

Breaking Up Is Hard to Do: Abbott Labs Announces Plans to Split into Two Separate Companies

Abbott Laboratories today announced that it will split itself into two companies by spinning off its branded prescription drug business and creating a second company responsible for its medical implants, diagnostic tests and baby formula businesses.

The pharmaceutical company will exclusively sell its branded prescription drugs (including its blockbuster biologic Humira) and will be lead by Abbott’s Richard Gonzalez who currently head the company’s pharmaceutical business. Current Abbott CEO Miles White will lead the diversified medical products company. 

The reason for the split is to allow investors to value each of the companies on their distinct characteristic. Abbott’s decision to split the company is consistent with the prevailing notion that companies that sell both prescription drugs and consumer products don’t perform well. This led Bristol Myers Squibb to sell off its medical devices and consumer products divisions several years ago. Interestingly, prescription pharmaceuticals/consumer products/medical devices were de rigueur in the 1990s and early 2000s. Abbott’s decision leaves companies like Pfizer, Novartis and Johnson & Johnson as examples of the few remaining companies that still house pharmaceuticals, devices and consumer goods under one roof. Don’t be surprised if in the future these companies also decide to spin off or divest themselves of their consumer goods/medical devices divisions.

Finally, while the split may be good for investors, it may not be that great for Abbott employees. Usually, spin offs or divestitures

Until next time..

Good Luck and Good Job Hunting!!!!!!!!!!!!!!

 

A New Way Forward for FDA?

Last week, US Food and Drug Administration (FDA) Commissioner unveiled a “blueprint” that contained immediate and actionable steps that can be taken to spur innovation in the life sciences. The report’s proposals stem from a review of FDA’s current policies and practices, as well as months of meetings with major stakeholders nationwide, including key industry leaders, small biotech, pharmaceutical and medical device company owners, members of the academic community, and patient groups. Entitled “Driving Biomedical Innovation: Initiatives for Improving Products” the report focuses on seven major actions:

  1. rebuilding FDA’s small business outreach services
  2. building the infrastructure to drive and support personalized medicine
  3. creating a rapid drug development pathway for important targeted therapies
  4. harnessing the potential of data mining and information sharing while protecting patient privacy
  5. improving consistency and clarity in the medical device review process
  6. training the next generation of innovators
  7. streamlining and reforming FDA regulations

The blueprint was issued in response to growing concerns that—despite record investments in biomedical R&D—the drug pipelines at many US life sciences companies has grown exceedingly thin. Not surprisingly, most life sciences companies blame the agency for the thinning pipelines but in reality both side have contributed to the problem. Hamburg’s bold plan seems reasonable. But, it can only be implemented if Congress provides sufficient funding to underwrite the new initiatives proposed in the plan. And, while these funds ought to be allocated, it is not clear whether or not it is likely given the poor economy and the current, unprecedented political divisiveness that exists in Washington these days.

Moreover, Mark Senak, author of the Eye on FDA blog, suggests that FDA can improve its effectiveness by learning how to communicate better with its stakeholders. Mark, a social media advocate provides this compelling insight into FDA’s communication problems and the agency’s inability to grasp that the Internet and social media can help to improve its communication skills:

"The extremely long track record of FDA in attempting to figure out the Internet (first public meeting held in October 1996) and social media (first public meeting held in November, 2009) has yielded no guidance, with little transparency into the process.  It is time for FDA to seek outside communications expertise to help the agency better formulate policy on a timely basis."

While I believe that Commissioner Hamburg’s blueprint for improvement is a good one, it isn’t clear whether she will get the necessary support to implement it.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

 

Occupy Wall Street Protest Targets Pharmaceutical Giant Pfizer

The Pharmalot Blog today reported that a group of protesters aligned with the Occupy Wall Street movement will conduct a vigil at Pfizer's Groton,CT R&D facility to protests recent job cuts made by the company. 

Pfizer was targeted because it took tens of millions of dollars in local and state government subsidies to build an R&D facility in New London, Connecticut. But earlier this year, the company abandoned the facility and decided to transfer about 1,100 R&D job from Groton to Cambridge, Massachusetts.Also, the company jettisoned its antibacterial drug discovery efforts at the Groton facility and shipped those jobs overseas to China.  Roughly, 2,500 Pfizer jobs are leaving Connecticut which will likely have a negative impact on the state.

One protest leader quipped “When huge companies like Pfizer take tens or hundreds of millions of dollars in public money, and then pull up stakes as soon as the money disappears, that’s what wrong with our economy”

Also, Pfizer is one of the top US ten companies to shed employees despite an estimated $48.2 billion in offshore funds that the company does not pay any taxes on. Between 2004 and 2011, the company  laid off  58,071.

Don't be surprised if the Occupy Wall Street Movement spreads from the banking to the pharmaceutical industry.  At this point there appears to be little distinction between the two!

Until next time...

Good Luck and Good Job Hunting

Sanofi Invests $300 Million in a Vaccine Manufacturing Facility in India

I am not sure how I missed this announcement last week but Sanofi Aventis will invest $300 million in a vaccine (biologics) manufacturing facility in India. The investment is in addition to the $784 million that Sanofi paid two years ago to acquire the Indian biologics company Shanta Biotech.

Sanofi executives originally thought that the purchase of Shanta would give immediately give them biologics manufacturing capability in South Asia. This did not occur because of manufacturing problems with the existing Shanta facility.  Sanofi claims to have corrected the manufacturing issues and investment of an additional $300 million into the facility is to bolster both R&D and manufacturing capacity. The new manufacturing facility is consistent with Sanofi’s publicly announced strategy of earning as much as 40 percent of its profits in emerging markets by 2015.

Like China, emerging markets like India, Brazil and Russia will be squarely on big pharma’s radar for the foreseeable future.

Until next time...

Good Luck and Good Job Hunting (in India!)

 

Astra Zeneca to Invest $200 Million in New Manufacturing Facility in China

British pharmaceutical giant AstraZeneca today announced that it would invest $200 million into a new manufacturing facility located in China Medical City in Jiangsu province in Eastern China. This is the company’s largest global investment ever in a single manufacturing facility. The new plant which will be completed by 2013 will manufacture intravenous and oral solid drugs. 

AstraZeneca was one of the first Western pharmaceutical companies to establish a presence in China (1993) and has fast become one of the leading biopharmaceutical companies in the country doing about $1.0 billion in business annually. 

Many of Astra Zeneca’s competitors including Novartis, Roche, Merck & Co. and others have also recently made large investments into Chinese R&D and manufacturing facilities. If this doesn’t eliminate anyone’s doubt that pharma is shifting its focus from the West to emerging markets, I am not sure what will!!! While this shift may be bad news for American life scientist seeking employment, it is certainly welcome news for Chinese Nationals who received their life sciences training in the US and other Western nations.

Until next time...

Good Luck and Good Job Hunting (there are openings in China!!!!!!)

 

Parity for Women in the Workplace Is Still Lacking

Despite the fact that women in the US earn nearly 60 percent of four-year college degrees and make up almost half of the American workforce, women held about 14 percent of senior executive positions at Fortune 500 companies. An even lower percentage of female scientists hold tenure track faculty positions. 

Sadly, the number of female executives hasn’t budged since 2005 nor has there been an increase in appointment of women scientists to tenure track positions. This phenomenon is analyzed in a recent article written by Phyllis Korkki entitled “For Women, Parity IS Still a Subtly Steep Climb.” Experts interviewed in the article contend that the inability of women to reach parity in the workplace can be attributed to “entrenched sexism” in the workplace that is present both sexes. Ms Korkki describes how this plays out in the workplace and how it can be overcome by both men and women. 

The article is a fascinating and insight read: I highly recommend it!!!!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!!

 

Maximizing Patient Engagement During Clinical Trials

Recruiting, retaining and managing patients that participate in clinical trials for approval of new medicines and devices have becoming very challenging in the past decade or more. Ironically, the ready availability of experimental new medicines in the US for certain therapeutic areas including oncology, neuroscience and vaccines have forced life sciences companies and CROs to conduct many Phase I and Phase II trials outside of the US. In turn, the globalization of clinical trials has forced many sponsors to increasingly rely on e-based and mobile solutions for patient recruitment, retention and compliance.

The Advance Learning Institute’s conference entitled “Patient Recruitment, Compliance And Retention For Clinical Trials: Integrating The Latest Technologies With Traditional Tools To Maximize Patient Engagement” that will be held in Manhattan on October 24-26, 2011 will provide attendees with insights into the best practices to maximize patient engaged in clinical trials. Presentations will be given by a variety of pharmaceutical companies, CROs and academic institutions including Pfizer, Merck Research Laboratories, Shire Pharmaceuticals, Celgene Corporation, Quintiles, Omniscience Mobile, Albert Einstein College of Medicine and the Michael J. Fox Foundation for Parkinson’s Research. A complete agenda for the conference can be found here.

Those of you who mention BioJobBlog or BioCrowd when registering for the conference will receive a $200 registration discount.

See you at the meeting!!!!!!!

Until next time...

Good Luck and Good Job Hunting!!!!!!!

 

Biosimilar Regulatory Guidance is Imminent

Late last week, Janet Woodcock, head of the US Food and Drug Administration’s (FDA) Center for Drug Evaluation (CDER) made public comments which suggested that the long awaited guidance for approval of biosimilar products in the US was complete and likely to be issued by the end of this year. According to the Pharmalot Blog, another agency official suggested that the guidance may be “as early as the next few weeks, maybe even days.” Conventional wisdom suggests that the end of the year scenario may be more likely!

As widely anticipated, the guidance will resemble that already in place in Europe and will rely heavily upon analytical similarity of the biosimilar to the innovator product to determine the clinical testing requirement for approval of the molecule. Interestingly, Woodcock went out on a limb and suggested that the FDA approval process may make interchangeability feasible for biosimilars. For those who may not know, interchangeability or substitution allows pharmacists to substitute generic small molecules drugs for brand names when filling a prescription. This practice is legally allowed by the Hatch Waxman Act because FDA approval of a generic indicates that it biologically equivalent or identical to the branded molecule.

For those of you who have not close paid attention to the biosimilar brouhaha, a regulatory approval pathway for these molecules was implemented in Europe in 2004. Since that time, at least 10 biosimilar products have reached European markets. At present, biosimilars are still not legal in the US. While Woodcock and other FDA officials may be proud of their progress, why has it taken over 12 years for the agency to divine regulatory guidance for this class of molecules? 

Until next time...

Good Luck and Good Job Hunting!!!!!!

 

Biotechnology Pioneer Enzon Pharmaceuticals Cuts It Workforce in Half

Piscataway, NJ-based Enzon Pharmaceuticals, the once venerable biotechnology that was the first to successfully commercialize protein PEGylation, yesterday announced that it plans to lay off nearly half its employees by the second quarter of next year.

The layoffs will leave Enzon with 47 employees. The company said that the layoffs are intended to align resources with the company's research and development activities. Enzon, once with a market valuation greater than Merck pharmaceuticals, has been steadily losing revenue over the past 10 years and had essentially abandoned R&D in the protein PEGylation field that it had pioneered. Over the same time period, the company had a succession of CEOs, each of whom had a different vision and strategic plan forward.

Enzon was founded in 1982 by Abe Abuchowski, PhD, who validated the commercial possibilities for protein PEGylation while a graduate student at Rutgers University. Abuchowski licensed the rights to protein PEGylation and formed Enzon several years after receiving his PhD degree. He took the company public in 1985 (a feat that was not easy to accomplish back in those days) and went on to use protein PEGylation to develop two products with orphan drug designations (Adagen and Oncospar) and PEG-Intron a second generation biopharmaceutical used to treat Hepatitis C infections.

Abuchowski was CEO and Chairmen of Enzon until 1996. He left the company that he created because its board decided that PEGylated small molecules rather than proteins ought to be the future focus of the company. Enzon abandoned its biopharmaceutical focus in favor of small molecules in the late 1990s. Although in recent years the company tried to resuscitate its protein PEGylation programs, the PEGylation industry had essentially passed the company by and they were no longer competitive.

Abuchowski is currently CEO and Chairman of Prolong Pharmaceuticals, a South Plainfield, NJ-based, company developing products targeting the treatment of anemia resulting from oxygen deficiency. Not surprisingly, many of the products in the company’s pipeline were developed using protein PEGylation technology. While others have contributed to the protein PEGylation field, Abuchowski is generally recognized as the first person to commercialize the technology. He has received numerous awards for his work in protein PEGylation; a technology that generates roughly $30 billion in drug sales annually.

Until next time...

Good Luck and Good Job Hunting!!!!!!!

 

More Workforce Diversity is Needed in the Life Sciences

As scientists, we all  subscribe to the notion that diversity is a critical component to the evolution of any species. While we this is a well known fact, the life sciences industry, like others, struggles with workforce diversity mainly in the area of research and development. For example the number of minority students—blacks and hispanics—who receive PhD degrees is miniscule as compared with their white counterparts.  Graduate schools struggle to promote diversity in their programs but their efforts to date have been lackluster.

One of the factors that contribute to the lack of representation of minority students in the life sciences may be the lack of access to equal educational opportunities. With this in mind, the folks over at onlinecolleges.net sent me a post that has a plethora of information about the state of minority education in the US. I culled relevant information from the list and reproduced it for this post.

Stereotyping impairs performance

A startling Ohio State University study exploring the effects of racial stereotyping uncovered some very unfortunate truths. Nearly 160 African-American students were asked to write an essay about an average college student, either named "Tyrone" or "Erik," with the implication being that the former is black and the latter white. Those assigned Tyrone scored an average of 4.5 on a standardized test, while Team Erik ended up with 6.2. Although possessing equal academic aptitude, researchers believe prevailing stereotypes negatively impact performance — thus creating an unjust cycle reinforced by students and teachers alike. 

Hispanic high school students had the highest dropout rate in 2009

The National Center for Educational Statistics shows that 17.6% of Hispanic high school students drop out before completing their diplomas or GEDs. Reasons vary from kid to kid, of course, and do not necessarily denote poor grades or discipline. On a positive note, however, Hispanic dropout rates decline steadily every year, with 2008 seeing 18.3% of the high school population leaving before graduating. 

Minorities comprise 32% of undergraduate enrollees

Undergraduate enrollment has actually increased among all racial and ethnic demographics, although minorities remain heavily underrepresented on American college campuses. Only 32% of postsecondary students are minorities as of 2004 statistics, but their numbers increase yearly — certainly a positive trend. Between 1976 and 2004, Asians and Pacific Islanders experienced the highest rate of increase, boasting a whopping 461%. So while the number still seems low these days, minorities are definitely catching up on campus and enjoy more opportunities to have their voices heard and heeded.

Minorities comprise 25% of graduate enrollees

With increased minority undergraduate enrollment came more representation in graduate programs, though at a slower pace. 2004 statistics showed that 25% of master’s and doctoral students were minorities, up from 11% in 1976. The most rampant increase occurred among Hispanics, at 377%. Once again, there’s absolutely nothing "scary" about more opportunities and representation in higher education. But the numbers could definitely be higher, especially since more enrollees means more imperative to address diverse needs.

Minorities comprise 10.2% of private school principals

In total, of course, as statistics vary rapidly depending on what — if any — denomination owns and operates the schools in question. Seventh-Day Adventist institutions lead the way, with 26.4% minority principals. Administrators of black, non-Hispanic or Latino descent are most prevalent, particularly in Seventh-Day Adventist (17.7%) and Pentecostal (14.7%) schools. They also make up 5.2% of total minority principals. When it comes to private education, more needs doing to ensure minority students and staff alike see their requests properly met.

The majority of black and Hispanic students attend high-poverty schools

Statistics from 2005 school year revealed that black and Hispanic students populate high-poverty schools more than any other minority. The National Center for Education Statistics considers "high-poverty schools," which are those with 75% or more attendees receiving free or reduced-price lunches. Forty-eight percent of black and 49% of Hispanic 4th graders hail from such desperately wanting institutions, while Asians and Pacific Islanders are more evenly distributed across economic demographics. 

Hispanic and black students are less likely to have internet access at home

Because of this, they adapt to classroom technology at a slower pace than their white, Asian and Native American peers. Twenty-six percent of Hispanic and 27% of black students use the internet at home, compared to 58% of Asian and 47% of Native American kids, resulting in a very unfortunate achievement gap. Numbers are improving, of course, but there’s still a ways to go before the gulf starts shrinking.

Schools with black or Hispanic majorities are more likely to hire underqualified or novice teachers

In fact, 25% of math educators at schools with 50% or more black students do not hold a degree or any other qualifications in the subjects they teach — probably the most egregious example. And once said teachers rack up the experience, they usually flee to more affluent (and white) areas. Such an unfortunate and enduring phenomenon plays a major role in perpetuating, if not outright widening, the achievement gap. Without knowledgeable, experienced and engaged teachers, students in affected schools typically lag behind and never receive the academic opportunities that should be afforded all youngsters. 

More black students repeat grades than any other racial or ethnic demographic

Both genders, too. In 2007, 25.6% of black males and 15.3% of black females between kindergarten and 12th grade had repeated at least one grade. These numbers, though, only reflect the issue as it relates to public school students. 

More black students receive suspensions and expulsions than any other racial or ethnic demographic

Between 6th and 12th grades, the 2007 school year saw 49.5% of black males and 34.7% of black females reporting that they had received at least one suspension in their academic careers. When it comes to expulsions, 16.6% of males and 8.2% of females said they had been dismissed from school at least once.

Hispanic teenagers have the highest pregnancy rate

In 2007, 81.7 out of every 1,000 Hispanic teenage girls gave birth — more than any other race or ethnicity. Across all demographics, however, the numbers are steadily decreasing.

This probably has something to do with improved sex education and easier access to necessary birth control devices, though the problem still requires considerable intervention. Especially since popping out babies as a high schooler is all trendy these days.

Clearly, until some of these problems are addressed, then it is likely that workforce diversity in the life sciences will continue to lag.

Until next time...

Good Luck and Good Job Hunting!!!!!

 

Employment Update: Some Biomanufacturers and Biotech Companies are Expanding!

While big pharma companies continue to shed jobs, there are some indications that the biotechnology industry is beginning to pick up some steam. For example, Boehringer Ingelheim (both a drug development and biomanufacturing company) is planning a $383 million expansion of its facilities in Ridgefield, CT. Likewise, Cary, NC-based Biologics a biotech cancer treatment company expects to almost double it staff from 85 to about 150 employees by the end of 2012. Finally, Gilead Sciences is undertaking a massive expansion of its Foster City corporate headquarters and expects to increase its workforce there from 1,700 to as many as 3,400 workers.

Although these expansions are only a few in number, they may be a harbinger of things to come in the US life sciences industry. One can only hope!

Until next time...

Good Luck and Good Job Hunting!!!!!

 

US Global Competitiveness Continues Its Downward Slide

The US is slipping and emerging markets are growing in competitiveness according to an annual list compiled by the World Economic Forum. Perhaps even more troubling is that the same group found that the US is lagging in the adoption of internet, computing and mobile communication technologies. After all, adopting of new technologies has been widely viewed as a means to improve competitiveness.

According to the report, the US, which topped the list in 2008, slid from number 4 last year to number 5. Surprisingly, for the third year in a row, Switzerland ranked first. The list is compiled by assessing 12 categories that include innovation, infrastructure and the world economy. The fact that many EU countries continue to improve in their ability to compete on a global scale, suggests that socialist-leaning governments may not be as bad as many free market US zealots would have you believe!

Singapore replaced Sweden for the number 2 position in this year’s list. Behind Sweden (no. 3), Finland was ranked fourth, and Germany was ranked sixth. Germany was followed by the Netherlands and Denmark. The UK was 10, France was 18th and China moved up one place to 26 this year. Among other major Asian economies, Japan ranked ninth and Hong Kong 11th

Among other major emerging economies, South Africa was 50th, Brazil 53rd, India 56th and Russia 66th.

The weaker performance of the US was attributed to economic vulnerabilities and low public trust in politicians and concerns about government inefficiency. The loss of US competitive coupled with fewer students opting for careers in science, technology, engineering and math (STEM) and poorer adoption rates of new technologies suggests that the US decline will continue.

Until next time...

Good Luck and Good Job Hunting!!!!

 

The Cannabis Genome Is Sequenced

 A Massachusetts start up company called Medicinal Genomics announced late last week that it had sequenced the cannabis genome. Kevin McKernan the head of Medicinal Genomics and former leader of Life Technologies Corp Ion Torrent DNA-sequence program decided to undertake the project after he read a paper in Nature describing the possible tumor shrinking effects of marijuana. 

The project, which cost about $200,000, may lead to the development of treatments for cancer, pain and inflammatory diseases said McKernan. He is making the making the data public using Amazon.com Inc. (AMZN)’s EC2 cloud- computing system. McKernan called the work a “draft assembly” and has yet to publish the data in a peer reviewed journal.

 While sequencing the cannabis genome is not a novel feat, McKernan said his company’s goal is to allow researchers to find ways to maximize the cannabis plant’s therapeutic benefits and minimize its psychoactive effects. Cannabinoids, a class of chemicals that includes tetrahydrocannabinol, or THC, are the main psychoactive substance in marijuana. Another compound called cannabidiol, or CBD, has shown promise in shrinking tumors in rats without the psychoactive effects, McKernan said. 

Companies including England-based GW Pharmaceuticals have used THC and CBD to create cannabis-based medicines like Sativex; indicated for muscle spasms related to multiple sclerosis. McKernan contends that the sequence data may help to modify the cannabinoid pathways in the plant or introduce the pathways into other hosts to optimize biological production. “It may be possible through genome directed breeding to attenuate the psychoactive effects of cannabis, while enhancing the medicinal aspects” he said. 

Like it or not, marijuana has a variety of outstanding medicinal properties that can help patients suffering from chronic or terminal illnesses. The politicization of the drug and the impact of its legalization on the US law enforcement and prison systems have prevented the use of marijuana as a bonafide therapeutic agent.  It is troubling to think that highly addictive pain medications like oxycodone and hydrocodone/paracetamol are legal but marijuana is not.

 Until next time...

Good Luck and Good Job Hunting!!!!!!!

 

FDA Approves a First-Ever Scorpion Sting Treatment: Who Knew?

While there is enormous unmet medical need out there, I never knew that the morbidity and mortality resulting from scorpion stings was so great. But, as the old adage goes; you learn something new everyday. To wit, the US Food and Drug administration earlier this week approved the first-ever treatment for scorpion stings.

According to a press release about the new product called Anascorp

 “Venomous scorpions (Centuroides) in the U.S. are mostly found in Arizona. Severe stings occur most frequently in infants and children, and can cause shortness of breath, fluid in the lungs, breathing problems, excess saliva, blurred vision, slurred speech, trouble swallowing, abnormal eye movements, muscle twitching, trouble walking, and other uncoordinated muscle movements. Untreated cases can be fatal.”

Anascorp, Centruroides (Scorpion) Immune F(ab’)2 (Equine) Injection, is made from the plasma of  horses immunized with scorpion venom. Anascorp may cause early or delayed allergic reactions in people sensitive to horse proteins.

FDA approval of Anascorp was based on results from a randomized, double-blind, placebo-controlled trial of 15 children with neurological signs of scorpion stings. The data showed that neurological symptoms resulting from scorpion stings resolved within four hours of treatment in the eight subjects who received Anascorp, but in only one of the seven participants who received the placebo. Of course, as is the case with ALL medications, the most common side effects were vomiting, fever, rash, nausea, itchiness, headache, runny nose, and muscle pain. In total, safety and efficacy data was collected from 1,534 patients in both open-label and blinded studies.

Anascorp was designated as an Orphan drug by FDA and received priority review. It is licensed to Rare Disease Therapeutics Inc., Franklin, TN, distributed by Accredo Health Group Inc., Memphis, TN, and manufactured by Instituto Bioclon, S.A. de C.V., of Tlalpan, Mexico, D.F.

Obviously, Anascorp is not likely to be a blockbuster product. But, if you are in the US Southwest and inadvertently are stung by an American scorpion you can rest assured that you will no longer have to worry about dying or suffering neurological damage. This news allows me to sleep better at night!

Until next time...

Good Luck and Be Careful Out There!!!!!!!

 

The Inside "Poop" On the Life Sciences Industry

I attend this year's BIO meeting in DC and ran into an old friend, Stan Yakatan of Katan Associates.  For those of you who do not know Stan, he has been associated in a variety of capacities within the Life Sciences industry for the past 35 years.

The job titles that he has accrued over his career include CEO, Chairman, Managing Director, Board Member, Investor, Entrepreneur and Mensch!  Hanging out with Stan at life sciences meetings is always interesting, exciting, unpredictable and most often fun!  That said, Stan is a wealth of information about the life sciences industry and I was surprised to learn that he has an invterview video on YouTube!

To that end, I thought it would be interesting to post the interview @BioJobBlog.  Stan's historical and current perspective on the US life sciences industry is interesting to say the least!

 

 

If you want to contact Stan please click here!

Until next time...

Good Luck and Good Job Hunting!!!!!!!

BioJobBlog Update

Some of you may have noticed that I have not been uploading new posts as frequently as I have in the past.  I have been blogging @BioJobBlog for the past five years and quite frankly I need a little break. Traffic at the site is typically lower during the summer months so I decided to ratchet back a bit and think about the future direction of the blog.  That said, I will be writing new posts from time to time but will not be back to full time blogging until after Labor Day.

Those of you who may be interested in guest blogging please contact me and we may be able to work something out.  Also, any persons interested in advertising @ BioJobBlog ought to contact me for pricing.

I want to thank those of you who have helped to make the blog a success by reading it!  At present, BioJobBlog averages between 60,000 to 65,000 unique hits per month! I hope to continue to grow its readership in the future. To that end, I welcome any ideas, suggestions, kudos, kvetches etc to help me to reach that goal.

Until next time... 

Good Luck and Good Job Hunting

 

Are US Immigration Laws Really Hurting Life Science Innovation?

A report in Bloomberg News today suggested that Eli Lilly & Co. Chief Executive Officer John Lechleiter, PhD told a technology conference today that unfavorable US permanent resident (green card) laws are to blame for declining US innovation in the life sciences. With this in mind, Lechleiter plans on calling for US immigration officials to issue more green cards and adopt a shorter and simpler process for highly skilled foreign nationals to gain permanent residence in the US. According to Dr. Lechleiter, one of only a handful of big pharma CEO who is also a PhD-trained scientist, current green card regulations are so-called job killers and force many talented foreign nationals to return to their native countries to work with firms that directly compete with American life sciences companies. Unlike most of his peers, Lechleiter has been very outspoken about the lack of US life sciences innovation.

While Lechleiter comments may have been appropriate five or more years ago, they are no longer germane to America’s waning innovation in the life sciences. There is little doubt that many bright and talented foreign nationals were denied permanent residency during the Bush era (2000 to 2008) because of stringent immigration policies and limits on the numbers of green cards allotted for persons from certain parts of the world; mainly China, India and the Middle East. This, in turn, forced many life scientists—many of whom desperately wanted permanent residency in the US—to return to their home countries to look for work and gainful employment.

As Lechleiter rightly asserts, these scientists found work with companies that began to directly compete with US life sciences. This phenomenon, coupled with the rapid assent of the middle class in many of these nations, made it possible to begin to conduct Western style research at a much lower costs in these countries. To that end, by 2007, most big pharma companies—many of whom had dwindling pipelines and monstrous overhead costs—realized that it would be more cost effective to outsource or move R&D to countries with emerging pharmaceutical and biotechnology markets and a well trained R&D workforce. And, for the past four years downsizing and outsourcing of R&D are exactly what have been taking place at many American big pharma and biotechnology companies.

In my opinion, the larger question that must be addressed, as far as US innovation in the life sciences is concerned is: why are so few Americans willing to pursue scientific careers? To wit, the main reason why so many foreign life scientists were educated and trained in the US over the past 20 years was because there weren’t enough American students to fill the incoming roster at most American graduate training programs. Put simply, America’s growing lack of innovation in the life sciences over the past decade can be directly attributed to far fewer Americans pursuing scientific careers and an increased reliance on foreign nationals—who were unable to stay in the US—to innovate! While changing US immigration laws may allow some foreign nationals to more easily remain in the US, there simply aren’t enough life sciences jobs left in the US to make it worth their while! In fact, the likelihood of them finding life sciences jobs in their home countries is now greater than it is in the US. In my opinion, the only way to restore American innovation in the life sciences is to convince American students that pursuing scientific careers is worthwhile and that the requisite training for industry jobs is available to them.

Interestingly, after leading with changes to US immigration laws, Lechleiter also suggested that America’s innovation problem could be solved by lowering US corporate tax rates and American companies should not be forced to pay taxes on oversea earnings. Also, he asserted that the US Food and Drug Administration (FDA) should stop putting off decisions or erring on the side of avoiding risk when considering new drug applications. 

This begs the questions, how do lower taxes, no overseas taxes and expedited drug approvals help to spur American innovation when most life sciences R&D is conducted outside of the US?

Until next time...

Good Luck and Good Innovating!!!!!!!!

 

Why Transforming FDA Makes Sense

During the Bush Administration I, along with many others, was a harsh critic of the US Food and Drug Administration (FDA). The criticisms that I levied against the agency were mainly based on its inability to adequately maintain the safety of the American drug and food supply and Bush’s repeated attempts to politicize the organization and render it useless. That said, it is amazing how much has and will change at the agency during the Obama Administration. To wit, Margaret Hamburg, the current FDA Commissioner yesterday announced plans that would dramatically transform the agency and largely change the way it does business.

In an unusually rare special report entitled “Pathway to Global Product Safety and Quality” Hamburg points out the monitoring problems currently facing the agency and proposes a four-point plan on how to fix them. To understand the importance of this document it is necessary to point out some little know facts about the American food and drug supply.

First, almost two-thirds of all fruits and vegetables and nearly 75 percent of all seafood consumed by Americans is imported. This year the number of these types of food shipments is expected to grow to 24 million through 300 or more ports. A little as a decade ago, the agency was responsible for overseeing and policing six million shipments annually. Second, it is estimated that over 80 percent of the active pharmaceutical ingredients (APIs) found in approved drugs are made in manufacturing plants found mainly in China, India and Latin America. Because of funding and “manpower” shortages, most of these API manufacturing facilities are rarely inspected for regulatory compliance. According to the report, many kinds of antibiotics, oncology drug and other medications are no longer produced in the US or in many cases anywhere in the Western world. Finally, roughly 50 percent of all approved medical devices sold in the US are made in foreign production facilities.

In 2008, government officials determined that the agency would need approximately 13 years to inspect all foreign drug manufacturing plants, 27 years to check every foreign medical device production facility and a whopping 1,900 years to check every foreign food production plant! This is because FDA has only several hundred inspectors who are empowered to perform these inspections. Consequently, only a fraction of the food and APIs imported to the US are inspected. For example, less than one pound in a million of imported seafood gets as much as a “visual inspection” to determine whether or not it is fit for American consumption. This led the report’s authors to contend that “the safety of America’s food and medical products remain under serious threat.”

Yet, despite this ongoing threat, Republican lawmakers last week voted to cut the agency’s budget rather than increase it to perform the necessary number of food and drug inspections. Further, the same lawmakers oppose any corporate or consumer fees, whether voluntary or forced, to help to underwrite the inspections calling them an unacceptable tax. This has forced the agency to enlist the help of regulators in other nations to create a global coalition or network to perform the required inspections to insure the regulatory compliance and safety of foods, drugs and devices imported into the US. While the FDA has limited cooperation agreements with regulators in Europe and other Western countries, it just recently stationed its own inspectors in emerging markets like China, India and Central America. In theory this should work. However, in the past, some of the governments of these countries have refused to fully cooperation with FDA. Further, and perhaps more problematic, is that regulatory agencies in some other countries are largely corrupt or nonexistent. Finally, some outspoken former FDA employees and critics contend that improvements in the communication between FDA in Washington and its field offices in US states may be necessary before the agency can effectively enlist the cooperation of foreign regulators.

There is no doubt that contaminated foods, counterfeit medical devices and tainted drugs are increasingly finding their way into the US. It is FDA’s legislated responsibility to insure that all foods and drugs sold in the US are safe and effective for all Americans. Republican lawmaker’s refusal to increase FDA’s budget to allow the agency to fulfill its mandate is unconscionable and indefensible. The safety and health of all Americans is critically important for the well being of the nation and ought to take precedent over budget shortfalls and a looming US trade deficit.

Until next time...

Good Luck and Good Job Hunting!!!!!!

 

In Case You Haven't Been Paying Attention: The Indian and Chinese Life Sciences Markets Are Poised For Expansive Growth

Over the past week or so there have been daily snippets on various media platforms about business deals and opportunities in the Indian and Chinese life sciences market. While it is not news that many life sciences companies are expanding operations into these markets, the growing frequency of news items about the “goings on” in both markets are noteworthy.

The first bit of news that started the Indian and Chinese life sciences news avalanche, was a note on May 29 that appeared on The Economic Times’ website that reported that New Delhi-based JB Chemical and Pharmaceuticals planned to double the size of its medical sales reps to 1,500 over the next two years to increase its penetration into rural Indian markets. The company had previously divested it over-the-counter consumer business in Russia and other Commonwealth Independent States (CIS; composed of countries from the former Soviet Union) to start up new divisions in gynecology and dental products.

The same day, another New Delhi-based drugmaker called Lupin that specializes in generic drugs, announced that it plans to launch 50 new products by FY12; twelve of which will be generic drugs launched in the US. Both bits of information suggest that new previously untapped commercial opportunities are rapidly beginning to emerge in India and that Indian drug makers are looking to compete in the US and Western European markets that were previously dominated by American, Western European and Japanese companies.

In other India-related pharmaceutical news, an article appeared on June 2 at the Online Pharma Times website that reported that Shlomo Yanai, CEO of the Israeli generic pharmaceutical giant Teva, had flown to India to discuss potential collaborations with pharmaceutical companies there. While most analysts do not think that an acquisition is likely—Teva agreed to buy US-based Cephalon in May for $6.8 billion and also paid $460 million to acquire a controlling stake in Japanese generics group Taiyo Pharmaceuticals—it signals a growing interest by foreign companies to do deals in India to establish a presence it that market.

Like the Indian market, the Chinese market is beginning to heat up. An article at Bloomberg.com published on June 1 reported that Novo Nordisk will boosts its investment in China to preserve its dominance in the diabetes market after rival Sanofi announced a new foray into the Chinese market.

According to a report issued last fall by the International Market Analysis Research and Consulting Group, the Chinese diabetes market is expected to grow from $642 million in 2009 to more that $2.8 billion in 2015. The reason for the increase is attributed to the trend of more people moving from rural areas to cities and changes in eating habits and lifestyles that are contributing to a growing Chinese obesity problem. At present the US Centers for Disease Control in Atlanta estimates that roughly 8.3 percent of the U.S. population and 6.6 percent of the global population has diabetes

Novo first entered the Chinese market about 15 years ago and in 2002 created a diabetes research center and in 2007, in association with the Chinese Academy of Sciences established a foundation to fight diabetes. This year, the company plans on expanding its insulin packaging plant in China becoming the world’s largest insulin packaging facility.

Likewise, in 2005 Sanofi created a diabetes clinic. Three years later is expanded the clinics operations, established a clinical trial center and entered into a partnership with the Shanghai Institutes for Biological Sciences to develop treatments for diabetes, cancer and neurological diseases.

On Jun 3, Pfizer, the world’s largest drugmaker (for now) announced that it plans to partner in a joint venture with China’s Zhejian Hisun Pharmaceutical Company to produce generic drugs for the emerging Chinese market. According to the post on Bloomberg.com

“Pfizer is looking for new sources of revenue before it loses U.S. patent protection in November for Lipitor, the cholesterol medication that was the world’s best-selling drug last year with $10.7 billion in sales. Off-patent medicines, including branded generics, are one of the fastest growing segments in the global pharmaceutical market, Pfizer and Hisun said in a joint press release.”

At present, Pfizer is the top drug company in China (by sales) followed by AstraZeneca and Sanofi according to information supplied by the prescription drug intelligence firm IMS. The size of the Chinese drug market is project to grow by 25 percent this year and rough 60% of the existing market is dominated by generic drugs.

Finally, Chinese pharmaceutical companies are also beginning to invest in the US market. Late last week, the Tianjin Tasly Pharmaceutical Group signed an agreement with the State of Maryland to invest $40 million to build a tradition Chinese medicine (TCM) facility to provide TCM training and information. According to a press release:

“Tasly Pharmaceutical is currently preparing materials for approval by America’s Food and Drug Administration and plans to sell compound danshen drip pills in US and European markets. The medicine’s primary ingredient is obtained from the salvia miltiorrhiza species and is used to treat cardiovascular and cerebrovascular diseases. Danshen is also known colloquially as red sage or Chinese sage.”

I think it is time to pay more attentions to the ebb and flow of the Indian and Chinese markets!

Until next time,

Good Luck and Good Job Hunting (try India and China)!!!!!!

 

All Things Clinical

In case you may not have noticed, clinical research is one of the hottest new career tracks for medical and scientifically minded persons seeking employment in the life sciences industry.  To that end, Rick Malone, who blogs at the website Clinical Researchers posted a useful article entitled "40 Useful Reference Sites for Clinical Research."  The list is comprehensive and informative for those considering a career move into clinical research.

The blog is maintained by a group called Masters in Clinical Research, a website devoted to clinical research training and degree programs in clinical research.

For those of you who are tired of benchwork, clinical research and clinical trials management may be a career option to consider!

Until next time....

Good Luck and Good Job Hunting!!!!!!!

 

More Evidence That Big Pharma's Investment in R&D Will Continue to Wane

There is no longer any doubt that big pharma companies are beginning to reduce their emphasis on internal R&D activities. Instead the companies will increasingly rely on outsourcing, partnerships, closer collaborations with academia, public private partnerships and M&A to keep their drug development pipelines full

Therefore it was not surprising when Merck’s new CEO, Kenneth Frazier recently mentioned in a conference call to financial analysts and investors that its multi-billion spending on new drug R & D will likely decline as a percentage of overall sales in the coming years. Merck is one of the largest pharmaceutical companies in the world

According to an article on Nasdaq.com, in 2010, Merck spent $11 billion on R&D, or 24% of total sales. Adjusted to exclude certain acquisition-related and other costs, R&D spending was $8.1 billion. Merck has predicted 2011 adjusted R&D spending would be $8.1 billion to $8.5 billion for 2011.

Frazier, the first African American CEO of a major pharmaceutical company, came under pressure earlier this year after he decided to not substantially cut R&D as many of Merck’s rivals, most notably Pfizer, did. He noted that cuts in R&D spending would have jeopardized Merck’s long term product development pipeline.

While rumors persist that Merck may be seeking to jettison its non-pharmaceutical consumer health and animal health businesses, Frazier insisted that the two units are complementary to its core pharmaceutical and vaccine focus and are not for sale. That said, if I was a Merck employee in either of those divisions, I would be updating my resume just about now.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

 

What's Up At Bayer Healthcare?

Several weeks ago Bayer AG’s Chief Executive Officer Marijn Dekkers said that he would consider a “merger of equals” to bolster the company’s sagging healthcare division. The division, a minor revenue source for Bayer AG, posted $25.1 billion in sales last year.

Today, the company announced that by 2013 it would outsource the entire production of its blockbuster MS treatment Betaferon to its German arch rival Boehringer Ingelheim. At present, Betaferon sold in the US is manufactured at Bayer’s production facility in Emeryville, CA. Bayer will close that facility and about 540 jobs will be lost.

Boehringer already manufactures Betaferon sold in Europe and it recently received US Food and Drug Administration approval to also sell it in the US. A Bayer spokesperson said that “It is important for us that we can offer the product from a single source.” While that makes sense from a regulatory standpoint, the decision also suggests that Bayer Healthcare may indeed be positioning itself for sale. It also suggests that Bayer may be abandoning the US market for “greener pastures” in the emerging BRIC markets (Brazil, Russia, India and China).

For more insights into Bayer Healthcare check us this article in Life Science Leader.

Until next time...

Good Luck and Good Job Hunting!!!!!!!

 

The Rumor Mill: Is Cubist Really In Play?

For the past several days, the rumor mill has been rampant with suggestions that UK-based Shire may acquire Cubist, a publicly traded Massachusetts-based biotechnology company that sells Cubicin, an antibiotic indicated for the treatment of certain infections caused by methicillin-resistant Staphylococcus aureus (MRSA).

Rumor has it that Shire approached Cubist about a month ago with a $44.5-a-share proposal ($2.0 billion) and the pair have been in talks about a deal ever since. Last week, Shire announced that it had entered into a deal to acquire private-held Advanced BioHealing for $750 million. Connecticut-based Advanced BioHealing markets and develops products to enhance wound healing and treat diabetic foot infections in patients with diabetes. Shire’s acquisition of both companies would provide it with a substantial US presence in the antibacterial treatment and diabetes markets.

While Cubist may be a good “fit” for Shire, it is not clear whether or not the company will prevail in its takeover bid. Last month, Cubist settled a patent dispute Teva Pharmaceuticals over Cubicin, which lessened the threat of generic competition by the Israeli drug maker. This sparked speculation among a number of Wall Street analysts that other pharmaceutical companies including AstraZeneca and Johnson & Johnson who are themselves facing generic competition, may consider acquiring Cubist in an attempt to add new antibiotics to their antibacterial portfolios. 

This is not the first time that analysts have speculated that Cubicin may be ripe for acquisition. Almost two years ago, word-on-the-street had it that Novartis may acquire the company. Nevertheless, Cubist is one of the few remaining publicly-traded biotechnology companies that specialize in new antibacterial drug discovery. Its potential acquisition by a big pharma company may signal the end of innovative drug discovery in the antibiotics discovery space. Here’s hoping that Cubist remains independent!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

 

Pharmaceutical Direct-to-Consumer (DTC) Advertising Goes Mobile

While big pharma continues to struggle with the use of social media to promote its products, direct-to-consumer advertising (DTC), the method of choice for American pharmaceutical advertising is alive, well and robust. Therefore, it should come as no surprise that big pharma is reallocating some its traditional DTC advertising dollars to deliver drug ads to mobile devices which are growing in popularity. 

According to a recent article posted on PharmaLive, drug companies are mainly using mobile devices —in addition to delivering ads—to “help educate patients and motivate them to seek, accept, and adhere to therapy.” In other words, to more effectively promote their products to improve sales and corporate profits. Regardless of the motive, medical communication agencies have recognized the trend and have responded by launching mobile divisions and initiatives at their firms. Some agencies are now generating close to 50% of their revenues from mobile initiatives and campaigns. Further, many pharmaceutical companies have finally realized that corporate websites can be more than simple placeholders on the Internet. To that end, the PharmaLive post notes that pharmaceutical brand websites are evolving into a robust resource structured to be easily searchable and maintained. Maybe a better understanding and use of social media is next up for drug makers.

Pfizer remains the leading spender and purveyor of DTC advertising despite a 15% overall decrease in 2010 as compared with 2009. PharmLive reports that the company allocated $903.8 million to brands such as Lipitor, Pristiq, Viagra, Chantix, and Lyrica. Of these brands, Pristiq saw the highest increase of DTC advertising in 2010, up 17% to $122.2 million compared to 2009.

As mobile media continues to grow, don’t be surprised if someone develops a TIVO-like fast forward app to skip all of the DTC ads on your iPhone or android devices.

Until next time..

Good Luck and Good Job Hunting!!!!!

 

The Life Sciences Industry Continues to Get Smaller

Shire, an Irish speciality pharma and rare diseases drug maker, today announced that it would purchase Connecticut-based Advanced BioHealing (AB) for $750 million in an all cash deal. 

The main reason for the deal was AB’s Dermograft, a regenerative bio-engineered skin substitute used for the treatment of diabetic foot ulcers (DFU). Dermagraft currently has roughly a 5 percent share of the potential $3 billion slow-healing DFU market, approximately $146 million in US sales last year, and Shire says the potential for growth in the DFU market is considerable. Also, AB had finished enrolling patients into multinational trials to investigate Dermagraft for the treatment of venous leg ulcers. If all goes as planned, a regulatory filling in the USA for the new indication is planned for the first quarter of 2012.

Shire tendered its offer to purchase Advanced BioHealing one day before the company was to launch an initial public offering of 13.4 million shares priced from $14 to $16. The IPO would have raised over $200 million and the company would have been valued at around $630 million. The deal was a strategic move for Shire that wants to expand its product offerings in the speciality pharma sector. It isn’t clear whether the acquisition will result in layoffs at AB. Unfortunately, all cash transaction typically do not bode well for the company this is being acquired.

In other news, Takeda, after denying reports earlier in the week that it intended to purchase Nycomed for $12.0 billion is expected to announce the deal today.

Until next time...

Good Luck and Good Job Hunting!!!!!!

Addendum: At the press conference this afternoon, Takeda tersely stated that it had not agree to purchase Switzerland's Nycomed. Stay tuned for the next installment of the saga!

Addendum to the Addendum: Takeda Pharmaceuticals and Nycomed  jointly announced today that Takeda has reached an agreement with the shareholders of Nycomed in which Takeda will acquire the Zurich-headquartered company for $13.6 billion ( 9.6 billion Euro) on a cash-free, debt-free basis. The boards of directors of each company unanimously approved the transaction which is expected to be completed within 90 to 120 days, making it a wholly owned subsidiary of Takeda, subject to antitrust clearance. The purchase would exclude Nycomed's U.S. dermatology business.

Vaccines: The New Blockbusters?

Not too long ago, the mere mention of the word “vaccine” caused most big pharma executives to break out into a cold sweat. Once derided as low margin products and potential market busters—once most populations are immunized the incidence of disease declines and the market begins to falter—vaccines, primarily pediatric ones, have made a huge comeback over the last five years. 

One of the main reasons for the resurgence of the vaccine industry, was passage of US legislation that better-defined the legal obligations of vaccine makers and inclusion in the legislation of provisions that cap the size of awards made to persons claiming injury after vaccination. Another factor that contributed to the growing popularity of vaccines was emergence of the middle class in vast and concomitant improves in the healthcare systems of emerging markets that include South America, Asia and Africa. Unlike the mature vaccine markets in the US, Europe and Japan (because of low birthrates), the Asian, Latin American and African markets are poised for explosive growth over the next two decades.

In a recent article entitled “Vaccines-The Sustainable Blockbuster Business” Frost and Sullivan’s Senior Healthcare Analyst Barath Shankar Subramanian provides some interesting and insightful factoids about the vaccine industry. They are:

Pediatric vaccines are leading adult vaccines and represent the fastest growing segment of the global vaccine market

Europe is the world’s leading vaccine producer with over 90% of total production

The top five vaccine manufacturers (all big pharma companies) produce more than four-fifths of global vaccine revenues while other manufacturers (approximately 40) account for only one-fifth.

The North American market accounts for over 50 percent of the total spend on vaccines

North America and Europe supply only 14 percent of the world’s vaccine demand; the rest is met by suppliers in developing markets

Government investment, not-for-profit spending and industry alliances/ partnerships, in addition to private R&D spending, are helping to drive the current resurgence of the global vaccine industry

At present, there no fewer than 80 new candidates in late stage clinical development. Further, almost 40 per cent of the new vaccine candidates are for indications that currently have no vaccines on the market.  Finally, improvements in vaccine delivery are helping to drive the improved uptake of vaccines. For example, aerosols, transdermal skin patches, oral drops and even pills—all designed to eliminate needles and improve patient compliance and overcome cold chain supply issues are currently being developed.

From a business perspective—as far as sustainable markets go—the pediatric segment of the vaccine market is a clear winner. Currently, the leading global causes of vaccine-preventable, deaths for children under five include: pneumococcal disease, rotavirus, measles, Hemophilus influenzae b (Hib) infections, pertussis and tetanus. To that end, it is likely that governments in emerging markets will continue to add existing and new vaccines to government-mandated immunization programs. This is almost certain to propel the vaccine market to new heights over the next 10 years or more.

Until next time...

Good Luck and Good Job Hunting (think biologics!)

 

Antibiotic Revenues and Antibacterial Drug Discovery Research Are Declining

The loss of patent protection and a decline in revenues for a number of blockbuster brand name antibiotics has caused many big pharmaceutical companies to exit the antibacterial drug discovery market. The three remaining big pharma companies still actively engaged in antibacterial research are GlaxoSmithKline, AstraZeneca and Novartis (all European owned companies).

A new report by UK-based Datamonitor entitled “Forecast Insight: Antibacterials” predicts that antibiotic sales revenues will decline from $19.6 billion in 2009 to about $16.4 billion in 2019. Not surprisingly, the report blames the projected decline on generic competition and the lack of new antibiotic launches over the past 10 years.

At present, the top seven antibiotic markets in the world include the US, Japan, France, Germany, Italy, Spain and the UK. According to Datamonitor’s analyses, total sales in these markets have fallen by about 1.6 percent annually since 2005 and will continue to decline by almost 2.0 percent a year through 2019. In 2009, three antibiotics had sales of about or more than $1.0 billion; Johnson & Johnson’s Levaquin (market leader), and Pfizer’s Zosyn, and Zyvox. Interestingly, Pfizer recently decided to shut down its US-based antibacterial drug discovery program and move it to China and Johnson & Johnson recently announced that it was getting out of the antibiotic discovery business

Big pharma’s decision to abandon antibiotic research could not have come at a worse time. The incidence of antibiotic resistance among both Gram positive and Gram negative bacteria is rising at unprecedented rates. And while safe and effective treatments for Gram positive infections including MRSA (methicillin-resistant Staphylococcus aureus) still exist, the number of treatment options to treat Gram negative infections caused by Acinetobacter spp, Pseudomonas aeruginosa and enteric bacteria is severely limited. The recent description and rapid spread of a beta-lactamase enzyme called NDM-1 that inactivates the antibiotic carbapenem—the last safe and effective antibiotic to universally treat infections caused by Gram negative bacteria —is extremely troubling and worrisome.

While much of the focus over the last decade was on MRSA, infections caused by untreatable, multiple drug resistant Gram negative bacteria will pose the greatest public health threat over the next 10 years. Unfortunately, it is much harder to develop new antibiotic treatments for Gram negative infections as compared with ones caused by Gram positive bacteria. Further, at present, most of the companies that remain in the antibiotic space continue to focus on new treatment for MRSA and related bacteria. Consequently, new treatments for Gram negative infections may be more than a decade away!

Finally, like MRSA, most infections caused by multiple drug resistant Gram negative bacteria are nosocomial in nature (although the incidence of community acquired infections is also on the rise). This means that the most likely place to become infected with these bacteria is institutionalized healthcare settings including hospitals and nursing homes.

In the past, we have relied on pharmaceutical and biotechnology companies to discover new antibiotic treatments. The decision of many of these companies to leave the antibacterial space for purely financial reasons is unfortunate and regrettable. However, the growing incidence of antibiotic resistance among both Gram positive and Gram negative bacteria suggests that new antibiotics are necessary and that alternate approaches to new antibiotic drug discovery must be implemented. Whether this is through public/private partnerships or strictly through government programs is irrelevant. The bottom line is that we need new antibiotics; and if they are not discovered soon, many patients will die from previously treatable bacterial infections!

Until next time...

Good Luck and Good Job Hunting (start an antibiotic drug discovery company)

 

Takeda Pharmaceutical Company Continues Its Westward Expansion

Takeda Pharmaceutical Company, Japan’s largest pharmaceutical company, yesterday announced its intention to purchase the Swiss drug maker Nycomed for 8 to 10 billion euros ($11.4-14 billion). While the deal is not certain to close, it signals Takeda’s intention to purchase its way into the US and European markets.

Takeda acquired Cambridge, MA-based Millennium Pharmaceuticals in 2008 for $8.8 billion, the largest foreign acquisition ever by a Japanese company. The Millennium acquisition was intended to bolster Takeda’s competencies in genomics and oncology drug discovery. If Takeda is successful in its bid, Nycomed would enhance the company’s standing in treatments for gastric, respiratory and inflammatory disorders. Nycomed has operations in roughly 70 countries, with Europe representing 50 percent of the company’s sale and emerging markets 38 percent.

Takeda’s chief executive officer Yasuchika Hasegawa has pursued an aggressive M&A strategy since assuming control of the company in 2003. Historically, Japanese drugmakers intentionally remained small and were content doing business in local and other Asian markets. However, Hasegawa has changed the “game” and has forced some of Takeda’s rivals to emulate his global strategy. To that end, in recent years Daiichi Sankyo Company has purchased Plexxikon and Ranbaxy and Astellas acquired OSI pharmaceuticals as part of a westward expansion.

While Takeda remains Japan’s largest pharmaceutical company, net profit slumped 17 percent last year and the company is losing patent protection for its largest selling drugs, Prevacid (ulcers) and Actos (diabetes). Like Takeda, Nycomed sales are being hit by the loss of patent protection for its largest selling drug Protonix (antacid). Worldwide sales of the drug plummeted by almost 28 percent. Therefore, it would appear that Takeda’s pursuit of Nycomed is based more on its pipeline rather than currently marketed products.

Stay tuned for late-breaking news on the deal!

Until next time,

Good Luck and Good Job Hunting!!!!!

 

Calling All Life Sciences Startups: Check out LifeScienceFest Americas if Your Company is looking for Investment Capital

After a long drought, venture capital and private equity investments into private life sciences companies are beginning to flow again. VCs and fund managers have monies that must be invested into promising new ventures. The best way to find the right investors is to present at life sciences investment fairs like LifeScienceFest Americas. This year BioJobBlog and BioCrowd are cosponsoring the event.  

If you are interested in presenting your company to qualified investors, please read the information presented below and take advantage of discounted rates.

APPLY NOW TO PRESENT AT LIFESCIENCEFEST AMERICAS - JUNE 17, 2011
Investorfest Media is proud to announce call for nominations from promising startups for
LifeScienceFest Americas conference on June 17th.  At the 3rd annual venture conference, we will showcase up to 16 promising innovators seeking funding to active life science angels and investors.

APPLICATION DEADLINE : MAY 14, 2011
If you are a startup (seed, Series-A,B,C or restart) from the medical device, diagnostic or
healthcare technology space and you are seeking new investment to start or grow to the
next level, this is THE conference for you. You must be seeking funding from $250K to
under $20M. Learn more on the application process, segments of interest and deadlines.

CONNECT WITH LEADING INVESTORS AT LIFESCIENCEFEST
General Partners & angels from 20+ leading firms including Sand Hill Angels, Band of Angels, Keiretsu Forum, Claremont Creek Ventures, Bay City Capital,Physic Ventures, Psilos Ventures, Sofinnova Ventures,  Lumira Capital and many others will be at the event. Learn more..

WHO SHOULD ATTEND

Investors from Founders of promising innovative companies seeking capital to industry executives, investors and M&A professionals will be in attendance at this exclusive, limited seating event. Non-presenting entrepreneurs can also attend, and must register early to reserve their spot. Register Now to reserve your spot

BIOJOBBLOG BIOCROWD MEMBER DISCOUNT
A limited number of discounted tickets are available for Biocrowd members who will receive $50 off early bird registration and pay just $299. Apply code BIOCR50. Discounts are offered to qualified non-service provider professionals from the life science and med device industry and on a first-come, first-serve basis. Register Now at the discounted rate.

ABOUT INVESTORFEST MEDIA
Investorfest Media is the leading VC funding accelerator working in the life science and medical device space. Through our highly focused training and hands on support, qualified companies are put in front of specially chosen investors our annual LifeScienceFest conference. To date over 75% of presenting companies have gone on to receive funding, with over $280 million being raised since 2006. Learn more at investorfest.com

Until next time

Good Luck and Good VC Hunting!!!!!!

 

Human Clinical Trials Go Global

The clinical trial phase of the drug development process is labor intensive, costly and usually takes the largest amount of time to complete. In the past, most human clinical trials for new molecular entities discovered by American scientists were conducted in the US. However, growing healthcare costs and shortages of “treatment-naive” trial participants have forced drug makers to take the effort global. To that end, many companies now routinely conduct Phase I (safety) and Phase II (proof of principle) trials in Eastern Europe, Latin America and Asia. Moreover, a growing number of pharmaceutical companies are beginning to conduct pivotal Phase III trials in which a majority of participants come from outside of the US.

Last year, a report from the inspector general of the Department of Health and Human Services revealed that in 2008 a whopping 78 percent of all subjects participating in trials to support drug applications submitted to the US Food and Drug Administration were enrolled in foreign sites. Likewise, in Europe, approximately 61 percent of patients in human trials submitted to the European Medicines Agency (EMA) from 2005-2009 were from developing countries. Additionally, 11 percent of the participants were enrolled in studies conducted in Eastern Europe. Poland and Hungary appear to have benefited the most from this trend; the number of Poles involved in trials rose fivefold over the period while Hungary was up almost fourfold.

According to a recent article from Reuters, ClinicalTrials.gov—a public website managed by the National Institutes of Health that tracks current US clinical trials—lists roughly 106,000 human clinical trials that are underway around the world. Approximately 50 percent of these trials are being conducted in the US. Interestingly, at present, only 43 percent of all pivotal Phase III trials are being conducted in the US.  Not surprisingly, China is the beneficiary of the trend and is experiencing exponential growth in the number of clinical trials conducted within its borders. To date, over 2,700 clinical trials have been performed in China and that number is likely to drastically increase over the next five years as Chinese medical and healthcare infrastructure continue to improve.

While outsourcing human clinical trials may be favorable to drug makers, the trend is beginning to anger many American physicians who previously benefited from managing US-based clinical trials. These physicians blame their misfortune on the life sciences industry’s endless pursuit to lower costs and the increasing regulatory bureaucracy and red tape surrounding clinical trial procedures in the US.

In addition to physician anger, outsourcing human clinical trials poses several other problems. First, there is a question of ethics. For example, is it right to test an expensive new drug in a country where locals may never be able to afford it if approved? And, are foreign patients always adequately informed or educated about the potential risks and side effects associated with experimental medicines? Second, can ethnic differences between patients contribute to differences in drug effectiveness and safety? In other words, will Caucasian patients respond to a new drug in the same ways as Asian patients? Finally, in the absence of rigorous regulatory inspections can Good Clinical Practices be routinely maintained across all global clinical trial sites? To that end, as pointed out in the Reuters article from 2005 to 2009 EMA inspectors only conducted 44 good clinical practice inspections (outside of the US and Europe) from a total of 44,034 clinical sites. Meanwhile, during the same period, the US FDA inspected only 0.7 percent of foreign clinical trial sites as compared with 1.9 percent of domestic sites.

Like it or not, outsourcing of human clinical trials in emerging markets is a trend that is likely here to stay. Hopefully, in the future, regulatory agencies will be able to better oversee foreign human clinical trials to insure that the drugs that they approve continue to be safe and efficacious.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!

 

Brand Management: Sanofi-Aventis Shortens Its Name!

In the play Romeo and Juliet, William Shakespeare famously wrote:

"What’s in a name? that which we call a rose

By any other name would smell as sweet ..."

While I am not so sure about the “sweet part,”  French pharmaceutical giant Sanofi-Aventis believes that no matter what it calls itself it will still be the same old company. To that end, Sanofi-Aventis last Friday announced that it will officially shorten its name to simply “Sanofi.” 

Sanofi is one of the world’s largest pharmaceutical companies based on revenues. It was formed in 2004 in a merger between two French pharmaceutical companies, Sanofi-Synthelabo and Aventis. The reason for the name change; most people (me included) simply called it Sanofi rather than Sanofi-Aventis. And, perhaps more appropriately, the company wanted its name to be “recognizable and easy to pronounce” around the world.

In addition to the name change, the company also declared a dividend of 2.50 euro for its shareholders that will be paid either in cash or stock. The dividend payout will take effect by June 16, 2011

As you may recall, Sanofi purchased Genzyme last month in a $20.1 billion deal. Perhaps the name change was announced because Sanofi-Genzyme is much easier to pronounce and has a better “ring to it” than Sanofi-Aventis-Genzyme?

Until next time...

Good Luck and Good Job Hunting!!!

 

Bayer CEO: "Make Me An Offer!"

Bloomberg news today reported that Bayer AG’s Chief Executive Officer Marijn Dekkers said that he would consider a “merger of equals” to bolster the company’s sagging healthcare division. The division, a minor revenue source for Bayer AG, posted $25.1 billion in sales last year.

While Dekkers did not name the companies that he considers to be Bayer’s “equals”, convention wisdom suggests the list is likely to include Eli Lilly & Co, Bristol Myers Squibb (BMS) and Amgen, one of the last remaining, large, independent biotechnology companies. Lilly and BMS both  had  sales revenue similar to Bayer's last year whereas Amgen had lower sales of $15.1 billion. 

The reasons for a potential merger are not entirely clear. However, Bayer Healthcare is waiting to hear about regulatory approval of its new anticoagulant Xarelto medicine for irregular heartbeat patients who face the risk of a stroke. Analysts predict that Xarelto may exceed $2.5 billion in global sales. Approval of Xarelto will change Bayer’s valuation and consequently, don’t expect merger talks to begin until after FDA renders its decision on the drug.

Meanwhile, Bayer’s top-selling multiple sclerosis (MS) treatment betaseron faces competition from a similar Novartis drug called Extavia, and from its new oral MS medication Gilenya. Sales of betaseron fell 5 percent in the first quarter. Moreover, sales of Bayer’s birth-control pill Yaz dropped 18 percent after Teva Pharmaceutical Industries Ltd. introduced a generic version of the medicine.

Lilly, BMS and Amgen all face significant challenges in the future and both BMS and Amgen have been repeatedly mentioned as takeover targets. However, from a historical perspective mergers of mediocre or struggling companies rarely yield stronger, more financially robust ones! But, what do I know, I am just a scientist!

Stayed tuned for more updates.

Until next time...

Good Luck and Good Job Hunting!!!!!!!

 

Consolidation Continues in the Pharmaceutical Sector: Teva to Acquire Cephalon for $6.8 Billion

The world’s largest generic pharmaceutical company Teva Pharmaceuticals Industries LTD today announced that it has agreed to purchase Pennsylvania-based Cephalon, Inc for $6.8 billion. Teva will purchase Cephalon for $81.50 per share, a 12 percent premium to the $73-per share unsolicited offer tendered by Valeant Pharmaceuticals International Inc, on March 29, 2011. Cephalon’s board of directors rejected Valeant’s offer on April 5, 2011.

While most of Teva’s revenue comes from the sale of prescription generic medications, the company also sells several branded pharmaceutical products including the multiple sclerosis drug Copaxone and the Parkinson’s disease Azilect. Cephalon’s best selling drugs include Provigil for narcolepsy and the cancer drug Treanda. In addition to its marketed products, the Cephalon development pipeline contains potential cancer treatments, a tamper-resistant opioid painkiller, and an asthma treatment. The Cephalon acquisition is a pivotal part of Teva's strategy of growing branded drug revenue to $9 billion by 2015.

Teva currently has about 40,000 employees worldwide while Cephalon employs 4,000 persons. It is not clear what ever the acquisition will have on job layoffs or organizational structure.

Cephalon’s stock price rose $3.25 or 4.2 percent to $80.26 after the deal was announced.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!!

 

The Hidden Costs Of Prescription Drug Development That Nobody Likes To Talk About!

Depending upon the source, the cost of bringing a new prescription drug to market these days ranges from roughly $1.2 to 1.5 billion. While there is no question that clinical studies represent the most costly aspect of getting new drugs approved, the hidden costs—mainly promotion and marketing—are what actually inflate the costs of new drug development. Not surprisingly, drugmakers fail to disclose that these costs are included in the estimates for new drug development. If these costs were eliminated from the total, then the cost of developing new drugs will be significantly less than the current $1.2 to $1.5 billion price tag.

I suspect that many BioJobBlog readers—mainly those who work in the drug industry—will likely write me off as someone who doesn’t know what he is talking about. But, an interesting tidbit that I found in an article in today’s New York Times entitled “A Fight Over How Drugs are Pitched” suggests that my claims ought not be summarily dismissed simply because I am a “left-leaning histrionic democrat.” To wit, according to IMS Health (a competitive intelligence firm that tracks physician prescription rates) in 2009 alone, the branded prescription drug industry spent about $6.3 billion on marketing visits to doctors! This amount does not include costs associated with marketing and advertising that support direct-to-consumer (DTC) advertising campaigns that are run by companies that sell approved prescription drugs. DTC costs are generally much higher than those spent on direct marketing to physicians.

It is important to remember that a drug maker’s main goal is to convince physicians to prescribe “their” drugs. After all, physicians not patients write prescriptions! That said, physician prescribing behaviors are vitally important to the success or failure of a marketed prescription drug. Consequently, it should come as no surprise that marketing costs are factored into the cost associated with new drug development. Obviously, if less money was spent on marketing than the cost of bringing new drugs to market would likely be substantially less.

Interestingly, the States of Vermont, New Hampshire and Maine recently enacted laws to limit the uses of a doctor’s prescription records for marketing. On Tuesday, the US Supreme Court will hear arguments in a case, Sorrell v. IMS Health that tests whether Vermont’s prescription confidentiality law violates the free speech protections of the First Amendment. The federal government, the attorneys general of several dozen states, AARP, professional medical associations, privacy groups and the New England Journal of Medicine have filed briefs in support of Vermont’s law. The National Association of Chain Drugstores, the Association of National Advertisers and news organizations like Bloomberg and The Associated Press have filed briefs aligning themselves with the data firm.

Although a Vermont federal district court upheld the law after a lawsuit challenging the statute brought by IMS Health and the Pharmaceutical Research and Manufacturers of America, an appellate court overturned the decision suggesting that it violates free speech provisions afforded by the First Amendment of the US constitution.

It will be interesting to see how the “Supremes” adjudicate the appeal given the growing recognition that laws and regulations designed to control medical costs and minimize safety risks associated with newly approved drugs are becoming increasingly necessary.

Until next time...

Good Luck and Good Job Hunting!!!!!!!

 

Antimicrobial Nanoparticles and Mercury-Methylating Desulfovibrio

On episode #5 of the podcast This Week in Microbiology, Vincent, Cliff, Michael and Ron discuss the genome sequence of a mercury-methylating bacterium and the antimicrobial effects of nanoparticles on polar soil microflora.

Right click to download TWiM #5 (52.5 MB .mp3, 76 minutes).

Subscribe to TWiM (free) on iTunesZune Marketplace, via RSS feed, by email or listen on your mobile device with the Microbeworld app.

Image of Biofilm of Desulfovibrio desulfuricans by PNNL - Pacific Northwest National Laboratory via flickr

Links for this episode:

Send your microbiology questions and comments (email or mp3 file) to twim@twiv.tv , or call them in to 908-312-0760. You can also post articles that you would like us to discuss at microbeworld.org and tag them with twim.

 Until next time...

Good Luck and Good Listening (to TWiM)

Looking Back: The Largest Big Pharma Drug Settlements in the Past Two Years

Big pharma continues to lament the increased scrutiny being imposed on it by the US Food and Drug Administration (FDA). Like it or not, the agency’s directive is to insure that the drugs that it approves are safe and effective for the American public. And, for the most part, the agency does its job and frequently catches companies that attempt to break the rules.

To that end, an article that appeared in FiercePharma last October noted that eleven big pharma companies had paid a total of over $6.0 billion in fines to the US government over the last two years or so. The biggest losers include Eli Lilly paid over $1.4 billion in fines because of alleged illegal marketing of its anti-psychotic drug Zyprexa and Pfizer which paid $2.3 billion for marketing missteps with three drugs including Bextra (pain), Geodon (schizophrenia) , Lyrica (neuropathic pain) and Zyvox (antibiotic). 

More recently, GlaxoSmithKline agreed to pay $750 million fine in a whistle blower lawsuit that alleged that the company had sold "adulterated products" manufactured in a Cidra Puerto Rico production facility. Also, the company announced last February that it intends to pay $3.4 billion to settle lawsuits alleging the improper promotion and sale of several of its products including the blockbuster diabetes drug Avandia and Paxil (depression).

The article also included a timeline of some of the other major settlements that have recently taken place (seen below)

Novartis
With: U.S. Attorney's office for the Eastern District of Pennsylvania
When: Sept. 30, 2010
Infraction: Novartis agreed to a $422.5 million settlement with the Eastern District of Pennsylvania for its off-label promotion of Trileptal and other allegations against Diovan, Exforge, Sandostatin, Tekturna and Zelnorm.

Forest Labs
With: Dept. of Justice
When: Sept. 15, 2010
Infraction: After marketing Levothroid, an unapproved thyroid drug, Forest Labs received its penalty, to the tune of $313 million. The settlement also covered Forest's off-label use of Celexa for children's use.

Allergan
With: Dept. of Justice
When: Sept. 1, 2010
Infractions: Allergan's $600 million Department of Justice settlement was broken into two parts: $375 million in fines and $225 million in civil penalties, all of which stemmed from its off-label use of Botox for headaches, pain management and cerebral palsy.

Elan
With: U.S. Attorney's Office in Massachusetts
When: July 15, 2010
Infraction: The Irish drugmakers received its $203.5 million fine for its marketing tactics of Zonegran, an epilepsy drug. Also, the company's U.S. branch pled guilty to a misdemeanor and the company will enter into a corporate integrity agreement with the HHS Inspector General.

Johnson & Johnson
With: Department of Justice
When: April 29, 2010
Infraction: Though J&J's more infamous woes stem from its phantom recalls, two of the troubled drug maker’s subsidiaries received a $81 million penalty for off-label promotions of Topamax, an epilepsy drug.

AstraZeneca
With: U.S. Attorney's office in Philadelphia
When: April 27, 2010
Infraction: In the same week as the J&J settlement, AstraZeneca was hit with a $520 million penalty for its antipsychotic, Seroquel. The company misled doctors and patients about the drug's safety.

Despite concerted efforts by the US Food and Drug Agency to limit off-label promotion of prescription drugs, most pharma companies continue to see how far they can push the envelope before the agency catches up with them. Given the current budget woes facing FDA, don’t be surprised if the frequency of off label promotion and misrepresentation of prescriptions drugs continue to rise.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!
 

 

Pharmaceutical R&D Continues Its Eastward Migration

For the past three years or so, Eli Lilly CEO John Lechleiter has publicly criticized America’s lack of math, science and engineering preparedness. Further, he has lamented that this lack of preparedness has resulted in a lack of innovation and that it threatens the US standing as a leader in the pharmaceutical and biotechnology industries. Finally, Lechleiter squarely places the blame on American science educators. 

Therefore, it came as somewhat of surprise to me when I learned that Lilly (and many other pharmaceutical companies) are outsourcing an increasing amounts of drug discovery and development to Chinese contract research organizations (CROs pharma companies continue to outsource drug R&D to ostensibly lower development costs and get drugs to market faster. According to Chuan “Joe” Shih, a former Eli Lilly employee of 25 years and executive vice president of integrated drug discovery at Crown Bioscience a Shanghai-based CRO, the total annual cost for one researcher at Lilly might run $300,000 to $350,000 a year. The figure at Crown is one-third of that. Shih also disclosed that Pfizer was one of Crown’s clients.

In addition to Crown, Eli Lilly has outsourced R&D to other Chinese CROs that includeWuXi AppTec and ChemExplorer. It also operates its own research-and-development center in Shanghai and is building a diabetes research center here. Like Lilly, big pharma companies like Roche, Novartis and others have also established research centers in China.

Some analysts contend that the reasons given for the current R&D outsourcing trends—lower costs and faster market times—are red herrings. They suggest that establishing R&D in China helps position companies to sell into the huge, emerging Chinese market. Within the next decade or so, the Chinese market may eclipse the US as the major pharmaceutical market in the world.

Interestingly, in an interview in Shanghai Lilly’s Lechleiter said that he believed that CROs in China have more to offer than cost savings. “The skill level and the quality and the increasing availability of high-skilled and high-quality operations in the contract-research space render these firms globally competitive,” he said. Further, he added that in recent years, Lilly has had difficulty getting green cards or permanent resident visas for some of the Chinese people graduating from American universities it wants to hire. “So we need to follow the talent, and I expect there will be people recruited to the U.S. who will want to stay in the U.S. And there will be Chinese people and others who want to come back here. Our research center in Shanghai gives them a place to land.”

Does this mean that Lechleiter has given up on his quest to improve American science preparedness and American innovation? And, what will become of the 100,000 or so American pharmaceutical scientists who were laid off in recent years or those new minted American PhDs who cannot find work in the US? Is that the fault of the American education system or pharmaceutical companies that are trying to maintain profit margins at any cost or improving the likelihood of success in emerging markets in developing nations?

Until next time…

Good Look and Good Job Hunting (try the BRIC countries)

 

Is Latin American The Next Big Market?

While India and China have been getting much of the attention and press over the past few years, Latin America is quietly become a market to watch for the life sciences industry.  According to industry analysts,the Brazilian pharmaceutical market has been growing at a rate of about 12 percent per year and is expected to be the world's fifth-largest pharmaceutical market by 2015.

A number of companies have been doing deal in Latin America mainly in Mexico and Brazil. Late last week, Amgen announced that it had purchased the privately-held Brazilian company Bergamo for about $215 million. As part of the transaction Amgen had reacquired marketing rights in the country to several Amgen products. Also, Amgen also agreed with Hypermarcas, a maker of personal hygiene products, to reacquire Brazilian rights to several products, including its Vectibix cancer drug.

Bergamo, which had $80 million in revenue last year, supplies medicines to the Brazilian hospital sector and has capabilities in oncology. Amgen, which is acting more and more like a pharmaceutical company rather than a biotechnology company, has clearly signaled its intention to take advantage of opportunities in emerging markets in BRIC (Brazil, China, India and China) counties.

Amgen has been struggling of late and its drug development pipeline, like many of its pharmaceutical rivals, has grown thin over the past decade.  Don't be surprised if Amgen is the next biotechnology company to be purchased by a big pharma company.  Merck's intention to enter into the biosimilar and biomanufacturing sectors suggest that Merck may be a likely suitor to gain control of the EPO and Neupogen franchises as well as Amgen's stake in the Enbrel market.

Until next time...

Good Luck and Good Job Hunting (try Brazil)

 

More M&A in the Life Sciences Sector: Valeant Pharmaceuticals Attempts Hostile Takeover of Cephalon

It seems like hostile takeover bids in the life sciences industry may be de rigueur (how can anyone forget the Sanofi-Aventis/Genzyme hostile takeover saga that dragged on for almost a year). Interestingly, there have been 219 acquisitions of U.S. pharmaceutical companies in the past 12 months, with an average disclosed price of $153.7 million and an average premium of 44 percent!

Late yesterday, Valeant Pharmaceuticals announced plans for a hostile takeover bid for Cephalon, a 24 year old Pennsylvania-based biopharmaceutical company with eight products on the US market and more than 100 products worldwide. The takeover bid became “hostile” after Cephalon’s management team rejected earlier proposals.

Cephalon’s main focus is on nervous system disorders, pain and cancers. It is one of the world’s top 10 and most profitable biopharmaceutical companies. The company had revenues of $2.81 billion last year from sales of its narcolepsy treatment Provigil ($1.2 billion) and its leukemia treatment Treanda ($393 million). Also, according to the Cephalon website, there are several oncology products (lung, melanoma and solid tumors) in its development pipeline. In 2010 Cephalon announced seven acquisitions many of which were intended to bolster its oncology expertise.

Valeant Pharmaceuticals International, long a struggling speciality pharma company, merged with Biovail Corporation late last year and re-emerged as a re-invented company with substantial financial resources at its disposal. Prior to the Biovail merger, Valeant had a long history of acquiring smaller companies to bolster its R&D capability and its flagging drug development pipeline. The new company specializes in neurology and dermatology and has a diverse product portfolio that consists of branded pharmaceuticals, branded generics and over-the-counter medicines. In 2009, its revenues were $1.65 billion and 2010 revenues (to be released) are likely to exceed $2.0 billion. 

According to Bloomberg News, Valeant has offered to buy Cephalon for $5.7 billion in cash. Under terms of the offer, Valeant would pay $73 a share in cash; a 24 percent premium on Cephalon’s Tuesday closing stock price or a 29 percent premium to company’s 30 day trading average. Not surprisingly Cephalon executives summarily rejected the offer as “too low.” Several financial analysts concur with Cephalon and contend that the $73 per share cash offer undervalues the company’s true worth. Valeant and Cephalon are main competitors in the oncology and neurology markets.

Unlike the Sanofi/Genzyme bid, where it was clear at the outset to most observers that Sanofi would ultimately prevail, it isn’t clear whether or not Valeant will be successful in its attempt for Cephalon. While Cephalon has had its share of trouble with FDA over the past few years (for a variety of infractions including off-label marketing of Provigil), the company is in much better shape than Genzyme and the current management team has more resources at its disposable to ward off Valeant’s hostile takeover bid.

The downside of a Valeant-Cephalon merger would be job loss for many current Cephalon employees. This is because Valeant’s bid for Cephalon appears to be a “pipeline grab” rather than an R&D play. Typically, these types of acquisitions result in reorganization and downsizing of personnel because of duplication of effort. Only time will tell if Valeant will prevail.

Stay tuned for more late breaking news!

Until next time...

Good Luck and Good Job Hunting!!!

 

Insider Stock Trading....At FDA....Oh My!

The NY Times today reported that a 15-year veteran chemist at the US Food and Drug Administration (FDA) has been charged with using confidential and proprietary information about pending drug applications to buy and sell pharmaceutical and biotechnology company stock.

According to a criminal complaint filed by the US Justice Department, Cheng Yi Liang, 57 and his son Andrew made millions trading stocks on inside information since 2007. The criminal lawsuit alleges that the Liangs traded stocks in five pharmaceutical and biotechnology companies that had drug applications under review at the agency. Cheng Yi Liang’s job gave him access to a password protected-database that tracked the progress of new drug applications. Some of the companies leveraged by the Liangs included Vanda Pharmaceuticals, Clinical Data, Momenta Pharmaceuticals, Middlebrook Pharmaceuticals and Progenics. The Securities and Exchange Commission (SEC) simultaneously filed a civil securities fraud lawsuit against Cheng Yi Liang. 

The elder Liang is accused in the criminal complaint of “of using the FDA database to get an early look at F.D.A. decisions on companies developing drugs and then working with his son to trade on that knowledge, buying stock ahead of good news and selling it before bad news was announced. Both complaints assert that the defendants made just under $2.3 million in direct profits and avoided an additional $1.3 million in losses”. Further, the S.E.C. complaint accused FDA employee Liang of illegally trading ahead of more than two dozen F.D.A. announcements involving drug applications by 19 companies.

The case is noteworthy because, according to the Times article “it is uncommon for insider-trading investigations to involve FDA, despite the significant amount of market-moving information that passes through the agency each year. The agency maintains a rigorous ethics code and imposes significant restrictions on stock ownership and trading by its employees.”  The good news is that insider trading at FDA is rare and that a majority of its employee maintain ethical and moral standards that are consistent with the mission of the agency which is to supply the American public with safe and efficacious medicines. However, while the Liangs got caught, it does not mean that other less-than- scrupulous employees at FDA have also not benefited from less sophisticated insider trading schemes than those employed by the defendants. After all, FDA employees are human like the rest of us and the temptation to “get rich quickly” can be overwhelming especially during hard financial times.

Until next time...

Good Luck and Good Job Hunting (try FDA, there is at least one open position that needs to be filled)

 

Sales of Medical Marijuana Reported to Rival Those of Viagra: Who Knew?

Can getting high be more important than sex? Probably not if you are in your teens or early 20s, but if you are of  an age where managing the nausea associated with cancer chemotherapy or the pain of glaucoma then medical marijuana is likely to be more important than the need for sex! But, to be fair, despite the title of this post, Viagra will lose patent protection shortly (in some places it already has) and the drugs sales have been shrinking. Nevertheless, a report authored by See Change LLC, a Colorado company that provides investment advice to businesses found that the sale of  that medical marijuana has already reached $1.7 billion (in states where it is legal) as compared with annual Viagra sales of $1.9 billion!  

Unfortunately, See Change LLC is charging $1,150 for the report. And since I don't have the money to purchase  it, I cannot determine the veracity or accuracy of the report. But, according to comments made by the editor of the report roughly 1 in 4 Americans lives in a state in which medical marijuana is legal, and that nearly 25 million people in those states have medical problems for which the drug can be prescribed. The report suggests that medical marijuana sales will reach $8.9 billion in five years.

Despite repeated scientific findings that medical marijuana can be used to effectively treat a variety of clinical indications that include chronic pain, nausea and anxiety, the myth of marijuana as a gateway drug to more serious drug like cocaine, heroin and others has been indelibly burned into the American psyche—not withstanding the statistics that show that prescription drugs like OcyContin, fentanyl and methamphetamine are the most abused drugs in America.  

While marijuana hasn’t been a part of my life for over 35 years, there is no question that it has enormous therapeutic value and ought to be legally prescribed when appropriate. In my opinion, the only thing that is preventing marijuana from being legalized is a business model that allows corporate America and the US government to maximize profits  from sale of the "deadly weed." 

 

 

It is time for Americans to forever expunge the "unbridled horrors" of Refer Madness from their collective psyches!

Until next time...

Good Luck and Good Job Hunting (be careful out there)

 

FDA Inspections: Insights into Responding to FDA Inspectional Observations

US Food and Drug Administration (FDA) inspections of drug and devices manufacturing facilities are typically anxiety ridden exercises that can strike fear into even the most seasoned quality and regulatory affairs professionals. And, most manufacturing facilities do not escape these inspections unscathed and are routinely cited, in many cases, for minor infractions.

For those of you who may not be familiar with FDA inspections, manufacturing facilities that produce approved drugs and devices must be inspected every two years for insure regulatory compliance with Current Good Manufacturing Practices (CGMPs). During the inspection, FDA inspectors document “significant objectionable conditions, relating to products and/or processes or other violations of the Food Drug and Cosmetic Act” that they observe. These are known in the industry as Form FDA 483 Inspectional Observations or simply 483. Companies that receive 483s must correct the so-called objections conditions to remain CGMP compliant.

While receiving 483s during an inspection may be routine, it can be overwhelming to inexperienced companies and their representatives. With this in mind, I found a great blog post by Bruce McDuffee, Global Marketing Manager, Veriteq that provides insights on interacting with the agency to manage 483s. He offers the following advice:

“One thing that you should be clear about is that this is not a ‘warning letter’; it is an offer to help you resolve issues and improve your quality system. The FDA may or may not issue a warning letter next if you have not addressed the conditions of the 483 to its satisfaction. Receiving a 483 does not necessarily mean you are out of compliance.

In responding to a 483, your objectives should include these three things; establish credibility, demonstrate acknowledgement and understanding of the observations and the associated requirements and show commitment to corrective actions."

Bruce recommends that you take the following actions when dealing with 483s:

  1. Get your response in on time or even early if possible. The FDA wants to see the response within 15 days, so plan your review and internal processes accordingly.
  2. In the first paragraph, demonstrate your understanding of and desire to comply with FDA regulations.
  3. Respond individually to each item addressed on the form. Give a corrective action and time-frame for implementing.
  4. Prioritize by first addressing the conditions that will most likely affect product quality.
  5. Outline how and when each deficiency will be corrected.
  6. Avoid talking about whose fault the issue is or how it came to be. For example, keep a positive tone and indicate how the quality system will be improved.
  7. Include any reference documents, such as purchase agreements for a new monitoring system or employment agreement for a new quality manager.
  8. Keep in mind that there is a formal process available for you to dispute the findings.
  9. Be proactive in addressing the conditions. For example, address why the deficiencies were not detected internally and what will be done to correct this condition.
  10. Seek clarification with the inspector when you receive the 483 on the spot. Be sure you understand each objectionable condition before the inspector leaves the site. It may behoove you and your firm to seek out an industry expert if the matters seem complex or if the issues are not able to be resolved by your own personnel.”

While CGMP and regulatory compliance may seem like arcane concepts, they are vitally important and must be clearly understood by companies that are manufacturing FDA-approved drugs and devices. Failure to comply can result in penalties, monetary fines and revocation of a license to manufacture a drug or device.

Until next time....

Good Luck and Good Job Hunting (try regulatory affairs or quality assurance and control)

 

The Importance of Packaging and Labeling for CGMP Regulatory Compliance

As many BioJobBlogger readers know, the life sciences industry is highly regulated. And, companies that market and sell drugs must be compliant with the Current Good Manufacturing Practices (CGMPs) mandated by the US Food and Drug Administration (FDA) and other regulatory agencies.

While frequently overlooked, packaging and labeling of approved drugs plays a major role in the quality assurance standards that the FDA demands from licensed drug and devices manufacturers. The CGMPs mandate adherence to a variety of internal and external standards for packaging and labeling drugs. These include managing component materials suppliers and product sampling as well as in-process management of production personnel and the manufacturing process. FDA and other regulatory agencies frequently make changes to update and refine the guidelines for packaging and labeling requirements. Therefore, it is important for quality and manufacturing personnel to remain abreast of the most recent guidance documents issued by the agency.

To that end, the Global Strategic Management Institute (GSMI) is offering a course entitled “Packaging and Labeling for Quality Management Systems” which will be held April 27-28, 2011 in San Diego, CA.

Those who attend this two-day course will:

  • Learn best practices for implementing changes in packaging and labeling operations
  • Interact with instructor and attendees to assure system and regulation under standing
  • De­fine the components of a packaging and labeling system-based inspection
  • Establish maintenance standards for documentation and reporting
  • Determine validation standards
  • Mitigate risk by addressing compliance before inspections
  • Communicate, train and set quali­fications for personnel
  • Assess development and manufacturing practices that will be targeted
  • Provide controls to assure no negative impact on your products quality
  • Understand current legislation and trends set by FDA regulations

For more details, please download the brochure for the event by clicking here.

Persons who register by 28 March, 2011 will receive a $300 early bird discount from the registration fee. Also GSMI offer group rates for attendees. BioJobBlog readers who register and use the promo code “cliffm” will receive an additional 10% discount.

See you in San Diego!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!!

 

The "Thing" About Scientists

Let’s face it; most scientists are lousy communicators. While this is not an inherited defect, the poor communication skills exhibited by most scientists are a direct result of a lack of emphasis placed on oral and written communication skills during their training. In fact, being a “good communicator” may actually hinder a scientist’s success as a world class researcher. After all, prematurely divulging information or breakthroughs may result in being “scooped by the competition” both in terms of winning grant monies and publishing first. Consequently, from a Darwinian standpoint, good communications skills are a trait that may actually be selected against because they more than likely will reduce the overall competitiveness and “fitness” of most research scientists.

Deborah Blum a Pulitzer-Prize winning science writer and journalist at the University of Wisconsin-Madison and author of the blog Speakeasy Science nicely summed up the consequences of poor communication skills among scientists in a blog post entitled “The Trouble with Scientists:”

“Real” scientists share their work only with each other and do not attempt to become “popularizers” because that would lead to “dumbing down” the research.

She further asserts that this attitude has seriously compromised the lay public’s understanding of science.

"Scientists won’t talk to journalists; they don’t want to waste their time “dumbing it down”; they don’t see it as “making us smarter.” So, many of the good stories in science don’t get covered at all. Or the stories get covered only for an already science-literate audience – explored in publications like Discover or Science News – rather than for that far larger group, the science disenfranchised."

And, while many politicians and scientists loudly complain about the lack of science awareness and literacy in America Blum astutely asserts:

“Science writers, journalists, broadcasters and bloggers became the voice of science during a time during which too many scientists simply refused to engage. Scientists have ceded that position of power amazingly readily; ask yourselves how many research associations offer awards to journalists for communicating about science but none to their own members for doing the same. Ask yourself how the culture of science responds even today to researchers who become popular authors or bloggers, public figures. Whether young scientists are rewarding for spending time on public communication? And ask yourself how hypocritical this is, to complain that the general public doesn’t understand science while refusing to participate in changing that problem?”

Not withstanding the negative impact that poor communication skills have on the public’s understanding of science, good oral and written communication skills are now critically important for those scientists seeking jobs outside of academia. Poor communication skills are no longer tolerated outside of the ivory tower! A quick perusal of ads for non-academic science jobs reveals that “outstanding oral and written communication skills” are second only to technical skills for prospective new hires. Finally, the meteoric rise of social media suggests that communication—whether virtual or real —is critically important to most human beings (Facebook and Twitter as selective pressures?—go figure!). For those scientists who disagree with me, think about what I just said the next time that you are perusing your Facebook page, LinkedIn profile or getting ready to send your next tweet!

Unfortunately, I was trained by a generation of scientists who—as Blum put it—“hate-to-share!” Somehow, I managed to overcome it. Nevertheless, despite changing attitudes about the importance of good communication skills, the hate-to-share attitude is still pervasive in most graduate and postdoctoral training programs today. Sadly, this attitude is no longer sustainable in a world of diminishing grant monies, lousy job markets and increasing global competition. Unless this attitude changes, fewer and fewer scientists will be successful in their chosen field of endeavor!

Hat tip to Deborah Blum @ for the insights and words!

Until next time....

Good Luck and Good Communicating

 

A New Role for Academic Scientists in New Drug Discovery and Development?

There has been some buzz on LinkedIn and Facebook about an article that appeared in the March 3, 2011 issue of Nature Magazine. The article entitled “Traditional Drug-Discovery Model Ripe for Reform” and basically chronicles the decline in emphasis being placed by most companies on traditional in-house drug discovery as a source for new candidate molecules. Also, it points out that most big pharma companies now agree that they are not good at drug discovery but excel in clinical development and marketing of new medicines. Industry’s new view of itself is supported by the fact that over 200,000 pharmaceutical and biotechnology workers—roughly 50% were discovery scientists—have their lost jobs in the past three years or so. This begs the question “who is going to discover the new molecular entities that large drug companies are going clinically evaluate and ultimately market? According to the article, academic researchers are likely to play a pivotal role in this newly emerging drug discovery paradigm. 

The new model proposed in the article goes something like this. First, all intellectual property rights for certain compounds will be lifted or removed. Compounds of interest would subsequently be evaluated in small clinical trials for safety and possible efficacy. And, interested drug makers would only compete with one another on specific molecules after they were deemed safe and potentially effective. Up until this point, all data on prospective drug candidates would be openly published and freely available to interested parties.

Proponents of the model contend that the approach would allow drug targets to be more quickly validated and developed less expensively because there would less duplication of research activities. Further, it would reduce the exposure of patients to experimental molecules that have already deemed to be ineffective. Interestingly, the new model would rely exclusively on academic scientists who would be supported by a global initiative that cost about $325 million per years— with half coming from the pharmaceutical industry and half from the public. Finally, drug candidates identified in the initial screening process would be available to companies that participate in the initiative (presumably to the company that invested the most?)

While the proposed model is clearly “wishful thinking” on behalf of academics who are struggling to win grant support, it is deeply flaw and was obviously proposed by academic scientists who lack a clear understanding of the industrial drug development process. First, intellectual property (IP) and patents are the life blood of the industry and are in fact what allows drug companies to prevent competition in certain therapeutic areas maximize their return on investment on the drugs that they develop. Therefore, it is highly  unlikely that any drug maker would agree to lift or suspend IP around a novel new molecule. Second, must academic scientists are not qualified nor trained to engage in industrial drug development. Unlike academic science, industrial research is highly regulated and must be performed according the regulations and guidelines established by various regulatory agencies like the US Food and Drug Administration. If the research is not conducted in a regulatory compliant manner, then the prospective new drug will not be able to win regulatory approval. Third, eliminating IP would prevent university tech transfer offices—which exist almost entirely to manage a university’s IP—from negotiating lucrative licensing deals with interested companies or other parties. This, in turn, would reduce the contribution of funds by technology transfer offices that is used to run many academic research centers. Finally, the model is based upon the assumption that academic scientists (unlike drug companies) willfully and freely share information with one another for the “common good.” However, based on my experiences as an academic for over 20 years, most scientists don’t subscribe to the level of altruism and philanthropy attributed to them in the article. In fact the ego-involvement and competition amongst academics is so fierce, that  many academic refuse to share important new information or breakthroughs with their colleagues until grants are funded or the data are published in peer reviewed journals. Put simply, most academics are trained to work by themselves in their own laboratories and are neither interactive nor collaborative by nature.

There is no question that the old industrial drug discovery model is in transition and a new one will ultimately emerge. However, the role of academics in the new model is likely going to be less than proposed in present article. Too many systemic changes would be required for this model to be effective. That said, providing graduate students and postdocs with training in regulatory affairs and new drug development could be a step in the right direction! Nevertheless, a better solution to the problem may be a greater role for government in new drug discovery and development. To that end, the UK Medical Research Council has established the Developmental Pathway Funding Scheme that supports the development of promising basic science research into new drugs and medical devices. Also, Francis Collins, the current head of the National Institutes of Health has proposed the creation of a National Center for Advancing Translational Sciences to transform basic science into prospective new drugs and treatments.

Despite the good intentions of the article, the path forward for academic scientists is not going to be easy. To make matters worse, it is becoming increasingly difficult for PhD-trained scientists to find jobs. That said, if you are truly interested in industrial drug discovery and development I highly recommend that you take some regulatory affairs course or enroll in a certificate or MS degree program in biotechnology that teaches the business side of the life sciences industry.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!!

 

A Possible Bump in the Road for the Sanofi-Genzyme Deal: Patients Sue Genzyme Over Fabrazyme Shortages

The almost two-year manufacturing woes of orphan drug manufacturer Genzyme have been well documented and publicized. Despite these problems and an FDA consent decreed, it was not enough to stop Sanofi-Aventis from doggedly pursuing Genzyme as a take over target for the past year.

As you may recall, production shortages of several of Genyzme’s key products, most notably Fabrazyme, a treatment for Fabry disease (a rare genetically inherited lysosomal enzyme storage disease) forced Genzyme to ration Fabrazyme to patients. Fabrazyme is the only approved treatment for Fabry disease and the rationing plan called for patients already taking Fabrazyme to receive half the approved dosage while newly diagnosed patients were prevented from receiving the drug at all!

A post on the Pharmalot blog last week revealed that at least half a dozen patients with Fabry disease who were taking Fabrazyme filed a lawsuit against Genzyme and New York’s Mt. Sinai Medical School for the ongoing shortages and the ill-conceived rationing plan. According to the lawsuit, as many as three patients with Fabry disease have died as a result of the Genzyme rationing plan. Mt. Sinai was named as a co-defendant in the case because it licensed Fabrazyme to Genzyme and went along with the company’s rationing program. Further, the lawsuit contends that neither Genzyme nor Mt. Sinai had adequately tested whether or not the reduced dosage was effective as a treatment for Fabry disease. Obviously, the FDA approved Fabrazyme as a treatment for Fabry disease based on the dosage information that Genzyme determined to be optimal in it BLA.

The lawsuit will likely never make it to trial (Genzyme will undoubtedly settle) and therefore have little or no impact on the impending acquisition of Genzyme by Sanofi-Aventis. Companies that are being acquired or merging don’t like it much when there is outstanding litigation that may interfere with the transaction.

Nevertheless, Genzyme’s manufacturing problems highlights one of the weaknesses of the US Orphan Drug Act. For those of you who may not know companies granted approval of drugs for orphan indications (< 200,000 patients) are guaranteed seven years of market exclusively (along with tax credits, grants and less onerous clinical trials). This means that no other company (aside from the innovator company) will be granted regulatory approval for a similar orphan product for seven years from the approval date of the first product. Not surprisingly, this forces patients with orphan diseases to exclusively rely on a single drug that is manufactured by a single company i.e. there is no backup. And, if an orphan drug manufacturer has regulatory compliance issues or goes out of business etc the patients that rely on the drug are SOL (as it is said in the vernacular). Unfortunately, this was exactly what happen with Fabrazyme when Genzyme’s chronic manufacturing problems resulted in shortages of the drug.

While many people take drug companies to task for developing so-called “me too” drugs there is a reason why FDA and other regulatory agencies approve them. That is: when there is more than one manufacturer of drugs that treat a particular indication then there will be alternate treatments available to patients if something goes awry with one or another of the products. Although I am a strong proponent of the Orphan Drug Act, the recent entry of several major pharmaceutical companies like Pfizer, GlaxoSmithKline and others into the orphan drug development space suggests that the seven years of market exclusivity offered by the Act may no longer be necessary. Further, shortening or eliminated the market exclusivity term would like help to increase competition among orphan drug developers. Increased competition would, in turn, and then help to drive down the price of orphan drugs which are currently exorbitantly expensive and sometimes not covered by insurers. Changing the orphan drug act would primarily benefit patients with rare diseases and not drug makers. And, in the end, helping patients is admittedly all that matters!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

 

It Had To Happen Sooner Or Later: FDA Slaps J&J With A Consent Decree For Permanent Injunction

The US Food and Drug Administration yesterday announced that a consent decree of permanent injunction has been filed against McNeil-PPC, the consumer products division of Johnson and Johnson, and two of its senior executives, for “failing to comply with current good manufacturing practice requirements as required by federal law. The action prevents McNeil, a subsidiary of Johnson & Johnson, from manufacturing and distributing drugs from its Fort Washington, Pa., facility until the FDA determines that its operations are compliant with the law.”

McNeil Consumer Healthcare Division’s Vice President of Quality Veronica Cruz and the company’s Vice President of Operations for OTC Products Hakan Erdemir were named defendants in the consent decree, filed with the U.S. District Court for the Eastern District of Pennsylvania in Philadelphia on March 10, 2011. The highest ranking company executives in charge of the facilities named in a consent decree are always included (by law) on the civil action.

The decree also requires McNeil to adhere to a strict timetable to bring its facilities in Las Piedras, Puerto Rico, and Lancaster, Pa., into compliance.

Consent decrees are civil actions—not criminal ones— and are meant to be remedial rather than punitive. In other words, there are no fines levied and the agency expects the companies under consent decree to bring their manufacturing facilities back in to compliance with Current Good Manufacturing Practices (CGMP). However, if the company fails or refuses to comply with the FDA, criminal charges can be filed against the companies and the two executives mentioned in the consent decree. The agency had little choice but to seek a consent decree of permanent injunction against McNeil because of manufacturing problems and recalls of several of its signature brands including Tylenol, Motrin, Zyrtec, and Benedryl. Criminal charges may be forthcoming because of possible cover ups of the recall that involved hiring outside contractors to purchase tainted produced in bulk to surreptitiously remove them from store shelves.

FDA had little choice but to seek a consent decree because of the seriousness and continuous nature of the problems at its Fort Washington production facility and the fact that J&J senior executives were either unaware or unconcerned with the problems at its subsidiaries. While working under a consent decree may be embarrassing for J&J, the damage caused by the recalls of some of its most visible consumer and OTC brands may be irreparable.

 Until next time...

Good Luck and Good Job Hunting!!!!!!!!!!

 

The Dark Side of Personalized Medicine And Sports Genetic Testing

Like it or not, the possibility of money and profit drives science just like it does any other field. Therefore, it should come as no surprise that a few genetic testing companies have created DNA-based kits that purport to be able to predict the athletic capabilities of children and young adults. 

The kits developed by Australia-based Genetic Technologies (sold in the US by Atlas Sports Genetics) and CyGene Laboratories of Coral Springs, FL are based on variations or single nucleotide polymorphisms (SNPs) of the alpha actin-3 (ACTN3) gene that encodes a protein involved in actin development of muscle fibers in skeletal muscles. Atlas sells the kit for $169 whereas CyGene’s kit costs $100. 

Presumably, kids that possess the appropriate ACTN3 DNA sequences may be athletically more gifted than those who do not. As we scientists know, innate athletic ability is more than likely a multigenic trait and the presence or lack of a single DNA sequence or SNP cannot reliably predict a person’s future athletic potential. However, most parents who already have been sold on the power of personalized medicine do not! Again, it should come as no surprise that parents are buying these kits and testing their children to determine whether or not they ought to sign their kids up for pee wee soccer or T-ball at age 3! Perhaps, even more egregiously, is what may happen to the kids who test “negative” for ACTN? Will they be relegated to the bench (pardon the pun) for the rest of their lives? To wit, researchers at the University of Wisconsin-Madison (my alma mater) this week published a commentary in the Journal of the American Medical Association to disabuse parents that these tests are predictive of their children’s athletic ability or even worth the money they paid to purchase them!

Like these authors, I believe that the companies that developed the ACTN3 tests are clearly putting profits before science. There is no question that we have entered the “age of personalized medicine.” But, most personalized medicine tests are still not ready for prime time and companies that assert that it is are being deceptive or disingenuous at best. Similar sentiments were echoed by J. Craig Venter in an interview that I conducted with him which is published in this month’s edition of Life Science Leader. Like him or not , without Venter, the so-called age of personalize medicine would have likely been delayed by three to five years or more. Nevertheless, put simply, at its current stage of development, personalized medicine is clearly being oversold to the American public!

There is no question that real personalized medicine will be a reality in the next 5 to 10 years. hat said, we are simply not there yet. The fact that many genetic tests like ACTN3 are not regulated by the US Food and Drug Administration suggests that new regulations and over sight for them is desperately needed! Also, new initiatives must be created to improve the US public’s understanding of science—it can no longer be ignored as we continue our push into the age of personalized medicine!

Until next time...

Good Luck and Go Badgers!

 

Why Is Video Not Catching On in the Life Sciences Industry?

While video may be losing some of its “newness" and cache in social media circles, it continues to grow and has become a mainstay of networking platforms like Facebook, Twitter, and of course YouTube!  Despite its popularity in most industries, the life sciences industry continues to eschew its use. The reasons for this are not clear but it is counter intuitive given the billions of dollars the pharmaceutical and biotechnology companies annually invest in direct-to-consumer advertising

Several big pharma companies, most notably Johnson & Johnson, have attempted to increase the use of video to connect with its stakeholders but its efforts haven’t yield much of an ROI. I suspect that most industry insiders will tell you that the main reason why video is not routinely used is the lack of regulatory guidelines guiding its use on social media platforms. While this is a facile explanation, the existing regulatory guidelines for direct-to-consumer television advertising certainly apply to video!

In a post today on the EyeonFDA blog, Mark Senak offers a variety of ways in which life sciences companies can leverage video to their advantage to promote good will among shareholders and stakeholders alike. His ideas make sense and are very much within the regulatory guidelines for direct-to-consumer advertising. Whether or not direct-to-consumer advertising is a good thing is a topic for another post!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!

 

What's Up With FDA Inspections Anyway?

BioJobBlog readers who understand Current Good Manufacturing Practices (CGMP) for pharmaceuticals and biologics know that the US Food and Drug administration is mandated to review approved drug manufacturing facilities once every two years. While this is the mandated inspection schedule, most industry insiders know that manufacturing plant inspections now take place once every three or more years. This has resulted because of an increased reliance by US drug makers on foreign manufacturing facilities to produce licensed pharmaceuticals and biologics, a lack of regulatory oversight by the agency during the Bush administrations and funding shortfalls that have resulted in a shortage of FDA inspectors.

Congress recently took the agency to task about a lack of oversight for food and drugs manufactured in foreign countries. In September, the Government Accountability offices reported that FDA inspects foreign drug facilities on average once every nine years as compared with every 30 months or more with US plants. To correct this, FDA announced that it aims to increase reliance on third party inspectors in other countries to maintain better oversight of ex-US manufacturing plants. In other words, it is less costly to train and work with inspectors already in foreign countries rather than send US inspectors overseas.

In a post last week on the Pharmalot Blog, Ed Silverman reported that Bloomberg News reviews almost 10,000 inspections at US manufacturing plants from 2000 until September 30, 2010. While the Bloomberg report did not provide details on the frequency and nature of violations uncovered at the inspections, the results of the reports were eye-opening. According to Ed:

“The FDA makes 0.9 visits, on average, to each facility each year, compared with 0.6 visits annually when George W. Bush was in the White House. Looked at another way, the agency NOW visits each of the 2,567 plants registered in the US almost once a year.”

Further he noted:

“Some of the biggest drugmakers do not have a good track record when it comes time for FDA inspectors to visit their plants. Overall, the FDA found violations at 54 percent of plants inspected last year, up 20 percent from a decade low in 2007, according to data obtained from the agency by Bloomberg News. And 80 drugmakers failed more than half of their inspections.”

So, which companies had the poorest inspection track records? Ed noted

“Abbott Labs failed 59 percent of 111 inspections; Pfizer flunked 57 percent of 202 inspections; Merck bombed out on 52 percent of 134 visits and Johnson & Johnson failed 48 percent of 161 inspections. By contrast, [generic drug manufacturer] Mylan passed 79 percent of 56 inspections!”

Republicans are threatening to slash FDA funding for US inspections mainly because the agency is focusing more on overseas manufacturers and suppliers. In response to the funding cut threats, the Obama Administration proposed that drug manufacturers whose production plants fail inspections would be required to pay fines of roughly $49,000. At present, there are no mandatory fines levied against drug makers that fail FDA inspection (the agency can and does impose fines if companies that fail inspections refuse or are reluctant to fix the problems that were uncovered).

I find it interesting that despite the numerous drug recalls and problems with drug safety of approved drugs over the past few years that the Republicans, could in good conscience, threaten to cut FDA funding to increase the frequency of inspections to bring them in line with the mandated once every two years rather than once every 2.5 to 3.0 years that has been the norm for the last decade.

Until next time....

Good Luck and Good Job Hunting!!!!!

 

Two New, "Must-Read" Books on Vaccines

I was listening to Radio Times today on National Public Radio which featured Paul Offit, MD and Seth Mnookin as guests. Both have written new books on the devastating consequences that the American anti-vaccine movement has had on US public health.

Paul Offit, a pediatrician, vaccinologist and outspoken critic of the anti-vaccine movement has written a new treatise on the topic entitled Deadly Choices: How the Anti-Vaccine Movement Threatens Us All. Likewise, Seth Mnookin, a writer and contributing editor to the magazine Vanity Fair has written a book entitled The Panic Virus: A True Story of Medicine, Science, and Fear. 

Both try to dispel the misinformation about childhood vaccines, the erroneous link between autism and these vaccines and the psychology behind the conspiracy theories and fear of modern vaccines. I highly recommend that parents read these new books before making the wrong decision to not to vaccinate their children. By not vaccinating their children, these parents put them at risk for contracting potential lethal childhood viral and bacterial infections. 

Until next time...

Good Luck and Good Job Hunting 

A Good Example of Why Politics and Science MUST NEVER Be Mixed

Last week, the US House of Representatives voted to cut FDA funding by $220 million. The House vote was not surprising given the prevailing attitude among many pharmaceutical and biotechnology company executives that FDA approval of new drugs and devices has become increasingly difficult. While there is no question that the current approval process for new drugs and devices has become more rigorous as compared with the incredibly lax process (and in some cases, the almost non-existent process) used during the Bush Administration, the FDA is simply fulfilling the mandate for the agency when it was created in 1938. That is: to provide the American public with SAFE and efficacious drugs to treat unmet medical need. 

Until recently, the FDA had been chronically under funded. And, because of this, the American public was forced to suffer through the Vioxx scandal, the heparin scare and the appearance on the market of many unapproved medical devices. These and other events that occurred over the past decade beg the question: “Should the American public’s safety be placed in jeopardy again simply because the Republican-controlled House is looking for ways to cut deficit spending?”

Unfortunately, the activity of anti-FDA lobbyists (funded mainly by US pharmaceutical and biotechnology companies) has been ramped up ever since the Democrats lost control of the House. And, since most Republicans believe that any government regulation whatsoever is too much regulation, it is easy to understand the House would vote to cut FDA funding. Nevertheless, insufficient funding will not allow the agency to hire the number of inspectors required to insure that drug manufacturing is conducted according to FDA-mandated regulatory guidelines. These activities are essential to insure the safety of the prescription drugs and medical devices sold on the US market.

According to FDA Current Good Manufacturing Practice (CGMP) guidelines, drug manufacturing plants for all approved drugs and devices are to be inspected every two years. Inspections are required for all manufacturing plants in the US as well as FDA-approved manufacturing facilities overseas. Because of ongoing shortages of FDA inspectors (and the emergence of numerous overseas manufacturing facilities), these inspections are typically conducted every three to five years rather than every two years! Clearly, this is not in the best safety interests of the American public.

A report published by the General Accounting Organization about the heparin scare of three years ago nicely sums up the issues.

“In its response to the heparin crisis, FDA took several actions related to its responsibility to protect the public health by ensuring the safety and security of the nation’s drug and medical device supplies. FDA increased its activities related to oversight of heparin firms by conducting inspections and investigations and monitoring heparin imports, and worked with drug and device manufacturers to recall contaminated products while ensuring that an adequate supply of uncontaminated heparin was available. With the help of external entities, FDA identified the unknown contaminant and developed tests to screen all heparin products. Additionally, the agency reached out to its international regulatory partners during the crisis. However, FDA faced some limitations in its efforts to inspect heparin firms in China and collaborate internationally, and the agency was unable to determine the original source of contamination.”

Interestingly, as today reported by the EyeonFDA blog, the U.S. House of Representatives Energy and Commerce Committee announced today that it was re-opening examination of the heparin contamination issue.  A letter was sent by the Chair of the Committee, Rep. Fred Upton (R-MI) as well as other members to FDA Commissioner Margaret Hamburg requesting that the agency supply all documents in connection with the heparin investigation from January 1, 2008 until present.  In its announcement, the Committee stated:

“It has been almost three years since the FDA linked deaths and serious allergic-type reactions of patients in the United States to supplies of heparin that came from the People’s Republic of China which was adulterated with overly sulfated chondroitin sulfate (OSCS). FDA officials believe this was an instance of economically motivated adulteration,” the members wrote. “However, neither the Chinese government nor the FDA has identified those responsible for the contamination or described how the heparin actually came to be contaminated.”

Mark Senak, author of  EyeonFDA blog aptly noted:

"It is certainly important in that any public health crisis involving the contamination of food or drugs be thoroughly investigated. But the investigating body can’t have it both ways. You can’t criticize an agency for not conducting inspections that are not funded by the same members of the same investigative body."

Is this any way to run a country?

Until next time...

Good Luck and Good Job Hunting!!!!!!!

 

It's Almost Official: Sanofi and Genzyme Reach An Agreement...In Principle!

Reuters reported today that Sanofi Aventis has reached an agreement in principle to purchase Genzyme for $19 billion in cash and future payments based on the performance of Lemtrada, Genzyme’s experimental treatment for multiple sclerosis.                     

The $19 billion dollar deal translates into $74 per share in cash plus a contingent value right for Lemada that Genzyme investors will receive. Interestingly, the $74 per share stock price is the original amount that Genzyme’s board asked for when the saga to purchase the company began last August. Go figure.....

The deal is the second biggest in biotech history (second to Roche’s acquisition of Genentech) two years ago. I don’t know about you but I am glad that the deal is almost done and we don’t have to hear about it anymore. That said, I hope that Sanofi gets what it paid for! And, if I were a Genzyme employee (especially Henry Termeer, Genzyme's embattled CEO) I would dust off the old resume or CV as quickly as possible. 

Until next time...

Good Luck and Good Job Hunting!!!!!

 

Rumor Has It That Sanofi Aventis May Be Looking to Make a Big Play in Ophthalmic Indications

According to a "mention" today on the Pharmalot blog, a French newspaper reportedly learned that Sanofi-Aventis may be spending up to $1 billion this year to acquire up to four ophthalmology companies. Although the companies were not identified, three of the companies that Sanofi is eying (pun intended) are located in the US and the fourth is reportedly in Israel.

An aging global population coupled with the diabetes epidemic plaguing the US and several other Western countries suggest that ophthalmology drugs may be a good bet for the future. This, coupled with the impending acquisition of Genzyme suggests that Sanofi-Aventis is trying to create somewhat of a soft landing for the company after patent expiry in early 2012 of Plavix, its major money maker.

Until next time...

Good Luck and Good Job Hunting!!!!!

 

A Sign of the Times: BioJobBlog Takes the Plunge!

Many of you may know that I started BioJobBlog four years ago. To date, I have posted close to 1300 articles and over 1.5 million people have visited the blog. While the fact that between 65,000-70,000 unique users visit the blog monthly is emotionally gratifying and rewarding, I have been self funding the venture since its inception and my operating expenses have sadly gone up!  This, coupled with my oldest son starting college next fall (and my other son two years from now), I have come to the conclusion that I can’t afford to spend as much time on the blog as I would like. Put simply, I need to focus on paying jobs (not BioJobBlog) that help to pay the mortgage and defray the cost of supporting my family.

To that end, today, I want to formally announce that BioJobBlog is now accepting paid advertising on the site! If you look at the side bar there are (3)-125 x 125 pixel ads and (1)-120 x 240 pixel ads that are available. These ads are part of the OpenX ad network and I hope that the modest revenue generated from the ads will allow me to continue to invest the time and energy necessary to create the content for BioJobBlog.

I haven’t established firm pricing yet but it will be competitive and the first person to advertise will get a guaranteed deal. Contact me for additional information and pricing.

To be clear, the advertising will not affect the content or the point of view on any future posts. Despite my socialist leanings, the bottom line is that putting a kid through college these days costs an exorbitant amount of money. That said, abolishing tenure makes a lot more sense now than it ever has in the past!

Until next time...

Good Luck and Good Advertising (@BioJobBlog)

 

Some Medical Devices Companies Jump on the FDA-Bashing Band Wagon

Many life sciences company executives will tell you that getting US Food and Drug Administration (FDA) approval for their products has gotten tougher than it has been in the past 10 years or so. This shouldn’t come as a surprise to most BioJobBlog readers because there was almost know regulation of pharmaceutical, biotechnology and medical devices products during the eight years that Bush was in power. Seemingly, many life sciences companies have forgotten that FDA’s mission is to provide the American public with SAFE and efficacious drugs and devices; not to quickly approve products to bolster a company’s stock share price. That said, some medical devices companies, like their pharmaceutical and biotechnology cousins, have begun to complain about the FDA regulatory process for medical devices.

Historically, the regulatory challenges for getting medical devices approved have always been much lower than those for garnering approval of prescription drugs, vaccines and other biological products. Since 2000, the regulations guiding regulatory approval for medical devices had grown extremely lax.  For example, there has recently been a spate of recalls for certain previously-approved devices including cardiovascular stents, implantable cardiac devices and hip replacements.

The Obama administration is attempting to restore the rigor of the approval process and some medical devices companies are extremely unhappy about it. This renewed effort has forced some devices companies to eschew the lucrative US devices market entirely in favor of European and Asian markets; mainly because they were unable to garner FDA approval for their devices. Interestingly, the companies that are complaining the loudest are start ups rather than established medical devices companies. Their main complaints are the ever-increasing size of the clinical trials and length of time it takes to win regulatory approval for their products. Not surprisingly, these complaints are mostly driven by financial pressures at the start ups. Because of the recession, many of the venture capitalists who backed these companies have less money to invest and demand quicker and higher returns on their investments. Consequently, many of the star tups are under capitalized and simply don’t have the financial resources to stay in business and wait for FDA approval. While I understand their business pressures and urgency, winning FDA approval is suppose to be about safety and efficacy not about ROI. Maybe start up devices companies experiencing these difficulties ought to retool or reinvent their business plans!

To be clear, FDA approval rates for medical devices are down; 19 premarket approvals (PMA) were granted in 2010 as compared with 48 in 2000. Also, the average time to win 510(k) clearance (less stringent than PMA and used for most devices) rose to 116 days in 2008 from 97 days in 2002. There is no question that winning regulatory approval for new medical devices may seem to be getting tougher than in the recent past. But, if that helps to improve efficacy and patient safety than I don’t necessarily think that it is such a bad thing. And as Stephen Oesterle, MD senior vice president for medicine and technology at Medtronic (one of the world’s largest medical devices companies) aptly said in a recent NY Times article “The FDA is asking for larger trials, more thoughtful trials, all in the interest of the American public.”

Until next time...

Good Luck and Good Job Hunting!!!!

 

DNA Portraits: Promoting Science Literacy?

There is no question that DNA, genome sequencing and personalized medicine are on their way to becoming part of the American lexicon. While most Americans haven’t a clue as to what these words mean, many have jumped on the “DNA bandwagon” because of television shows like CSI and its derivatives and high profile genetic information companies like 23 and Me, which was co-founded by Anne Wojcicki a Yale undergraduate biology major and wife of Google founder Sergey Brin.

Countless numbers of Americans have sent DNA samples to be analyzed by 23 and Me and other genetic information companies to learn about their ancestry and possible health implications contained in their genetic codes. Although the technologies used by these companies may not be ready for prime time-use for personalized medicine purposes, they are scientifically sound and relevant. Imagine my surprise when I read about a company called DNA11 that promises to create customized art from a person’s DNA. Yup, you heard me correctly—a customized DNA portrait! 

Here is how it works. Customers send a cheek swab (DNA sample) to the company and they sequence it. Then, a personalized DNA portrait is constructed from the code. Clients get to choose the color and size of the portrait and can also elect to have up to four person’s DNA added to it! And the best part is that it only costs $199 (starting price)! Of course, DNA samples are marked with anonymous codes and are supposedly destroyed after portraits are rendered.

DNA 11 is the brain child of Nazim Ahmed a former DNA imaging salesperson and Adrian Salamunovic a web designer. I have to admit that I thought the idea was a cool one! But, then again, I am a geeky scientist and the transformation of science into art is an intriguing proposition! Also, if positioned correctly, DNA11 could help to promote scientific literacy in the US.

The company has been featured in the New York Times, Wired Magazine and others on “The View” CNBC and the Discovery Channel. Moreover, both Nazim and Adrian have reportedly made millions and their products were recently featured on a recent CSI episode. Recently, the company announced that a portion of its revenue will be donated to charity. Nevertheless, I can’t imagine that, these days, most lay people have enough disposable income on hand to spend it on a less-than-useful DNA portrait. That said, I have been known to be wrong in the past. And, I have learned over the years that anything is possible in America--not that there is anything wrong with that!

Until next time...

Good Luck and Good Genetic Profiling!!!!!!!

 

Sanofi-Genzyme Deal Update: The End May Be Near

After seven months of public bickering over an appropriate sale price, the NY Time reports today that Sanofi Aventis may have hammered out a deal that would enable the French drug maker to acquire the world’s largest orphan drug manufacturer Genzyme for $19 billion. According to the report, Sanofi will acquire Genzyme for a $74 per share which is up from it previous offer of $69 per share.

Most analysts and the Genzyme management team felt that the previous $69 per share offer was too low and that the tipping price would be in the mid 70s. This made sense even to outsiders like me because Eli Lilly purchased ImClone, a company with only one approved product on the market, for $70 per share several years ago. Genzyme has multiple FDA-approved products with a strong late stage drug development pipeline. Not surprisingly, Sanofi tendered a low initial stock price purchase offer to give itself flexibility when it decided to enter into serious negotiations.

Despite the long drawn out and tiresome melodrama, the deal is a good one for Sanofi, a company that desperately needs to bolster its biotechnology pipeline and also for Genzyme which has been rocked by biomanufacturing and quality problems for the past couple of years.

Now that this deal is imminent, does anyone have an idea about which biotechnology company may be the next takeover target?

Until next time..

Good Luck and Good Job Hunting!!!!!!!!

 

At Long Last: Sanofi and Genzyme May Be Close to a Deal!

After a five month-long series of  very public and often acrimonious negotiations, it appears that Sanofi-Aventis and Genzyme may be close to deal that would enable the French drug maker to acquire one of the world’s largest public biotechnology companies.

According to the NY Times and a number of life sciences blogs, both companies have agreed in principle on a framework for a takeover deal. The major sticking point in the negotiations is Sanofi’s tender offer of $69 per share of Genzyme stock. Genzyme executives and industry analysts view the offer as “too low” and believe that a stock share price in the mid-70s is more reasonable and likely in the end. Another sticking point is the success of Genzyme’s leukemia treatment Campath (alemtuzumab, which is in clinical development to treat multiple sclerosis but will be marketed under the brand name Lemtrada if approved). Genzyme believes that Campath will likely be a winner whereas Sanofi executives are not so sure. Consequently, the deal will likely include additional payments to Genzyme if the drug meets or exceeds certain sale targets for either or both indications.

Persons with knowledge of the negotiations suggest that the specifics of a deal will likely be worked out of the next week or so. This is because, on Monday, Sanofi signed a nondisclosure agreement with Genzyme to conduct due diligence for the deal. Really? What has Sanofi been doing for the past 5 months?

The Genzyme deal is critical for Sanofi which desperately needs to quickly get into the biotechnology game, particularly in the areas of oncology and neurological disorders. Last week, Sanofi’s experimental drug to treat breast cancer, iniparib failed to meet clinical endpoints in a late stage clinical trial. Also, Plavix, Sanofi’s top-selling anti-clotting drug will lose patent protection in May 2012 (FDA recently gave Sanofi an additional six months of marketing exclusivity based on a newly awarded pediatric indication). Plavix is the world’s second best selling prescription medication.

I don’t know about you, but I hope that this deal gets done soon! From the outset, it was apparent to most life sciences pundits and industry insiders that Sanofi would prevail and ultimately acquire Genzyme. Unfortunately, Genzyme’s ongoing manufacturing woes provided Sanofi with an excuse to “lowball” its initial offers. And, surprisingly, Genzyme’s management team had the chutzpah and wherewithal to push back hard.  The bottom line: it is a great deal for both companies—“Just Do It.”

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

 

Social Media And Advertising

Facebook has over 500 million users and Twitter has close to 175 million who write 95 million tweets daily. Conventionally wisdom suggests that using either of the platforms to advertise or brand a product or service would be a no brainer. However, my experience with paid ads on Facebook (I haven’t tried Twitter yet) suggests that the ROI on using social media to advertise may not be that substantial. There is no question that using social media tools like Facebook, Twitter, GroupOn  to build brand awareness or create a buzz about a product or service or to share coupons is extremely useful. But for straight up advertising and click through rates—not so much!!!

I will be the first to admit that I know little about marketing and advertising (although I did take an advertising class as a microbiology major @Cornell). However, the sheer number of users on Facebook and LinkedIn, suggested that I may be able to grow membership @ BioCrowd and promote readership @ BioJobBlog by advertising on these platforms. To that end,  I invested several hundred dollars into advertising campaigns on both platforms. Unfortunately neither campaign had any noticeable effects on enrollment at BioCrowd or readership at BioJobBlog. I attributed the lack of success of these campaigns to my woeful understanding of the arcane disciplines of marketing and advertising —I am a scientist, after all! 

Imagine my surprise (and delight) when I read an article in a local newspaper entitled “More and More Executives Using Social Media to Promote Business” which described several business owner’s experiences with advertising on social media that were identical to mine! Like me, they thought that advertising on Facebook and other social media platforms was so obvious that they couldn’t pass on the opportunity. Also, like me, they were extremely disappointed with the results. For example, a Princeton, NJ-based clothes retailer (which caters to college students) invested $500 on a Facebook ad. While the ad, that offered 20 percent discounts on clothing, received 1 million page views, not a single one translated into a sale! Others described similar experiences. I guess the old saying “misery loves company” may be apt here.

Although some still consider social media to be a passing fan, I strongly disagree. I think that social media is clearly here to stay and has become an essential way in which we communicate with one another. That said, because social media is only about six years old, it may be too soon to determine whether or not advertising on Facebook, Twitter, LinkedIn or other social media platforms can translate into a reasonable ROI. I guess only time (and money) will tell!

Until next time...

Good Luck and Good Job Hunting!!!!

 

What Ever Happened to Amgen?

Five years ago Amgen was the world’s largest biotechnology and was, by many accounts, the darling of Wall Street. But, today, there is little mention of the once formidable biotechnology company that many startups attempted to emulate. Like other companies, Amgen ran into pipeline problems, medical issues with existing blockbuster drugs (remember the whole hematocrit brouhaha over Epogen and Aranesp its flagship anemia products), lower drug sales and ultimately the perception that the company had lost its innovative edge. However, it now appears that Amgen is making something of a comeback and may have been quietly preparing itself for its  “rebirth” over the past few years.

According to an article in today’s NY Times, Amgen agreed to purchase BioVex, a closely held oncology company for $425 million and as much as $575 million in milestone payments. BioVex’s lead product, an experimental cancer vaccine Oncovex, is in late stage clinical development. It was developed to treat metastatic melanoma. Oncovex is also being evaluated for head and neck cancer.  Over the past five years, Amgen has acquired seven companies (with an average deal value of about $264 million) in oncology and other therapeutic areas indicating a willingness to create new drugs to treat diseases rather than symptoms commonly associated with them.

In other news, the company announced that it was raising it price for some of its largest selling drugs including Aranesp, Neupogen and Neulasta. Another sign that the once mighty company may be trying to get back into the game and compete with archrival Genentech (now a subsidiary of Roche) for the title of the world’s largest biotechnology company.

Until next time...

Good Luck and Good Job Hunting!!!!!!.

 

BioCrowd and Quertle, a New Biomedical Literature Search Engine, Ink a Deal

BioCrowd (www.biocrowd.com) and Quertle (www.quertle.info) announced today that BioCrowd has enhanced its site by embedding Quertle's semantic biomedical search engine. BioCrowd is an online networking site for bioprofessionals that offers it members discussions, blogs, podcasts, job searching tools, and research product reviews. With the addition of literature searching capability via Quertle's new generation biomedical search engine, BioCrowd has evolved into a one-stop site for persons involved in biomedical research.

Quertle's search engine uses advanced linguistic methods to find conceptual relationships, not just query terms scattered throughout a document. Searches yield highly relevant documents instead of the long lists of sometimes incomprehensible results offered by other literature search sites. Quertle's pioneering approaches, including Power Terms™ - which represent entire classes of related concepts such as "diseases" - provide its users with a means to quickly get answers and make discoveries through literature searches.

By accessing Quertle through BioCrowd, community members will now have full access to a gamut of web resources routinely used by life scientists. "Embedding Quertle in BioCrowd adds the best literature searching capability to an existing tool chest of key web resources," said Professor Vincent Racaniello, a virologist at Columbia University School of Medicine and a BioCrowd co-founder. "There is no longer a need to visit multiple sites to gain access to the tools and functionality demanded by life sciences researchers." Clifford Mintz, PhD, BioCrowd's Chief Business Officer added, "We talked to a variety of biomedical search engine companies and Quertle's product surpassed its competitors."

About BioCrowd

BioCrowd is an online networking site exclusively designed for bioscience professionals. It was started by Clifford S. Mintz and Vincent Racaniello, two longtime bioscientists, who recognized a need for junior and senior scientists to network with one another and other bioscience professionals to realize and achieve professional or career goals.

About Quertle

Quertle is a biomedical search engine focused on delivering informative results to biomedical researchers using advanced linguistic technologies and an in-depth understanding of the biomedical field.

 

Sanofi Inching Closer to Purchasing Genzyme

The buzz at the JP Morgan Healthcare Conference that is taking place in San Francisco this week is that Sanofi-Aventis and Genzyme are close to inking a deal. As you may recall, Sanofi made an unsolicited offer last summer to buy the troubled orphan drug manufacturer. Sanofi offered to purchase Genzyme for $69 per share but the offer was summarily rejected as “too low” by Henri Termeer, Genzyme’s embattled CEO who has been running the company for over 20 years since its inception.

The very public and often acrimonious haggling over the purchase price has become legion in some investment banking and bioventure circles. Nevertheless, most industry and financial analysts predict that Sanofi will prevail and ultimately acquire Genzyme possibly for a share price in the low to mid $70s.  Sanofi desperately needs Genzyme to get into the biotechnology fracas; a field that it seemingly chose to largely ignore for the past 20 years--go figure!  Consequently, it is likely that Sanofi will eventually give Genzyme everything it wants to consummate the deal

Yet, despite progress being reported from the conference, Termeer and Sanofi Aventis CEO Chris Viehbacher haven’t met face-to-face to discuss the terms of a possible deal. However, Viehbacher did mention that Sanofi was “still committed” to purchasing Genzyme.

Stay tuned for the next installment of the saga.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

 

Merck Gets Serious About Biosimilars

Two years ago Merck formed a new division called BioVentures ostensibly to develop and manufacture biosimilar drugs. Interestingly, the announcement preceded creation of a regulatory approval pathway for biosimilars in the US.  While the approval pathway still isn’t in place, many regulatory experts expect the US government to issue the guidelines by mid-2011 after a meeting that was held on biosimilars by the US Food and Drug Administration last month.

Late last year, the company scuttled its plan to develop a PEGylated version of EPO which was to be its first so-called biosimilar. Unfortunately, PEG-EPO would not be allowed to be approved as a biosimilar via any existing or newly divined pathway because it is actually a new molecular entity and, therefore, would require numerous clinical trials to garner regulatory approval (maybe that is why Merck canceled development).

Nevertheless, Merck expects to have no fewer than 5 biosimilar molecules in clinical development by 2012. To that end, Merck  that it had created an alliance with Parexel International Corp—a global clinical research organization—to help to conduct the clinical trials necessary for regulatory approval of the biosimilars that Merck is developing. The financial terms of the deal were not disclosed.

Michael Kamarck, President of Merck BioVentures, declined to specify the products but did mention that the terms of the deal terms were intended to “motivate Parexel to enroll patients quickly and generally execute the clinical trials in a speedy fashion.” He also noted that the Parexcel deal is only “one of an number of strategic steps: that Merck is pursuing in the biosimilar field.

Let’s see whether or not Merck can meet the lofty goals that it has set for itself. Hopefully biosimilar legislation will be in place by 2012!

Until next time....

Good Luck and Good Job Hunting!!!!!!!

 

Merck Cuts Sales Force in 2010 but Revenues Continue to Rise

In press release today, Merck & Co disclosed that it reduced the size of its global sales force by 12 percent in 2010. Ken Frazier, Merck’s newly appointed CEO, pointed out that cuts in sales force sizes in developed markets like the US and Europe reached almost 30 percent. Yet, despite these cuts, Merck reported that it was able to boost sales in its vaccine and pharmaceutical business units.

Merck, like most other big pharmaceutical companies, have drastically reduced the sizes of their sales forces in recent years. The cuts have been attributed to higher than expected product attrition rates, product recalls and changes in physician preferences. It appears that many physicians grew tired of repeated visits by multiple reps after they were no longer allowed to give gifts or buy lunches for physician office staff. Further, many industry analysts contend that the advent of web-based marketing, social media and medical reimbursement overhaul (doctors no longer have time for reps) have largely rendered most pharmaceutical sales reps obsolete!

Other factors contributing to the recent demise of pharma reps are thin drug development pipelines, tougher regulatory standards for drug approval and impending patent cliffs (generic encroachment) for many blockbuster small molecule drugs. Put simply, fewer drugs require fewer people to sell them.

I think the death knell for pharma reps may be a bit premature. Many physicians find that well trained and informed sales rep can be a great resource and helpful to their practices.  Nevertheless, looking on the bright side, there is a growing need for sales reps that possess the background and training to sell biotechnology products! That said, unemployed pharma reps may want to consider going back to school to get some biotechnology training. This training is frequently available at local community colleges and four year colleges and universities and online.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

 

What to Look for From FDA in 2011

The US Food and Drug Administration (FDA) is one of those federal agencies that everyone loves to hate. Sometimes I think the FDA is more vilified than the Internal Revenue Service! Nevertheless, FDA’s mission is to provide the American public with safe and efficacious foods, medicines and cosmetics. And, despite some highly publicized missteps like Vioxx and Avandia in recent years, the agency has done a great job since it was created in 1930.

Mark Senak, who writes the always interesting and incisive EyeonFDA blog, published a piece outlining what consumer may expect from FDA this year. The highlights on his list include:

  • Draft guidance regarding the Internet and the use of social media
  • Increased enforcement of social media in the life sciences industry
  • Renewed interest on divining a legal, regulatory approval pathway for biosimilars

While none of these items is new, one can only hope that the agency can finally deliver on implementing these policies.

Until next time...

Good Luck and Good Job Hunting!!!!!

 

The Cacao Genome (Chocolate) Sequencing War Revisited

Previously, BioJobBlog reported on the race between two groups led by the Mars and Hersey companies to sequence and decode the cacao (chocolate) tree genome. It should come as no surprise that the world’s two largest chocolate companies have pitted themselves against one another to decode the wonders of the cacao bean. After all, chocolate is big business and learning how to maximize yields, improve flavors and optimize the levels of cacao bean chemical components would be a boon to the company that was able to obtain the genetic information first!

Currently, most cacao farmers earn about $2 per day, but producers of fine cacao earn more. Increasing the productivity and ease of growing cacao can help to develop a sustainable cacao economy. The trees are now also seen as an environmentally beneficial crop because they grow best under forest shade, allowing for land rehabilitation and enriched biodiversity. Today, many growers prefer to grow hybrid cacao trees—rather than the original variety Theobroma cacao, Criollo)—that produce chocolate of lower quality but are more resistant to disease. Roughly five percent of the world’s current cocoa production is derived from Criollo cacao beans because of increased susceptibility to fungal diseases which results in higher costs and lower yields.

At the last installment of this ongoing saga, the Mars group, September 2010, released a statement that that they had beat the Hershey group and unraveled DNA sequence of the most common cacao bean variety that is used to manufacture most commercial chocolate.

The Mars researchers constructed a preliminary genomic map that covered over 70 per cent of the total cacao bean DNA sequence which is distributed over 10 chromosomes. These data were uploaded to The Cacao Genome Database which is publicly available as long as persons who access the data sign an agreement that stipulates that they “will not seek any intellectual property protection over the data, including gene sequences contained in the database. The Information Access Agreement allows any cacao breeders and other researchers to freely use the genome information to develop new cacao varieties.”

While the Mars group may have beat the Hersey group to the popular press, their research has not yet appeared in an academic journal for scientific scrutiny. Interestingly, the Hersey group yesterday announced that their version of the cacao genome was published in the most recent edition of Nature Genetics. According to the authors,

We sequenced and assembled the draft genome of Theobroma cacao (Criollo), an economically important tropical-fruit tree crop that is the source of chocolate. This assembly corresponds to 76% of the estimated genome size and contains almost all previously described genes, with 82% of these genes anchored on the 10 T. cacao chromosomes.

Analysis of this sequence information highlighted specific expansion of some gene families during evolution, for example, flavonoid-related genes. It also provides a major source of candidate genes for T. cacao improvement.

While Theobroma is often used to manufacture gourmet chocolates that particular variety of cacao tree often remains vulnerable to disease. Information gleaned from this study could be used to breed bioresistant varieties of Theobroma.

Further the authors noted:

Our analysis of the Criollo genome has uncovered the genetic basis of pathways leading to the most important quality traits of chocolate--oil, flavonoids and terpene biosynthesis […] It has also led to the discovery of hundreds of genes potentially involved in pathogen resistance, all of which can be used to accelerate the development of elite varieties of cacao in the future.”

Other genes that were identified include those for the production of cocoa butter, natural antioxidants, hormones, pigments, and aromas. BTW, for those of you who may be interested, cocoa was thought to be domesticated about 3,000 years ago in Central America; making it one of the world’s oldest domesticated tree crops.

It isn’t clear yet how the cacao genomes deciphered by the Mars and Hersey groups match up against one another. Regardless, the big winners here are chocolate lovers. What to you think the world stance will be on genetically engineered chocolate? 

Oy!

Until next time...

Good Luck and Good Eating!!!!!

 

More Women Needed For Math, Science and Engineering Jobs

Most job pundits and career analysts believe that millions of jobs will become available in science, technology, engineering and math (STEM) by 2018. Yet, despite ongoing initiatives the next generation of American employees may be unprepared and not qualified to take advantage of these new opportunities. A recent report from the Information Industry Technology Council, indicate that US children are falling behind their international peers in all aspects of STEM education!

Further, the US Bureau of Labor Statistics reports that although women currently make up more than 50 percent of the American workforce, they hold only 14 percent of all engineering positions and 25 per cent of mathematics positions. While it previously was believed that women were less academically-capable in STEM disciplines, new data clearly shows this not to be the case. The differences in achievement only become apparent when lower expectations and distorted perceptions of likely success affect motivation levels and confidence. In other words, there are no genetic differences between men and women that explain why there are disproportionately lower numbers of women in STEM jobs. 

With fewer men and increasing number of women graduating from college, it is incumbent upon STEM educators and employers to devise new strategies to encourage and help women purse careers in science, math and engineering. Like it or not, women will have a significant role to play in the future when it comes to American ingenuity and innovation. 

The “gold ole boys” days are thankfully drawing to a close and will continue to do so as we move further into the 21st century.

Until next time...

Good Luck and Good Job Hunting!!!!!! 

 

Study Finds Pharma Wrongdoing on the Rise

In a first-of-its-kind study, researchers at the Public Citizen’s Health Research Group tracked the civil and criminal financial penalties levied against the pharmaceutical industry for wrongdoing over the past 20 years. 

The main findings of the study revealed:

  1. Of the 165 settlements comprising $19.8 billion in penalties during this 20-year interval, 73 percent of the settlements (121) and 75 percent of the penalties ($14.8 billion) have occurred in just the past five years (2006-2010).
  2. Four companies (GlaxoSmithKline, Pfizer, Eli Lilly, and Schering-Plough) accounted for more than half (53 percent or $10.5 billion) of all financial penalties imposed over the past two decades. These leading violators were among the world’s largest pharmaceutical companies.
  3. The practice of illegal off-label promotion of pharmaceuticals has been responsible for the largest amount of financial penalties levied by the federal government over the past 20 years. This practice can be prosecuted as a criminal offense because of the potential for serious adverse health effects in patients from such activities.
  4. Deliberately overcharging state health programs, mainly Medicaid fraud, has been the most common violation against state governments and is responsible for the largest amount of financial penalties levied by these governments. This type of violation is also the main factor in the considerable increase in state settlements with pharmaceutical companies over time.
  5. Former pharmaceutical company employees and other “whistleblowers” have been instrumental in bringing to light the most egregious violations and have been responsible for initiating the largest number of federal settlements over the past 10 years. From 1991 through 2000, qui tam (whistleblower) cases made up only 9 percent of payouts to the government, but from 2001 through 2010, they comprised 67 percent of total payouts.

The companies, their missteps and the fines imposed are shown below:

The authors conclude:

"Over the past two decades, especially during the past 10 years, there has been a marked increase in both the number of government settlements with pharmaceutical companies and the size of the accompanying financial penalties. Given the relatively small size of current financial penalties when compared to the perpetrating companies’ profits, both increased financial penalties and appropriate criminal prosecution of company leadership may provide a more effective deterrent to unlawful behavior by the pharmaceutical industry."

Interestingly, about a month ago officials at the US Food and Drug Administration signaled that were willing to prosecute company executives to the fullest extent possible (including criminal prosecution) to reduce the incidence of fraud, off-label marketing and manufacturing violations that have become commonplace in the pharmaceutical industry in the past five years.

Until next time....

Good Luck and Good Job Hunting!!!!

Sanofi-Aventis' Oncology Push

It is no secret that Sanofi-Aventis is facing a steep “patent cliff” in 2013 when some of its top selling drugs, most notably Plavix, will lose patent protection. Some analysts contend that the company can lose as much as a quarter of its annual revenue because of generic encroachment on blockbuster brands. Sanofi is narrowing its business to three areas -- diabetes, heart problems, and cancer -- and is seeking partnerships and acquisitions.

This past June, Sanofi inked a $398 million deal with US-based Ascenta Therapeutics to gain access to two experimental cancer drugs that are in preclinical development. Later that month, the company purchased TargeGen a privately held US biopharmaceutical company focusing on oncology R&D. Two months later, Sanofi announced that it had entered into a partnership with the Belfer Institute of Applied Cancer Science (part of the Dana Farber Cancer Institute) to gain access to additional experimental cancer treatments.

Today, Sanofi announced that it had reached an agreement with Germany-based  Merck KGaA to jointly study experimental cancer treatments. Both companies Merck will conduct early stage human trials of Merck’s MSC1936369B and Sanofi’s SAR245409 and SAR245408 experimental drugs. Under the terms of the agreement, each company will carry out an early-stage dosing test of the drug candidates. Sanofi will be granted a license to study the safety and effectiveness of the Merck compound when used with SAR245408. Merck will be given a license to work with Sanofi’s other medicine to study its use in combination with its experimental compound. Financial terms of the deal were not disclosed.

Yesterday, Sanofi announced that it had signed an agreement with Oxford University to conduct multi-phase clinical and translational research in oncology with INDOX, a network of cancer research centres established across India in partnership with the university's Institute of Cancer Medicine five years ago. According to the terms of the agreement Sanofi-Aventis has agreed to provide financial support to Oxford University in managing the INDOX network of eight cancer research centres across India. 

Based on this spate of activity over the past six months it would appear that Sanofi is executing its new long term strategic plan. Stay tuned for more news!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

 

Mirror, Mirror on the Wall Who's the Most Ambitious Big Pharma Company of Them All?

Since I don’t have a magic mirror, I can only go on what I read in the Internet. And, it appears that Roche may be the most ambitious pharma company of them all; at least by 2013. According to a post on PharmLive, “Roche’s late-stage pipeline is progressing well with potentially ten regulatory submissions of new molecular entities until the end of 2013.”

So what drugs make up this rather full pipeline?

  1. T-DM1 (trastuzumab-DM1)-antibody-drug conjugate for Her-2 positive breast cancer
  2. Pertuzumab/trastuzumab (Herceptin)-monoclonal antibody cocktail to treat Her-2
  3. positive breast cancer
  4. MetMab-a unique monovalent monoclonal antibody for non-small cell lung cancer
  5. GA101/RG7159-the first glycoengineered type II humanized anti-CD20 monoclonal for relapsed/refractory progress non-Hodgkins lymphoma
  6. RG7204-anti-BRAF protein monoclonal antibody for BRAF-mutation-positive metastatic lung cancer
  7. RG1678-first-in-class glycine reuptake inhibitor that normalizes glutamate neurotransmission for schizophrenia and other psychiatric indications
  8. RG1594 (ocrelizumab)-humanized anti-CD20 monoclonal for multiple sclerosis

Not surprisingly, many of these molecules were developed at Genentech, the world’s largest biotechnology company that was purchased by Roche almost two years ago.

Until next time...

Good Luck and Good Job Hunting!!!!

 

Tis the Season....Pfizer's CEO Abruptly Announces His Departure

Late last week, Merck appointed Ken Frazier, a lawyer, to be the company’s next CEO. Frazier’s appointment, while expected, was historical because he was the first African American tapped to be the CEO of a major pharmaceutical company. Industry insiders contend that Frazier’s unlikely ascension is a tribute to his affability, PR prowess and ability to successfully use his considerable legal skills to navigate Merck through its troubled Vioxx era. 

On the other hand, industry analysts and Pfizer shareholders have been less enamored of the performance of Jeffrey B. Kindler, another lawyer, who has led the company since 2006 when its former CEO Hank McKinnell Jr tried to single-handedly destroy the world’s largest drug maker. Kindler joined Pfizer in 2002 as its chief counsel after working at General Electric and McDonalds—clearly a man with little or no previous pharmaceutical industry experience. While critics contend that Kindler did a laudable job after stepping into the breech, there was consensus among a majority of Pfizer shareholders that it was time for a change at the top.

In a statement Sunday, Kindler announced that he wanted to “recharge my batteries, spend some rare time with my family and prepare for the next challenge in my career.” During his tenure, Kindler oversaw the acquisition and merger of Pfizer and Wyeth and successfully oversaw a settlement for illegal marketing of the painkiller Bextra which included a $1.3 billion criminal fine: the largest health care fraud case and criminal fine for a pharmaceutical company in US history.

The reason for Kindler’s unexpected and sudden departure is likely the impending patent expiry (2011) for its top selling cholesterol drug Lipitor (Pfizer acquired Lipitor after purchasing Warner Lambert Pharmaceuticals in the mid 1990s). Recent financial reports indicate that Lipitor accounted for $11.4 billion of Pfizer’s $50 billion in sales last year or 23% of its revenue. Most industry analysts agree that navigating Pfizer in a world without Lipitor will require an individual with many years of pharmaceutical industry experience and moxy.

To that end, Pfizer announced that Ian Read, currently head of the company’s biopharmaceutical operations will immediately take over as CEO. According to a profile on Forbes.com, Read is:

Senior Vice President; Group President, Pfizer Biopharmaceutical Businesses since October 2009. Previously, he was President Worldwide Pharmaceutical Operations from August 2006 until October 2009. Mr. Read has held various positions of increasing responsibility in pharmaceutical operations. He previously served as Area President for the Europe, Canada, Africa and Middle East and Latin America regions and Senior Vice President of the Pfizer Pharmaceuticals Group. Mr. Read was elected a Vice President of Pfizer Inc. in April 2001.

Also, Pfizer’s board of directors said that it would elect a new chairman (another position vacated by Kindler’s departure) at a meeting within the next two weeks.

Until next time...

Good Luck and Good Job Hunting!!!!

 

Merck Taps Ken Frazier as Its New CEO--The First African American to Lead a Major Pharmaceutical Company

Merck has finally gone where no pharmaceutical company has ever gone before; it today named Ken Frazier, a Harvard-trained African American lawyer as its next CEO. Frazier, who joined Merck in 1992, became general counsel in 1992 and was promoted to President of Global Human  Health last April will succeed Dick Clark (the other one) who will soon reach Merck’s mandatory retirement age of 65. Frazier has always been something of a rising star and his stock (pun intended) has rapidly risen in recent years mainly because of the prominent role he played in managing the fallout from the Vioxx scandal.

While today’s announcement may have been history making, Frazier’s ascension to the top position at Merck was widely expected. Frazier has played a key role in the integration of Schering Plough, which Merck purchased almost two years ago for $42 billion.

Like Clark, Frazier is not a scientist. Given Merck’s thinning pipeline and recent setbacks with its anti-cervical cancer vaccine Gardasil, Frazier, like Clark will have his work cut out for him to restore Merck’s tarnished image to its once impeccable standing in the pharmaceutical industry.

Until next time...

Good Luck and Good Job Hunting!!!!!!

 

Move over China and India: Big Pharma Is Eyeing Brazil

Most major pharmaceutical companies left Brazil about 30 years ago. However, much has changed in the country over the past 30 years and most western pharmaceutical companies are rushing back into Brazil to expand their operations and make acquisitions. At the same time, many Brazilian drug makers are beginning to consolidate and spread abroad.

The exodus of multinational drug companies in the 1980s was prompted by high inflation, tough government-mandated price controls and the lack of strong intellectual property and patent laws. Over the past 20 years Brazil has become a leader in agricultural technologies and made substantial investments into biotechnology. Along with these gains, patent rules and regulatory rules for pharmaceuticals and generics have become much stricter; making Brazil much more attractive to most major pharmaceutical manufacturers as growth of established markets continues to slow and need to increase sales in developing markets is critical. At present, Brazil is the eight largest eighth-largest drug markets in the world by sales. Much of this growth has been spurred by the rapid growth of the middle class (remarkably without reimbursement from state or private health insurance).

Some of the drug makers that have already invested in Brazil include Novo Nordisk, Sanofi-Aventis, Pfizer and Astra Zeneca. Novo Nordisk was an early entrant with its purchase in 2001 of Biobrás, a large insulin production plant outside São Paulo. Last year, Sanofi-Aventis acquired Medley, growing its portfolio of over-the-counter and branded products to complement its own offerings. Last month, Pfizer bought 40 per cent of Teuto, another generics business; other US, European and Japanese companies are continuing to study the Brazilian market closely.

While many western companies have gained a foothold in Brazil through M &A activity, others are attempting to develop their own internal presence.  Astra Zeneca, for example, is preparing for a launch of a series of both branded and generic products in the country.

In addition to the growing interest of multinational companies, some of Brazil’s domestic drug makers have been active. For example, Aché, a family-owned group and one of Brazil’s largest branded generics producers, has made smaller domestic acquisitions, and was considering buying Medley. The company has also begun forging alliances across Latin America, while its rival Eurofarma earlier this year bought Laboratorios Gautier in Uruguay, as the groups seek economies of scale in manufacturing and sales across the region. Even Farmaguinhos, the state-owned Brazilian drug company, has been collaborating with the African nation Mozambique.

Although the Brazilian government has made sizeable investments into research units such as the Butantan Institute in São Paulo and Oswaldo Cruz in Rio de Janeiro, the Brazilian drug industry is still in its infancy. The question is whether or not domestic drug makers will be able to meet demand before they are acquired by foreign companies interested in making inroads into Brazil’s burgeon drug market.

Until next time….

Good Luck and Good Job Hunting!!!!!!

 

Sam Waksal, PhD: A Phoenix Rising

Sam Waksal, the former Founder and CEO of ImClone Systems who was convicted in 2003 of insider stock trading and spent about five years in prison is trying to make a comeback as a biotechnology entrepreneur.

Shortly after his release from prison, Sam started a new, privately-held, biotechnology company called Kadmon (a moniker taken from the Kabbalah). He reportedly was able to raise over $50 million in venture capital (much of it allegedly coming from Carl Icahn a long time investor, business partner and friend.*

Kadmon which has been operating in stealth mode for the past two years today announced that it had acquired Three Rivers Pharmaceuticals, a privately held company in Warrendale, PA that develops and sells drugs to treat hepatitis C infection. Three Rivers was acquired to provide Kadmon with an ongoing source of revenue to help develop other drugs. It sells versions of the drugs alpha interferon and ribavirin, mainstays of hepatitis C treatment.

According to a company spokesperson, Kadmon acquired Three Rivers for over $100 million. Previously, Kadmon quietly acquired PhytoCeutica a company developing a cancer drug derived from traditional Chinese medicine and Flux Therapeutics a company co-found by Thomas E. Shenk, PhD a Princeton University virologist. Coincidentally, Dr. Shenk works in the Carl Icahn Laboratories at Princeton University.

Despite his conviction for insider trading, Sam is a seasoned and successful biotechnology entrepreneur who almost single handedly brought the blockbuster anti-cancer drug Erbitux to market. Sam who has a PhD degree in Immunology from Ohio State University and  has a "leg-up" on many biotechnology entrepreneurs because he understand both science and business.  As you may recall, ImClone System (the company that he founded in the 1980s) was sold two years ago to Eli Lilly for $6.5 billion—a deal brokered by ImClone’s Chairman, Carl Icahn. 

Interestingly, Sam is prohibited by a settlement he made with the Securities and Exchange Commission from serving as a director or executive of a publicly traded company. It will be interesting to see whether or not Kadmon decides to remain private. I suspect that won’t be the case if the IPO window opens up a bit more over the next few years. Once biotechnology companies go public, there is no longer a need for entrepreneurial founders like Sam to stick around!

Until next time...

Good Luck and Good Job Hunting (try Kadmon, they have lots of cash)

 * An NY Times article published on Nov 1, 2010 contends that Carl Icahn had initially considered investing $30 million in Kadmon but ultimately decided to pass.

Will the Next Blockbusters be Treatments for Rare Diseases?

The era of blockbuster drugs was officially declared over several years ago by many pharmaceutical analysts and pundits. Nevertheless, as the old adage goes “it’s difficult to treat old dogs’ new tricks!” After all, the blockbuster drug model has been the major driver of pharmaceutical and biotechnology markets for close to 50 years. Consequently, big pharma and biotech companies haven’t truly abandoned the possibility of finding potential new blockbusters. And, it appears that the blockbuster heir apparent may be drugs to treat rare aka orphan disease indications. 

At first blush, this strategy may not make a lot of sense. This is because rare diseases afflict only small numbers of patients (at least in the US and other Western nations). However, what may be considered a rare disease in Europe or the US may actually be less rare in countries with large populations like China and India. Further, while current rare diseases patient populations may be small, the cost of the drugs developed to treat them is extremely high. In some instances, the annual cost per patient can exceed several hundred thousand dollars. If you do the math, it becomes apparent that developing rare disease treatments or so-called niche busters can actually be very big business. 

The rare diseases business model has been perfected by Genzyme and many big pharma companies are trying to emulate it. To that end, big pharma’s push into rare diseases continues to gather momentum. So far this year Sanofi-Aventis has made an $18.5bn move for Genzyme, while Pfizer and GlaxoSmithKline have both created rare disease business units.

According to Glaxo’s estimates, 7,000 rare diseases have been identified and collectively this affects 6-8% of the world’s population; in the US and Europe alone rare diseases affect 25 million people. In addition mortality rates are very high, often at a very young age, and less than 10% of these diseases are treated with approved drugs.

To date, over 7,000 rare diseases have been identified. Companies involved in the new rare diseases treatment race have whittled the list down to roughly 200-250 disorders that represent a clear path for clinical, regulatory and commercial success. The criteria used to select these indications include identifying rare disorders with: 1) a relatively high prevalence rate, 20 an early age of onset, 3) a large unmet medical need and 3) a known molecular target. The indications have been broadly classified into four distinct groups:  metabolic disorders, autoimmune/inflammation, central nervous system and blood disorders.

While Genzyme identified, developed and commercialized its rare diseases treatments, it is likely that big pharma companies like Pfizer, Glaxo, and Merck will either in-license potential new treatments or acquire companies with platform technologies or drugs in various stages of clinical development. For example, Merck’s acquisition of Glycofi several years ago has allowed the company to enter into the rare diseases and biosimilar markets.

One of the major problems with extant rare diseases treatment is their excessive and oppressive costs. One can only hope that the increased competition in the rare diseases space will help to lower drug prices and make them more affordable for patients who suffer from these devastating and life-threatening disorders.

For more insights in to the orphan drug disease market, check out an article that I wrote for Life Science Leader this month

Until next time...

Good Luck and Good Job Hunting!!!!!

 

The BioCon-Pfizer Deal: Pfizer Embraces Biosimilars?

Biocon, one of India’s leading biopharmaceutical companies today announced that they have entered into a strategic global agreement for the worldwide commercialization of Biocon's biosimilar versions of Insulin and Insulin analog products:  Recombinant Human Insulin, Glargine, Aspart and Lispro.  

As part of the deal, Pfizer will have exclusive rights to commercialize these products globally, with certain exceptions, including co-exclusive rights for all of the products with Biocon in Germany, India and Malaysia.  

Biocon will continue to assume responsibility of clinical development, manufacture and regulatory approval of these products in various geographical regions and countries. Biocon's recombinant human insulin formulations are approved in 27 countries in developing markets, and commercialized in 23. Glargine’s first market was India where it was recently launched.  

Under the terms of the agreement, Pfizer will make upfront payments totaling $200 million.  Biocon is also eligible to receive additional development and regulatory milestone payments of up to $150 million and will receive additional payments linked to Pfizer's sales of its four Insulin biosimilar products across global markets.

While both Biocon and Pfizer are pushing the biosimilar aspect of the deal, it is important to point out that recombinant insulin are approved as “drugs” not biologics in the US. Consequently, these products are not true biosimilars and qualify for ANDA approval in the US. That said, it is intriguing that Pfizer is willing to be portrayed as a company that endorses the use of biosimilar medicines. Interestingly, however, there is still no regulatory approval for biosimilars in the US. And, despite public assertions to the contrary, most major pharmaceutical and big biotech companies are fiercely opposed to the introduction of biosimilars to the US. To that end, the current biosimilar legislation recently approved by Congress will prohibit the US introduction of biosimilars until approximately 2020.  

To date, more than 10 biosimilars have received marketing authorization in the EU and other Western markets. Europe approved a regulatory pathway for approval of biosimilars in 2004. Biosimilars have been sold in the so-call gray, unregulated markets in Asia, South America and elsewhere for the past decade.

Until next time...

Good Luck and Good Job Hunting (try India, they are hiring)

 

A New Wrinkle for Botox

Late last week the US Food and Drug Administration (FDA) approved Botox, Allergan’s anti-wrinkle injection, as a treatment to prevent chronic migraine headaches. Botox is already approved to treat uncontrolled blinking; crossed yes; certain neck muscle spasms; excessive underarm sweating; and stiffness associated with muscle spasticity in the elbows and hands. However, Botox is approved and largely used for cosmetic purposes—to smooth wrinkle lines on the forehead and between the eyebrows. Interestingly, a little less than a month ago Allergan paid $600 million to settle allegations that it had illegally marketed Botox for unapproved indications like headaches for years.

Botox had worldwide sales last year of approximately of $1.3 billion which is thought to be divided equally between medical and cosmetic uses. Allergan believes that its use for treating chronic migraines will quickly outstrip and eclipse Botox use as an anti-wrinkle treatment. While much money has been invested in developing treatments for chronic migraine sufferers, there are very few effective treatments currently on the market. Botox is also being investigated as a treatment as a treatment for overactive bladder; a huge and quickly emerging market directly related to an aging population.

Financial analysts predict that sales of Botox as a treatment for chronic migraines could range from $250 to $1.0 billion per year by 2015.

While the treatment may help patients with chronic migraines, it is a fairly painful one that requires a total of 31 injections in seven areas—the forehead, temples, back of the head, neck and shoulders. And, injections are given every three months. The cost of each treatment is expected to range from $1000 to $2000 which may inhibit its uptake unless private insurers cover much of the cost. Also, some critics argue that the treatment is no better than placebo in reducing the incidence and severity of migraines.

Nevertheless, whether or not Botox works to control migraine headaches, patient who receive the treatment will likely look much younger—not that there is anything wrong with that!

Until next time...

Good Luck and Good Job Hunting (younger-looking people have an easier time of it!)

Big Pharma Merger-Mania Continues at a Brisk Pace

I am certain that many of you may have noticed that the size of the life sciences industry is shrinking at an unprecedented rate. Big pharma companies flush with cash, near- empty pipelines and impending patent cliffs have embarked on a buying spree that is likely to continue for next years (or at least until the economy shows clear signs of resuscitation). Pfizer’s impending acquisition of King Pharmaceuticals is just another transaction in a long list of M&A deals that have occurred over the past three years.                             

According to an article in today’s NY Times, roughly $42.2 billion worth of pharma deals have been transacted so far this year. That number is close to the $45.8 billion in M&A transactions announced by the same time last year (excluding Pfizer’s acquisition of Wyeth and Merck’s purchase of Schering Plough). Unfortunately, these mega-merger deals almost always result in massive layoffs in the industry.

While blockbuster mergers may not be good for pharmaceutical employees, the behind the scenes players—investment bankers, brokers, advisers and consultants—make out extremely well. For example, according to an article in Pharmaceutical Technology Europe, over a three month period in 2009 pharmaceutical company merger and acquisition activities generated $500 million in advisory fees for investment bankers. Clearly, mergers and acquisitions are in the best interest of company executives and the investment bankers not pharmaceutical employees.

There is no question that the recession and the down economy are driving much of the M&A activity in the life sciences sector. And, industry consolation is to be expected during challenging economic times. However, while M&A may be in the best interest of pharma company shareholders in the short term, I don’t think it will help to insure American competitiveness and innovation in the life sciences over the long term. 

Until next time...

Good Luck and Good Job Hunting

Pfizer to Purchase King Pharmaceuticals

Pfizer today announced that it will purchase Bristol, TN-based King Pharmaceuticals for $3.6 billion in cash or $14.25 per share: an approximately 40% premium over King’s closing share price yesterday.

King is a diversified specialty pharmaceutical drug delivery and clinical development company with expertise in delivery of easy to abuse or misuse pain medicines, self injecting delivery devices and animal health

The acquisition will help Pfizer push forward with its new emphasis on biopharmaceuticals and rare disease drugs; both currently require parenteral administration to patients.

The King acquisition is consistent with Pfizer’s M&A strategy to enter new therapeutic areas and markets. In the last 10 years or so Pfizer has acquired Warner Lambert, Pharmacia, Wyeth and several smaller companies including Sugen, Copely Pharmaceuticals, Encysive Pharmaceuticals, Serenex and others.

Whether or not Pfizer can successfully integrate King’s expertise and business units into its existing monolithic corporate structure remains to be see. Pfizer is still trying to right itself after it acquired Wyeth Pharmaceuticals for $65 billion early last year.

Big pharma companies—flush with cash—have been on a buying spree of late. Unfortunately, the availability of this cash is directly related to the massive downsizing and layoffs that have taken place in the industry over the past few years. That said, if I were a King employee, I would be dusting off my resume!

Until next time

Good Luck and Good Job Hunting

 

FDA Update: Product Recalls, Social Media and Biosimilar Guidelines

Whether you like President Obama or not, the changes he made in the leadership at the US Food and Drug Administration (FDA) is beginning to yield results. After just two years, the agency is well on its way to modernization and overcoming its descent into the dark ages during the failed Bush Administration.

Mark Senak, the intrepid author of the EyeonFDA blog has been assiduously following and blogging about many of the new things going on at the agency. First, in a post a last week, Mark noted that FDA has updated its website and created a product recall page that collects recall information on all of the products that it regulates and deposited it in an easy to find product recall page. With product recalls in the food and life sciences industry increasing in frequency, this page will help to alert consumers about tainted products before learning of them on the nightly news. 

Second, Mark points out that FDA has finally entered the 21st century and is now fully engaged in social media.

“FDA begins to join the 21st Century launching a Facebook page that has been long anticipated on this blog. FDA has not completed the Social Media Quadrant - (1) a blog, (2) several twitter feeds (3) a YouTube channel, and (4) a Facebook page.  And as added good measure, the agency opened a Flickr page.  The agency is now fully engaged in activities that many in the industry it regulates think is forbidden them.... And the beat goes on.”

Finally, earlier this week FDA announced that it would hold long-awaited public hearings to get input on proposed biosimilar regulatory guidance. As Mark duly notes, this process is likely to be contentious and protracted.    

"The FDA has set November 2-3 for a meeting to get input on a wide span of questions regarding the development of a regulatory pathway for biosimilars.  The scope of the questions is demonstrative of the number of outstanding issues the agency faces and will likely result in a protracted process. "

Central to the debate (and ultimate success of biosimilars) is the question of interchangeability and substitution of name brand products with biosimilar molecules. According to Mark, the agency will focus on the following questions

"What factors should the agency consider in determining whether a proposed interchangeable biological product can be "expected to produce the same clinical result as the reference product in any given patient?"

"What factors should the agency consider in evaluating the potential risk related to alternating or switching between use of the proposed interchangeable biological product and the reference product or among interchangeable biological products?"

What has become patently obvious to many of us who have been following the debate over the last decade is that unless biosimilars are interchangeable or substitutable for brand name biologics, the commercial success of the biosimilar industry may be in serious jeopardy. Put simply, there is no question that safe and effective biosimilars can be manufactured; the real question is whether or not physicians will prescribe biosimilar products if they are required to be branded by regulatory agencies. This is because physicians are reluctant to switch patients to new biologic products if a patient is doing well on a currently prescribed regimen. Since most physicians pay little attention to drug pricing, it is highly unlikely that they will switch a patient to product simply because there may be a 20 percent reduction in drug price. And, unless biosimilar products are deemed interchangeable with their branded counterparts, pharmacists (based on insurance formularies) will not be able to offer patients a generic equivalent of a name brand biologics. 

With the cost of biologic treatments skyrocketing, it will be interesting to see what the agency will do with this question.

Until next time...

Good Luck and Good Job Hunting!!!!!!

 

Off Label Marketing by Pharmaceutical Companies was Pervasive in the early 2000s

The pharmaceutical industry, not unlike all big business during the disastrous Bush Administration, was virtually unregulated. Bush and his cronies managed to accomplish this feat by destabilizing the US Food and Drug Administration (FDA) and essentially hamstringing any regulatory authority that it had. Not surprisingly, many pharmaceutical companies saw an opportunity to increase their bottom lines by engaging in off label marketing of many of their approved drugs—a practice clearly forbidden by the agency. 

Despite the fact that off label marketing is illegal, many big pharma companies knowingly and willfully engaged in the practice. Luckily, the Obama administration has reinvigorated and restored the regulatory powers at the agency and FDA is now aggressively investigating and punishing companies that had promoted off-label use of their products over the last decade.

The New York Times today reported that Novartis joins a growing list of pharmaceutical companies that have settled government investigations into health care fraud in the last few years, including Pfizer, which paid $2.3 billion; Eli Lilly, $1.4 billion; Allergan, $600 million; AstraZeneca, $520 million; Bristol-Myers Squibb, $515 million; and Forest Laboratories, $313 million. Pfizer, Lilly, Allergan and Forest pleaded guilty to crimes in the cases. The company was fined $422 million settle criminal and civil investigations into the marketing of the antiseizure medicine Trileptal and five other drugs. 

According to the article, the five other drugs involved in the civil settlement are Diovan, a hypertension drug that is the company’s top-selling product, at $6 billion last year; Sandostatin, a drug to treat a growth hormone disorder that had worldwide sales of $1.2 billion last year; Exforge, a hypertension drug that sold $671 million; Tekturna, a blood pressure medicine that sold $290 million; and Zelnorm, a medicine for irritable bowel syndrome and constipation that was later withdrawn from the United States market.

It is important to make a distinction between the practices of off-label drug use and off label marketing. As many of you may know, licensed US physicians are allowed to prescribe any FDA-approved drugs if they believe that their use will benefit patients. This is off-label drug use. However, in contrast, it is illegal for companies to actively promote or market approved drugs for therapeutic indications for which they have not received regulatory approval. This is off-label marketing and a strategy that has been used by companies to increase sales of approved products without having to spend money on expensive clinical trials that are required to prove safety and efficacy for a new drug to gain regulatory approval. While this may be a backdoor strategy for companies to boost product sales, it clearly puts patients at risk because the actual safety and efficacy for the indications has not been adequately tested and proven.

Many drug makers have been critical of FDA’s increase scrutiny of drug safety and have argued that it has negatively impacted the regulatory approval rates of new experimental medicines. While this may be troubling to many pharmaceutical executives, the FDA was created to insure that all approved drugs are safe and effective and the risk to Americans who use them is minimal. In other words, the agency is simply doing its job—something it was prevented from doing for the past eight years!

Until next time,

Good Luck and Good Job Hunting!!!!

 

The New Sequencing War: The Cocoa (Chocolate) Genome

A collaborative research team led by scientists at the candy maker (M&Ms, Snickers, Milky Way) Mars, the U.S. Department of AgricultureAgricultural Research Service (USDA-ARS) and IBM—announced this morning that they have successfully completed a preliminary cacao genome sequence, a map of the crop that supplies the majority of the world's cocoa for the manufacture of chocolate and other food products. The Mars group announcement upstaged a second research group—a consortium composed of Hershey, Pennsylvania State University and the French government—that was working furiously to complete its version of the cocoa sequence. BioJobBlog covered the initial announcement about the sequencing project made by the Mars group back in 2008.

While the race to sequence the cocoa genome was not as intense and bitter as the one between Celera and the Human Genome Project to sequence the human genome, the competition between the Mars and Hershey to be the first to announce the completed genome had similar trappings. Initially, there had been discussions between the two groups to work collaboratively on the cocoa genome. But after some deliberation the Mars team decided to “go it alone.”

At present, about 70 percent of the world crop is grown in West Africa by millions of small growers. With the cocoa sequence in hand, scientists believe that they can use molecular biology to improve yields and create cocoa varieties that are more resistant to diseases. For example, a fungal disease known as witches’ broom almost decimated the entire Brazilian cocoa group several years ago. Improving yields and making cocoa more resistant to infection may help to bring the cost of cocoa-based products like chocolate in the future. Another benefit may be improving the taste or increasing the amount of anti-aging flavonoids found in chocolate.

The cocoa genome contains about 420 million base pairs as compared with the human genome which contains roughly 3 billion base pairs. The Mars group edged out the Hershey-led group because it started earlier and mainly relied on fast, second generation DNA sequencers made by Illumina and 454. While Mars can claim victory because it finished first, the Hershey-derived sequence will be valuable to corroborate Mars’ preliminary sequence. Like everything else in science, research results must be independently confirmed before they are accepted by the wider scientific community.

Hat tip to Mars and Hershey for insuring future of the world’s chocolate supply!

Until next time...

Good Luck and Good Eating (Neuhaus chocolate rocks)

 

Genzyme v. Sanofi-Aventis: The Plot Thickens

Yesterday, Genzyme announced it would cut about 1,000 jobs worldwide as part of a restructuring plan. In addition, company spokespersons indicated that the company may outsource some of the eliminated permanent position and impose a hiring freeze. As part of its restructuring plan, the company plans on eliminating about 10 percent of its 12,800-employee workforce by 2012. It is unclear how many of the 4,500 US employees will lose their jobs.

In addition to the job cuts, the company announced that it had agreed to sell its diagnostic testing unit (reproductive and genetic testing) to Laboratory Corp of America for $925 million in cash. Henri Termeer, Genzyme’s beleaguered CEO also announced that the company’s other two units, molecular diagnostics and pharmaceutical ingredient manufacturing on also on the block and will be sold.

While Termeer insists that the job cuts and sale of non-core business units has nothing to do with Sanofi-Aventis’ attempt to purchase the company, many analysts believe that these measures are being taken to induce Sanofi to sweeten its $69 per share takeover bid. The additional monies garnered from the layoffs and division sales, will allow Genzyme to strengthen its stock position and bolster its cash reserves to defend against a possible hostile takeover attempt by Sanofi. 

The demise of Genzyme, once one of the most highly regarded and ethical biotechnology company in the world is directly linked to manufacturing problems at its Boston-based facility. The ongoing and protracted quality problems at the plant resulted in a consent decree by the US FDA and penalties totaling about $175 million. As most quality experts will tell you, systemic quality control and assurance issues generally stem from a lack of commitment to quality by senior management; in this case Termeer! 

Despite repeated request for his resignation, Termeer, who has run Genzyme for the past 25 years or so, has steadfastly refused to relinquish his post. Instead of stepping down to save the company, Termeer has chosen to “take the ship” down with him; the sure sign of an out-of-touch CEO who apparently was willing to sacrifice the reputation and worth of a company for entirely self-serving reasons.

Until next time...

Good Luck and Good Job Hunting

 

Another One Bites the Dust: Bristol Myers Squibb to Acquire the Biotechnology Company Zymogenetics

The New York Times today reported that Bristol Myers Squibb (BMS) will acquire Seattle, WA-based Zymogenetics for $885 million or $9.75 per share. The two companies were jointly developing new medicines to treat hepatitis C infections. The $9.75 a share in cash represents an 84 percent premium to Zymogenetics closing stock price on Tuesday.

BMS executives must believe that the jointly-developed hepatitis C product, PEG-interferon lambda will be a winner because the company is usually reluctant to pay such high premium prices for acquisitions. The new PEG-interferon lambda product will have to compete against similar products PEG-Intron (peginterferon alfa-2b, Merck) and Pegasys (peginterferon alfa-2b, Roche) in a highly competitive hepatitis C treatment market currently dominated by Roche. Also, several companies, most notably Vertex Pharmaceuticals, have orally-bioavailable small molecule hepatitis C treatments in late stage clinical development. All of the PEGylated interferons must be administered via injection.

BMS has a variety of marketed treatments for HIV/AIDS and hepatitis B infections. These products, along with its market leading anti-clotting agent Plavix (co-marketed with Sanofi-Aventis) are facing fierce generic competition in the not-to-distant future.

The company’s acquisition of Zymogenetics is another step towards transforming BMS from a small molecule pharmaceutical company into a biotechnology-focused drug maker. In addition to PEG-interferon lambda, Zymogenetics is developing protein-based treatments for surgical bleeding (recombinant human thrombin), metastatic melanoma (IL-21) and atopic dermatitis (IL-31 mAb). 

Zymogenetics was founded in 1981 and is one of Seattle’s largest independent, publicly-traded biotechnology companies. Stay tuned as more consolidation continues in the biotechnology sector.

Until next time....

Good Luck and Good Job Hunting!!!!!!!

 

Sanofi-Genzyme Update: GlaxoSmithKline Isn't Interested

For those of you who can’t tear yourselves away from the ongoing, nail-biting Sanofi Aventis-Genzyme saga, the head of GlaxoSmithKline (GSK) R&D, Moncef Slaoui told a French newspaper that GSK will not “step in as a rival bidder for the US biotech Genzyme.”

Slaoui made his remarks at the christenings of a GSK research center in France. “An offer by GlaxoSmithKline for Genzyme does not make sense. It is too expensive” he said. Also, GSK already has a foothold in the orphan disease market through its partnership with JCR Pharmaceuticals. 

As negotiations between Sanofi and Genzyme began to stall over the $69 per share offer tendered by Sanofi, some analysts had predicted that a so-called white knight may enter the bidding war to drive the stock share price higher to the $75 per share wanted by Genzyme.

Today’s announcement by GSK likely produced a collective sigh of relief from Sanofi shareholders. Personally, I think Sanofi would be crazy to let this one get away; the deal is exactly what Sanofi needs to begin to compete in the lucrative biologics market. Until now, Sanofi’s focus has been almost exclusively on small molecule development.

Until next time..

Good Luck and Good Job Hunting!!!!!!!!!!

 

CEO Finally Admits that Genzyme is Up for Sale...At the Right Price!

The Boston Globe reported today that this morning Henri Termeer, the embattled CEO of Cambridge, MA based Genzyme acknowledged for the first time that company was indeed up for sale. However, he was quick to point out that the $69 per share or $18.8 billion takeover bid from Sanofi Aventis was insufficient.

Over the past few days, Sanofi Aventis’ CEO Christopher A. Viehbacher turned up the heat on Termeer; forcing him to possibly take Sanofi’s latest offer directly to Genzyme shareholders. While Termeer acknowledged that the company was for sale, he hinted that other companies may join the bidding war to get the $75 per share price that the Genzyme board is seeking. 

The Sanofi Aventis-Genzyme situation is beginning to resemble the Bristol Myers Squibb (BMS)-ImClone standoff of two years ago. As you may recall, Jim Cornelius—BMS CEO at the time—publicly and repeatedly offered a “low-ball” price ($62 per share) to purchase ImClone despite admonishments from Carl Icahn, ImClone’s Chairman. As negotiations stalled, Icahn told Cornelius that there were other suitors who were willing to pay a higher price to acquire ImClone. Surprisingly, rather than continuing to negotiate in good faith, Cornelius decided to call Icahn’s “bluff.” In less than a week, Eli Lilly purchased ImClone for $70 per share ($6.5 billion); the price that Ichan had previously and publicly asked for to purchase the company.

Many of you already know that Icahn holds a substantial minority Genzyme stock position and is represented by two current Genzyme board members. That said, if I were Sanofi’s Viehbacher, I would proceed with extreme caution in future negotiations. Like him or not, Icahn is a financial genius and second-to-none negotiating M&A deals. 

Maybe Viehbacher ought to contact Cornelius for advice? Oh yeah...Cornelius retired as CEO earlier this year but he is still Chairman of the BMS Board of Directors. Maybe it is worth a call?

Stay tuned for new developments as the saga continues.

Until next time...

Good Luck and Good Job Hunting!!!!!

 

Sanofi-Genzyme Offer Update: Show Us the Money!

As predicted by many industry insiders and Wall Street analysts, the Genzyme board may be  holding out for at least a $75 per share offer from Sanofi-Aventis.  Previously, Sanofi-Aventis offered Genzyme $69 per share despite clear signals from Genzyme's board and its shareholder that the proffered offer was inadequate.

The Genzyme board is likely under extreme pressure to hold out for the $75 per share price because that is the price being sought by its powerful and influential minority shareholders Carl Icahn and Ralph Whitworth.

Carl Icahn, no stranger to corporate buyouts, is a master at getting the price that he wants for the companies that he sells. He previously sold ImClone to Eli Lilly for $70 per share after Jim Cornelius, Bristol-Myers Squibb’s former CEO, refused to offer more than $64 per share of ImClone stock.

Conventional wisdom suggests that Sanofi will likely buy Genzyme for at least $75 per share if not more!

Stay tuned for updates!

Until next time..

Good Luck and Good Job Hunting!!!!!!!

 

Bringing Celebrities and Pharmaceutical Companies Together to Sell Prescription Drugs

I read a fascinating article today posted on MedEdNews Insider Blog about the formation of a new agency called Rx Entertainment that helps to match celebrities with direct-to-consumer advertising campaigns created by pharmaceutical companies. Admittedly, I hadn’t thought much about the matching process, but in the past I have posted a few rants about direct-to-consumer advertising (DTC), Brooke Shields hawking Latisse for Allergan and the Robert Jarvik Lipitor brouhaha.

So, the post about an entertainment agency that helps to match celebrities with DTC prescription drug advertising campaigns piqued my interest. The blog post was actually an interview that was conducted by the blogger with the founder of Entertainment Rx (I love the name)! The interviewer asked the Rx Entertainment founder for examples of her agency’s matching maker prowess.  The list (see below) is very impressive:

  1. Claire Danes and Brooke Shields for Latisse
  2. Food Network’s Ellie Krieger for Centecor in the area of arthritis
  3. Gretchen Wilson for LapBand
  4. Jennifer Lopez for childhood vaccines
  5. Vanessa Williams and Virginia Madsen for Botox
  6. Sally Field for Boniva
  7. Jim Belushi, Bruce Jenner, Danica Patrick, and Patty Loveless for COPD
  8. Keri Russell on a campaign for Sanofi-Aventis  on the Sounds of Pertussis vaccine campaign
  9. Angelica Huston to help launch the well-known Merck Manual
  10. Elisabeth Hasselbeck and Marg Helgenberger for a fundraiser sponsored by P&G  where all the proceeds went to breast cancer research
  11. Robert DeNiro to help launch a nicotine patch. He was premiering one of his films in NY and a fundraiser for cancer research was tied to the event.
  12. Dara Torres worked with Centecor, and The National Psoriasis Foundation on a public service campaign to raise awareness for psoriasis
  13. Hector Elizondo on a campaign for CaringforAlz; campaign focused on the caregivers of Alzheimers patients (Hector’s mother suffered from the condition).  This was a national campaign supported by the Exelon brand team at Novartis.

According to the post, Rx Entertain manages the negotiation process between the celebs and pharmaceutical/biotechnology from beginning to end. There was no mention of the salaries paid to the celebrities for their participation in the DTC ads.  However the Rx Entertainment founder did offer several bits of cautionary advice:

The celebrity spokesperson ought to have a legitimate tie to the disease and that A-list celebrities may not always be the most appropriate spokespeople because of the baggage (scheduling issues, entourage and additional difficulties) they may bring to the campaign. 

That said who knew that B-list celebs had good shots at potential careers in the pharmaceutical and biotechnology industries? Talk about alternate career paths!

Until next time....

Good Luck and Good Job Hunting (ever consider acting????) !!!!!!!

Conflict of Interest Allegations Swirl around the New NDM-1 "Superbug" Designation

As I noted in a post a couple of days ago, the media frenzy surrounding the identification of a new beta lactamase and erythromycin inactivating enzyme in strains of Klebsiella pneumoniae and Escherichia coli was neither noteworthy nor anything to get all worked up about. For whatever reason, the media reported results of an almost year old research study. If the results of this study had serious public health implications why did it take media outlets so long to report it to the lay public? I suspect that the report was a cleverly crafted promotional campaign underwritten by pharmaceutical companies that are trying to boost sales of their antibiotics. To that end, the Pharmalot Blog reported yesterday about potential conflicts of interests for several of the study’s authors.

According to the Pharmalot post, “The study in The Lancet was funded by the European Union, as well as Wyeth and the Wellcome Trust charity, both of which are involved in producing antibiotics for treating such cases, CNN-IBN reports. Karthikeyan Kumaraswamy, the scientist who headed the study, received a travel grant from Wyeth. And David Livermore, another co-author, received conference support from numerous drugmakers and also holds stock in AstraZeneca, Merck, Pfizer and GlaxoSmithKline, the report continues.”

These revelations caused spokespersons from the Indian government to issue the following statement:

“This news has created a misconception and a feeling that the point of origin of the bacteria is in India. We have got the matter examined. We have come to a conclusion that this is not the right statement. After seeing the research paper, I strongly refute that hospitals in India are the source of the strain and strongly condemn naming the bacteria after New Delhi,” Director General of Health Services RK Srivastav tells CNN-IBN. “Intellectual scientific freedom is all very good but there is a conflict of interest in this research. Researchers like these are examined separately according to the code of ethics.”

Back in the day, it was commonplace to assign the city or country of origin to bacterial isolates. And, I see no reason why this should not continue. While I disagree with the Indian government’s claim that the NDM-1 strain designation will interfere with tourism in that country, I still contend that elevation of the study results to the international stage was premature and largely irresponsible. The fact that several of the study’s co-authors were or are funded by pharmaceutical companies and own stock in these companies suggest that the media frenzy may have been “stoked” for personal and corporate gains.

Hat tip to Ed at Pharmalot!

Until next time...

Good Luck and Good Job Hunting (try clinical microbiology)

 

Lilly Lays Off More Employees and Vows to Remain Lean

Despite assertions by its CEO that there isn’t enough scientific talent in the US, Eli Lilly announced that it will lay off a couple of thousand employees within the next 90 days. Most of the cuts will take place in Indianapolis at four different sites where the company currently employees about 13,000 workers. According to an article in today’s Indianapolis Star

“The struggling Indianapolis company, which has been cutting thousands of jobs in recent months, told the state on Monday that its downsizing is not temporary, but for the long haul.

The reductions in force at the Indianapolis sites of employment are expected to be permanent," wrote Kay Jackson, Lilly's senior director of human resources, in a letter to the Indiana Department of Workforce Development. She added that the cuts, when added up, are not expected to be more than 33 percent of the head count at any one site, or more than 500 workers at any site."

Like most of its rival big pharma companies, Lilly has cut the number of full-time equivalent workers by about 2,100 worldwide since last September. That's when it announced it would cut a total of 5,500 workers worldwide by 2011 to save $1 billion in annual costs. The reason for the cuts; an expected steep falloff in revenues over the next few years when the patents on Lilly's blockbuster drugs begin to expire and face low-priced generic competition  

John C. Lechleiter, Ph.D, Lilly’s CEO, contends that the lack of innovation and new product development at most American pharmaceutical companies can be explained by a dearth of qualified and adequately trained American scientists. Maybe this is why most pharma R&D job are currently being outsourced to China, India, Brazil and Eastern Europe? Alternatively, it may be cheaper to employ US-trained foreign nationals in these places rather than high priced American scientists who perform similar jobs in the US.  

Until next time...

Good Luck and Good Job Hunting (forget Indiana-not there is anything wrong with it)

 

More Trouble at Genzyme

Can things get any worse at Genzyme? First there were the manufacturing problems that result in plummeting stock share prices and a proxy battle by Carl Icahn and company. Next up was a $175 million consent decree judgment levied by the US Food and Drug Administration for the manufacturing problems. Then came the $18 billion takeover bid from Sanofi Aventis. Now, patients affected by shortages of the drugs Fabrazyme three patients have petitioned the US Department of Health and Human Services (HHS) to disregard Genzyme’s patent for the medicine to overcome the drug shortages.

Because of the manufacturing problems, Genzyme rationed its supplies of Fabrazyme to one-third of the normal dose for Fabry disease patients. Some of these patients reported increased pain and no newly diagnosed patients could receive the drug. Meanwhile, Shire Pharmaceuticals has been trying to obtain FDA approval of its Fabry disease treatment, Replagal which is approved in Europe.

The patients who petitioned HHS contend that HHS can override the patents because the National Institutes of Health paid for research at the Mount Sinai School of Medicine, which exclusively licensed Fabrazyme to Genzyme. The goal of the action is to induce another company to produce the drug in case Genzyme is unable to deliver adequate quantities to new and existing patients. Provisions in the Bayh-Dole Act suggest that this action may not be unreasonable if ‘a licensee cannot reasonably meet the public health and safety needs of the American public.’

Stay tuned for the next installment of the continuing Genzyme saga!

 

Merck Inks a Deal with Sinopharm to Bolster Its Vaccine (and Biosimilar ?) Business in China

Merck & Co today announced that is reached an agreement with Sinopharm Group Co Ltd one of China’s largest biopharmaceutical companies to market its cervical cancer vaccine Gardasil and other protein-based products in China. While the terms of the deal were not disclosed, it is Merck’s first attempt to expand its vaccine and biotechnology business in the rapidly emerging Chinese biopharmaceutical market. Merck, like many other American pharmaceutical companies, now recognize that a Chinese marketing and distribution partner is required to successfully penetrate and compete in China.

Like other big pharma companies, Merck recognizes that its future growth lies in making inroads into emerging markets like Asia, Africa and South America.  Merck executives project that more than 25 percent of the companies pharmaceutical and vaccine sales will come from emerging markets by 2013 (currently 17 percent of revenues are derived from emerging markets). Last May, Merck indicated that it already had 3,000 sales representatives in China which represents a 90 percent increase since 2007.

Cancer is a major problem in China and it is putting a lot of financial pressure on the Chinese government. Moreover, the cervical cancer rate is inordinately high in China mainly because there is no formal screening program similar to those found in the US and Europe. 

Interestingly, the Human Papilloma Virus (HPV) types that cause cervical and other cancers in China are somewhat different than those that cause disease in Western countries. For example in addition to HPV 16 and HPV 18, HPV 58, 52 and 33 have also been associated with a high incidence of cervical cancer in China. This suggests that Merck will have to reformulate Gardasil (which contains HPV 6, 11, 16 and 18) to be effective for the Chinese market.

Until next time...

Good Luck and Good Job Hunting!!!!!! (try China)

 

Finally, a Strategic Move that Makes Sense: Sanofi Aventis Makes a Bid for Genzyme

The New York Times reported today that French drug maker Sanofi Aventis has made a bid to purchase beleaguered orphan drug manufacturer Genzyme. According to the report, Sanofi approached Genzyme about two weeks ago about a possible sale. Sanofi is currently waiting for a response from Genzyme. If Genzyme rebuffs the takeover bid, persons close to the deal said that Sanofi may possibly try to acquire Genzyme via a hostile takeover bid.

Sanofi is facing revenue losses because many of its blockbuster products including the anti-clotting agents Plavix and Lovenox will or have lost patent protection. Plavix's patent expiry will occur in 2001 whereas Lovenox has already lost patent protection ( yesterday the FDA approved a generic version of the drug). Further, Sanofi, unlike most major pharmaceutical companies, is glaringly deficient in biotechnology products and has long been known to be seeking a quick entry into the biotech market. To that end, the Genzyme bid makes complete strategic sense to bolster sales and secure Sanofi's future.

Genzyme is the fifth largest biotechnology company in the world. Sales of it orphan drugs to treat Gaucher’s, Fabry and Pompe disease annually exceed $3.0 billion in sales even though they are used to treat small numbers of patients (<20,000).

Genzyme’s value has plummeted in the past year because of manufacturing problems and is currently operating under a US Food and Drug Administration consent decree after being fined $175 million by the agency. Many shareholders have called for the dismissal of Henri Termeer, Genzyme’s CEO for the past 25 years. To date, Termeer has refused to step down even though Genzyme’s stock continues to under perform. News of a possible takeover caused Genzyme’s stock price to soar; gaining more than 15 per cent on Friday to $62.50.

I believe that Sanofi is approaching Genzyme at the right time. Recently, Genzyme reached an agreement with Carl Icahn, who owns a substantially amount of stock, to prevent a proxy battle to reshape Genzyme’s board and oust Termeer. Also, another major shareholder, Ralph Whitworth, is unhappy with recent events at the company. Sanofi’s acquisition of Genzyme would provide a quick entry into the biotechnology and orphan drug markets and also appease shareholders like Icahn and Whitworth if the deal is rich enough. Also, Sanofi’s manufacturing experience would help Genzyme overcome its problems in that area.

Stay tuned for updates.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

 

Correction: High not "Hit" Throughput Screening

Yesterday, I posted a piece on "hit'  throughput screening (see below).  At the time, I learned about  'hit" throughput screening, I mentioned that  I had never heard of "hit" throughput screening but I did know about high throughput screening.  As it turns out, there was a problem in translation and in fact, there is no such thing as hit throughput screening and it is actually high throughput screening.  Mea Culpa!  I apologize for the error and in the future I will be assiduous in my fact checking before I post (a lesson that the boneheads in the Obama administration learned the hard way in the recent Sherrod brouhaha)

The Growth of High Throughput Screening

No; this isn’t a typo! My colleagues at Meet the Boss sent me a press release today about efforts underway at Pfizer and GlaxoSmithKline to redefine HTS to mean “hit” throughput screening rather than high throughput screening. As many of you may know, high throughput screening which began in the mid 1990s was supposed to revolutionize drug discovery and development—it did not! Nevertheless, after almost 15 years of refinement it appears that the technology may be paying off and can be used as an adjunctive tool to expedite and lower the cost of small molecule and protein-based drug discovery. While I don’t know much about this emerging technology, the press release presented below suggests that a meeting about HTS may be in the works. 

It is understood that huge amounts of money have been invested into drug discovery and the biggest problem faced by the industry is investing in drugs which may not make it onto the market. Europe has always been seen to trail behind the US when discussing drug discovery within the pharmaceutical industry, but with the biotechnology revolution they have begun to catch and becoming a driving force within the global industry.

The NGP EU committee has been celebrating the success of their pioneering roles in genome sequencing and the development of proteomic. Pfizer has recently announced to the NGP Drug Discovery committee that they plan to roll out a hit identification and screening file strategy. The process will offer a new flexible strategy for hit identification while sculpting a more reliable and efficient screening process. 

High throughput screening (HTS) has grown rapidly over the last ten years and Pfizer themselves noted the huge advances in both detection technology and laboratory automation. Pfizer believe that not only big Pharma but also smaller companies can implement HTS as well. By implementing HTS,  it can remove the indecision over which compunds will be profiles, many smaller companies agonize over the costs of conventional profiling sometimes only choosing between 10 and 20 compounds, this already removes other possibilities before true research can really begin. Pfizer among other members of the NGP EU Drug Discovery committee wish to discuss how they wish to implement large scale profiling at a lower cost, while maintaining the incredible biological, technological, and scientific advancements they are already demonstrating globally.

GSK have also joined Pfizer recently in encouraging the implementation of HTS. “We are now at a stage where we can exploit the benefits of cutting edge technology for increased quality, performance and capabilities. We also have the option to supply the same number of compounds, with the same level of quality at an affordable price”. 

Key to discussions will be representatives from AstraZeneca - Goran Wennberg, VP Discovery Information, Bayer Schering Pharma - Andreas Busch, Head of Global Drug Discovery & Member of the Board , Novartis - Olivier Grenet , Group Head of Genome Biology ,GlaxoSmithKline - Tino Rossi, VP of PreClinical Drug Discovery & Enabling Technologies and Pfizer - John Mathias, Head of High Through Put Screening all determined to firmly place Europe as the Drug Discovery capital.

The discovery and implementation of HTS not only offers an opportunity to smaller Pharma companies but also the consumer, if research and quality is increased and cost decreased this in turn will be passed onto the consumer.

Stay tuned for more details.

Until next time...

Good Luck and Good Job Hunting

 

The Biotechnology Industry Keeps on Getting Smaller: Celgene Buys Abraxis Biosciences for $2.9 Billion

The recession is clearly taking its toll on the biotechnology industry and continues to force it to consolidate. Today, Celgene announced that it would purchase Los Angeles, CA-based Abraxis Biosciences, Inc for $2.9 billion in cash and stock to expand its cancer drug pipeline. The company hopes to "re-energize" sales of Abraxis' only approved drug, the breast cancer treatment Abraxane, and also win approval for Abraxane as a treatment for skin, lung, and pancreatic cancer.  Sales of Abraxane began to tank after Astra Zeneca terminated a marketing agreement with Abraxis in 2008. Abraxane is an injectable medicine that is approved to treat breast cancer in patients who have failed all other treatment options.

New Jersey-based Celgene, the maker of Revlimid (multiple myeloma, and one type of the bone barrow disease myelodysplastic syndrome) and Vidazas (acute myeloid leukemia and five types of myelodysplastic syndrome) expects to seek approval of Abraxane as a treatment for lung cancer early next year. Celegene also sells Thalomid, a modified version of thalidomide, to treat mutliple myeloma and certain forms of leprosy.

Abraxis Biosciences employs about 900 people. While no layoffs or job cuts were announced, don’t be surprised when they happen shortly after the deal closes later this year.

Until next time...

Good Luck and Good Job Hunting!!!!!!

 

Lilly and Walmart to Sell Co-Branded Insulin?

The once venerable drugmarker Eli Lilly & Co yesterday announced that it would co-brand its Humulin insulin product with Walmart one of the world’s largest retailers starting in mid September. According to a Lilly spokesperson the product will be sold in U.S. Wal-Mart pharmacies.

Humulin, with $1 billion in worldwide sales for Lilly last year, will be Lilly’s first co-branded product with a retail pharmacy and will replace Wal-Mart’s current Relion insulin brand. The Lilly-Walmart deal is indicative of the massive changes that are taking place in the pharmaceutical industry as generic products begin to encroach on blockbuster brand name product franchises. 

The move will undoubtedly expand the product lifecycle of Lilly’s Humulin brand given Walmart’s vast distribution channels and its gargantuan customer base.

Until next time...

Good Luck and Good Job Hunting!!!!!!

 

Post Merger: Are Things Getting Any Better at Pfizer?

Pfizer’s acquisition of Wyeth was supposed to provide the company with expertise—that was sorely lacking—in biologics and biotechnology products. While it is too early to ascertain whether or not the Wyeth acquisition will “bear fruit”, today’s announcement that Pfizer is suspending all clinical trials of tanezumab, a monoclonal antibody treatment for osteoarthritis, suggests that the company may need more help than expected to develop new biological products. According to a statement, Pfizer’s immediate worldwide suspension of the clinical trials followed a small number of reports of tanezumab patients experience worsening of osteoarthritis leading to joint replacement.

Things have not gone well for Pfizer lately. Earlier this year the company abandoned late stage clinical development of an Alzheimer drug called dimebon that it had licensed from a smaller specialty pharmaceutical company. Also in 2010, Pfizer halted clinical development of Sutent for breast and liver cancer after it failed to meet principal goals in two Phase III trials. Finally, several years ago, the company killed late stage clinical development of a highly touted new cholesterol drug torcetrapib (Lipitor’ successor) after it failed to meet clinical endpoints in a pivotal Phase III trial.

Not surprisingly, Wall Street analysts are not particularly enthusiastic about Pfizer’s future. Many consider Pfizer to have one of the worst pipelines among major pharmaceutical companies. Also, many believe that productivity at the company is lacking in almost all therapeutic areas. In defense of the productivity of Pfizer R&D scientists (those who still have jobs), it is extremely difficult to remain productive or focused when major acquisitions e.g. Warner Lambert, Pharmacia and Wyeth occur every few years. As I have stated numerous times before, bigger isn’t always necessarily better. Here’s hoping that the Wyeth acquisition can rescue Pfizer from its current “death spiral” and return some value to its shareholders.

Until next time...

Good Luck and Good Job Hunting!!!!!!

 

Pharma and Philanthropy?

Pharmaceutical and biotechnology companies like to distinguish themselves from companies that manufacture consumer products because their products have the potential to save the lives of patients suffering from a plethora of illnesses. While a life-saving cancer treatment may inherently be more valuable than a pair of snow tires, the goal of the companies that manufacture them is to sell enough products to remain profitable. To that end, pharmaceutical and biotechnology companies have an edge over consumer products companies because drug makers can use altruism and philanthropy to market their drugs. In fact, many drug manufacturers play up their commitments to altruism and philanthropy to justify high drug prices because of the enormous costs associated with drug discovery and development. This tactic begs the question: “Just how philanthropic are drug makers?”

To answer this question The Access to Medicine Foundation created the Access to Medicine Index .which provides a benchmark on the access to medicine policies and practices of the largest global pharmaceutical companies.The index is designed to offer stakeholder and prospective investor ways to compare pharma’s social responsibility records by measuring 106 indicators that examine activities across seven criteria such as philanthropy, patents, pricing and management (see more here)

The 2010 index (only the second of its kind) ranked 26 pharmaceutical companies on their efforts to provide access to medicines, vaccines and diagnostic tests to people living in 88 countries. The companies included 20 originator (branded) companies – those who primarily market patented drugs they have developed – andsix companies whose primary business is the production and sale of generic medicines. The results are shown below:

Branded Pharmaceutical Companies

  1. GlaxoSmithKline
  2. Merck
  3. Novartis
  4. Gilead Sciences
  5. Sanofi-Aventis
  6. Roche
  7. AstraZeneca
  8. Novo Nordisk
  9. Johnson & Johnson
  10. Abbott Labs
  11. Pfizer
  12. Boehringer Ingelheim
  13. Eli Lilly
  14. Bayer
  15. Bristol-Myers Squibb
  16. Eisai
  17. Merck KGA
  18. Takeda Pharmaceuticals
  19. Astellas Pharma
  20. Daiichi Sankyo

Generic Manufacturers

  1. Ranbaxy Laboratories Limited
  2. Cipla Limited
  3. Dr. Reddy’s Laboratories
  4. Mylan, Inc
  5. Sun Pharmaceuticals
  6. Teva Pharmaceuticals Ltd.

While the lists may seem impressive, Index founder Wim Leereveld cautions: “…the industry as a whole still has a long way to go.”

Ed Silverman, who runs the Pharmalot Blog, offered his insights about the list and the foundation’s findings: “The report, of course, will be used to defuse critics, such as non-governmental organizations and activist groups, who say not enough is done to make meds accessible in poor countries. The arguments often center on compulsory licensing and free-trade agreements, as well as intellectual property disputes, pricing and donations. Pharma, you may recall, has been on the defensive ever since they fought South Africa over HIV meds, and is now ramping up operations in so-called emerging markets, many of which are low-margin operations where incomes are lower. “

I don’t fault drug makers for aggressively marketing their products to generate revenues to insure profits and growth. After all, business is business. However, I think that it is disingenuous to use altruism and philanthropy as a means to market and sell high priced drugs. Ironically, this practice tends to limit the access of poor and disenfranchised patients who might benefit the most from these medicines.

Hat tip to Ed at Pharmalot

Until next time...

Good Luck and Good Job Hunting!!!!!!!

 

Another Setback for Merck

Earlier this month, Merck BioVentures, the company’s new division focused on developing follow-on biologics aka biosimilars announced that it was scuttling plans to develop MK-2578, a PEGylated version of erythropoietin (EPO); its first follow-on biologics candidate (someone should have mentioned to Merck that PEG-EPO is NOT a follow-on product but actually a NME that would require full regulatory approval).  In yet another setback, this past week the US Food and Drug Administration (FDA) postponed a decision to broaden usage of its Gardasil human papillomavirus (HPV) vaccine to women between the ages of 27 and 45.

The company had submitted new data to agency and had hoped to hear by the end of June about the new indication for Gardasil; FDA will likely delay a response until the end of 2010. Gardasil is already approved to protect against some strains of the human papillomavirus, which can lead to cervical cancer, in girls and women ages 9 to 26. It is also approved to prevent genital warts in males of the same age. Merck has aggressively been trying to expand the indications for the vaccine to bolster sales. Gardasil revenue in 2009 was $1.1 billion, down from $1.4 billion in 2008 and $1.48 billion in 2007.

Decreasing sales have been attributed to high cost of the vaccine and concerns over side effects after vaccination. Also, some parents’ worry that Gardasil vaccination may suggest to teenagers that premarital sex is okay. Interestingly, while cervical cancer remains a risk among HPV-infected girls and women, a recent study found that only 34 percent of teenage girls ages 13 to 17 received Merck’s Gardasil human papillomavirus vaccine. Finally, sales of Cervarix, a competing HPV vaccine developed by GlaxoSmithKline, are beginning to cut into Gardasil market share.

Until next time...

Good Luck and Good Job Hunting!!!

 

YouTube and Pharma: An Update

There is no question that video is taking the Internet by storm and is quickly replacing the written word as a means of communication. Despite the obvious business opportunities offered by videos, most big pharma companies have failed to jump on the video bandwagon. As always, there are exceptions to the status quo and a handful of life sciences companies most notably Johnson & Johnson, have been experimenting with video over the past few years.

According to Mark Senak, the unofficial life sciences company video archivist and author of the always insightful EyeonFDA blog, there are presently about 15 companies that have channels on YouTube; the largest video sharing website on the Internet. Previously, Mark was able to find 10 or so active companies on the YouTube website. Despite this modest increase, Mark notes that most pharma YouTube channels are not regularly maintained and suffer from lack of original content. 

There is no question that video is expensive to make if it is done commercially. However, Ken Grant at Analtech, a small chromatography company in Delaware, who has successfully used video to drive and improve business outcomes, contends that a low cost Flip video camera or equivalent is sufficient to get the job done! 

I suspect that big pharma may be waiting for FDA to weigh in on the use of social media for promotional purposes before it allocates any resources for video production. However, as I have stated many times before, social media can be used in many other ways (besides for promotional purposes) to meet business objectives and maintain corporate brand integrity. Until pharma marketers and brand managers recognize this, social media and pharma will be a moot point.

Until next time...

Good Luck and Good Job Hunting!!!!!!!

 

New Directions: Pfizer Creates an Orphan Drug Division

Pfizer today announced plans to set up a Rare Diseases Research Unit that will target the more-than-6000 global orphan diseases. For those of you who may not know, orphan diseases are classified by the US Food and Drug Administration as those that afflict 200,000 persons or less.

According to a press release, Pfizer’s new division will “pursue treatments across all therapeutic areas and modalities and will serve as the focal point for the company’s existing research on rare diseases”. It also intends to “work closely with patient advocacy groups, like the National Organization for Rare Diseases, as it develops and advances the unit’s research strategy. It will be lead by Edward Mascioli, most recently the head of Dapis Capital, a private equity firm. Previously he was vice president of clinical affairs at Peptimmune and senior medical director at Paraxel.

Pfizer’s decision to enter the orphan drug market signals that no markets are too small for big pharmaceutical companies to consider in an era where blockbuster drugs are few and far between. Nevertheless, it is noteworthy that orphan drugs (which are generally biologics) offer drug maker several perks including: seven years of market exclusivity, tax breaks and credits, reduced clinical trials costs and expedited regulatory review. More importantly, perhaps, orphan drugs are highly priced and can yield impressive returns even though they are used to treat small patient populations. For example, several of Genzyme’s drugs such as Myozyme and Cerezyme—both designated as orphan drugs—have already reached over $1.0 billion in annual sales. 

While sales of orphan drugs may never reach those of Plavix, Lipitor, Epogen and other multibillion dollar blockbusters, garnering US regulatory approval for four or more (which cost much less than $1.5 billion to develop) will likely provide a substantial ROI to companies that develop them. Also, developing drugs that improve the quality of life for patients with no other treatment options will undoubtedly go a long way to improve tarnished reputation of the pharmaceutical industry.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

 

Situation Not Improving at Johnson & Johnson's McNeil Consumer Healthcare Unit

Johnson & Johnson’s McNeil Consumer Healthcare, already under Congressional investigation for selling allegedly tainted Tylenol, announced late Tuesday that it was recalling other products made in the Puerto Rico manufacturing facility in question.

According to an article in today’s New York Times, “McNeil Consumer Healthcare, the Johnson & Johnson unit, said that it was recalling four lots of certain Benadryl allergy tablets and one lot of Extra Strength Tylenol gel pills. McNeil did not respond to a reporter’s query about how many bottles those lots amounted to.”

Since last November, McNeil has recalled about 11.7 million bottles of various Motrin products and about 6.3 million bottles of Tylenol Arthritis Pain caplets made at the Puerto Rico plant in question. The company began the product recall after receiving numerous consumer complaints about a moldy odor emanating from some of its products.

Company representatives contend that the moldy smell was caused by contamination from a chemical byproduct of a substance used to treat wooden transport pallets. Further, McNeil suggested that the risk of serious medical problems was remote and people should not stop using the products (yeah right).

The current recall just adds to McNeil’s growing manufacturing problems. The company is already under scrutiny by the House Committee on Oversight and Government Reform over a recall last April of an estimated 136 million bottles of liquid pediatric Tylenol, Motrin, Benadryl and Zyrtec.

I suspect that more problems will be uncovered as the FDA and Congressional investigations continue. Serious manufacturing and quality problems can almost always be avoided or minimized when company executives and management makes a bona fide commitment to quality systems. Clearly, the heads of McNeil Consumer Healthcare might benefit from remedial current good manufacturing practices (cGMP) training.

Until next time...

Good Luck and Good Job Hunting!!!!!!!

 

Finally Some Good News for Genzyme

After weeks of bad press regarding manufacturing problems and a narrowly-averted proxy contest, Genzyme today announced that its experimental drug for multiple sclerosis, alemtuzumab, received fast track approval status from the US Food and Drug Administration (FDA).

Alemtuzumab (marketed as Campath, MabCampath or Campath-1H) is a monoclonal antibody used in the treatment of chronic lymphocytic leukemia (CLL), cutaneous T-cell lymphoma (CTCL) and T-cell lymphoma. Alemtuzumab targets CD52, a protein present on the surface of mature lymphocytes, but not on the stem cells from which these lymphocytes are derived.

For those of you who may not know, FDA grants fast track status to experimental drug candidates that are designed to treat serious diseases, and may be superior to current treatments. Fast track status includes an expedited review and additional collaboration between Genzyme and the and the agency and allows Genzyme to submit portions of the alemtuzumab BLA as they are completed, rather than waiting to submit the completed application when testing is finished.

Until next time..

Good Luck and Good Job Hunting!!!

 

FDA Begins Reining In Genetic Testing Companies: It's About Time!

The US Food and Drug Administration (FDA) announced on Friday that it will begin monitoring and investigating the services offered by consumer-focused, personal genomic testing companies. In warning letters to five companies, the agency notified company executives that their tests are considered medical devices and therefore must be federally approved as safe and effective. None of the companies have submitted their products for approval, according to the FDA. Further, the agency contends that personal genomic tests as medical devices must be “analytically and clinically accurate so that individuals are not misled by incorrect test results or unsupported clinical interpretations." Previously, the agency hadn’t definitively classified the tests as medical devices. However, the agency has become increasingly concerned that results from the tests may ultimately be used for diagnostics and prognostic purposes by various entities including insurance companies and employers.

The companies that received letters on Friday included California-based 23 and Me (backed by Google Health), Navigenics and Illumina and Knome of Cambridge, Mass.; and deCode Genetics of Lake Barrington, Ill. The FDA sent a similar letter in May to Pathway Genomics of San Diego, after Pathway announced it intended to sell its tests through Walgreens drugstores. Many industry insiders believe that the proposed Pathway Genomic-Walgreens was the proverbial “straw that broke the camel’s back” which prematurely forced the agency to take regulatory action.

The letters deal with specific tests marketed by: 23andMe Inc., deCODE Genetics, Illumina, Navigenics and Knome Inc. FDA asks each of the companies to contact the agency to make arrangements for submitting their tests for review. 23andMe and Navigenics and DeCode Genetics, sell tests that scan a person’s DNA, looking at genetic variations that can suggest whether a person is at a higher or lower risk of getting certain diseases like cancer or diabetes. Illumina sells DNA chips that are used by some companies to do the DNA scans whereas Knome offers consumers a complete sequence of their DNA, which can be used to glean disease risk information. While 23 and Me is pushing back, deCode Genetics CEO stated that the company will work with the agency to legitimize its tests as part of “standard medical care.” Knome, whose whole genomic sequencing platform will ultimately supplant the services offered by 23 and Me, Navigenics and Pathway Genomics, has also expressed a willingness to work with the agency.

Despite the existence of theGenetic Information Nondiscrimination Act (GINA) enacted in May 2008—which ostensibly would shield patients from potential “genetic discrimination”—many privacy and medical information advocates fear that loopholes will allow insurance companies and prospective employers to abuse the results from personal genomic analyses. To that end, GINA does not cover life, individual disability insurance, or long-term care insurance, and the potential for genetic discrimination still exists in these areas. For example, a person at genetic risk for developing Alzheimer’s could be denied long-term healthcare insurance because Alzheimer’s patients have been known to live for long periods of time, and their care is costly.

Another legitimate concern raised by some people is ownership of the results of personal genomic analyses. Surprisingly, at present, it isn’t clear who owns or ultimately controls a person’s genetic information data after it is generated. For example, it is likely (but not certain) that a consumer who purchases whole genome sequencing services from a personal genomics company owns and controls his/her sequence data. Ownership and control of the information isn’t likely to be straightforward or easily defined until rules and regulations are crafted to clarify how genomic information is owned, stored, and accessed by individuals and third parties.

While companies like 23 and Me and their ilk aren’t pleased that FDA has finally classified their tests as medical devices, they had to know that regulatory oversight of the personal genomic testing business was inevitable. This is because the results from personal genomic tests have been and will continue to be used by various and sundry entities a diagnostic and prognostic tools.

It is obvious to almost everyone in the life sciences industry that there are huge sums of money to be made in the personal genomic testing space. Consequently, the last thing that personal genomics company executives wanted was regulatory oversight by FDA (it tends to interfere with business and profit margins). However, we all have experienced first hand what happens when companies are allowed to operate in the absence regulatory oversight.

Hat tip to FDA for finally taking a stand on this important issue!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

 

Lilly CEO: "US is Losing it Edge in Life Sciences Innovation"

John Lechleiter, PhD, chairman and CEO of Eli Lilly & Co. today told members of the Detroit Economic Club that the US is losing its competitive edge and that “evidence is mounting for an innovation crisis in the life sciences

Lechleiter blamed the crisis on US tax and immigration policies over the last 10 years that have reduced research and investment funding and driven away foreign-born, U.S.-trained scientists.

He also attributed the problem to the US Food and Drug Administration’s new emphasis on drug safety.  “The FDA approved 92 drugs the last five years. That is the lowest of any five-year period,” he said. “We lose patent protections (on brand name drugs) and that is $100 billion less revenue for the industry and less for research and development” said Lechleiter. Further, he said that “American drug companies still spend 40 percent more on research in development in the U.S. than in other parts of the world.”

To avert the crisis, Lechleiter suggested the following: 

  1. Increase and improve education for students in math and science
  2. Change immigration laws to allow more H1-B visas for scientists and ease the process that allows immigrants to gain green cards to work in the U.S. The last time the H1-B visa cap was raised was in 1990
  3. Increase federal funding for pharmaceutical and basic science research, which has declined over the last five years
  4. Change tax policies to provide more incentives for research and development. The U.S. lags behind the rest of the world in offering R&D tax credits, he said. Moreover, the U.S. should not tax foreign subsidiaries of U.S. corporations

Lechleiter, who was trained as a chemist, is the only CEO of a major pharmaceutical company who holds a PhD degree. Therefore, his ideas resonate more for me than those of his business-only CEO counterparts. To that end, his suggestions regarding improving math and science education, immigration reform (which I have long contended is killing US competitiveness) and increasing federal funding for research make sense. However, the notion that US tax laws and lack of corporate tax incentives is stifling American innovation and competitiveness is pure hogwash.

While corporate tax rates may be higher in the US than elsewhere, there are so many loop holes that most corporations pay less than their share fair. Further, let’s not forget that the personal income tax rate is much higher in the rest of the developed world than it is in the US. It is just so “American” to not want to pay taxes and then demand and expect government services at no cost to the taxpayer (at least in Europe they pay high taxes and get good services).  And, let's not forget that despite their heavy tax burden it was American corporations not foreign ones that caused the recent global recession.

That said, I gotta give John some credit for his suggestions; three out of four (or a .750 average) isn’t bad in baseball or the pharmaceutical industry!

Hat tip to Ed at Pharmalot

Until next time...

Good Luck and Good Job Hunting!!!!!!

 

Why Layoffs Won't Help Big Pharma

For the past three years, I assiduously have attempted to track all of the major layoffs announced by big pharma and biotechnology companies. Quite honestly, it has been hard to stay on top of these almost weekly announcements. To date, over 200,000 life sciences employees have lost their jobs. And, I don’t think that job layoffs will abate for a year or more.

While pharma layoffs make sense in the short term—most notably to insure that stock share prices remain as inflated as possible—they are not going to solve pharma’s lack of innovation and the rising attrition rates for new molecular entities. On paper, outsourcing R&D make perfect fiscal and scientific sense. After all, there are literal thousands of US-trained scientists all over the world these days; mainly in China, India and Eastern Europe and it is much more cost effective to do research in these regions. However, in my opinion, outsourcing R&D, like layoffs, is a short term strategy that will likely backfire and not deliver the anticipated ROI. For example, many US technology companies that outsourced sizable portions of their operations in the early 2000 are now beginning to bring them back to the US as Asian labor costs continue to rise and product quality declines. This begs the question: what should big pharma companies do to regain their edge to bring new medicines to market?

Allan Haberman, of Haberman Associates, wrote a compelling post several months ago on his blog the Biopharmconsortium Blog where he offers some insights and strategies that may help big pharma out of its current lack of innovation and new product development.  Until that happens, I will continue to track pharma and biotech company layoffs as they are announced.

Until next time....

Good Luck and Good Job Hunting!!!!!!!!

 

Pfizer Employees Evicted From Office Space in Connecticut

The fallout from Pfizer’s purchase of Wyeth last year continues to slog on. Today, Pfizer told 500 scientists who reside in one of three of the company’s office towers in New London, CT that they will be relocated within the next month.

An e-mail message sent to the 500 affected scientists explained that “a business entity with an immediate need for office space has expressed interest in the New London property.” While a Pfizer spokesperson refused the identify the prospective new renter, sources familiar with the situation believe that Electric Boat in Groton, a division of General Dynamics,  which previously expressed a need for 50,000 square feet to house a growing engineering department is the likely new client.

The move shouldn’t come as a surprise to the New London scientists because Pfizer announced last year that it would close the 700,000 square-foot former worldwide R&D headquarters by the end of 2011. Most of the company’s 1,400 drug-development employees in New London will move across the Thames River to the company’s research site in Groton. Nevertheless, the indignity of being evicted and forced to relocate by a bunch of engineers must really smart—not that there is anything wrong with engineers!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

 

What's Up With Follow-on Biologics aka Biosimilars?

The conversation about follow-on biologics became extremely muted after passage of the US Healthcare Reform Act which included a 12 year period of data exclusivity for innovator company products. This provision inhibits biosimilar manufacturers from introducing generic versions of branded biologics for 12 years from the date the US Food and Drug Administration granted a license for the branded product. While this may effectively limit activity in the follow-on biologics space in the US, it didn’t stop Merck from launching its BioVentures Division (dedicated to follow-on biologics development) almost two years ago.

At the time of the announcement Merck executives in charge of the BioVentures Division divulged that its first product would be a PEGylated version of Amgen’s anemia drug Epogen (EPO). Unfortunately, a PEGylated version of EPO doesn’t qualify as a follow-on biologics because PEGylated proteins are considered new molecular entities (NMEs) by regulatory agencies. Nevertheless, Merck also said it would develop other follow-on products and that its efforts would be based primarily on the proprietary humanized yeast biomanufacturing platform it acquired after purchasing Glycofi, a New Hampshire-based biopharmaceutical company that developed the technology. Interestingly, two weeks ago Merck announced that it was abandoning the PEGylated-EPO product that it mentioned two years ago at the BioVentures kick off press conference.

It isn’t clear whether or not Merck jettisoned the project because of patent infringement litigation, regulatory concerns or possibly because of the increasingly fierce competition in the EPO space. Another possibility is that pharmaceutical companies have finally realized that biologically-active proteins are costly to manufacture and have limited therapeutic applicability as compared with monoclonal antibodies (MAbs) which are taking the biopharmaceutical industry by storm. At last count, there were over 300 MAbs in various phases of pre-clinical development with and about 125 in late stage clinical development. Last week, Teva and Lonza announced plans to develop a biosimilar version of Roche’s anti-inflammatory and cancer MAb Rituxan (rituximab)—kicking off a new era in the biosimilar industry.

For those of you who are unfamiliar with or remain interested in the follow-on biologics debate, I came across a nice PowerPoint presentation given by Teruhide Yamaguchi at the Division of Biological Chemistry and Biologicals at the National Institutes of Health.


Quality Safety and Efficacy of Follow-on Biologics

Until next time...

Good Luck and Good Job Hunting!!!!!!

 

Teva to Commercialize a Biosimilar Monoclonal Antibody: Let the Games Begin!!

It was only a matter of time before some company decided to attempt to commercialize a generic version of a therapeutic monoclonal antibody (MAb). The main barrier to entry to the biosimilar MAb market was the patent expiry dates for the first generation of therapeutic MAbs (most were commercialized in the early 1990s and have patent protection until 2018 or longer). The recent health-care overhaul law signed by President Barack Obama earlier this year permits U.S. regulators to approve biosimilar versions of branded biologic drugs and paves the way for commercialization of biosimilar MAbs (and other biologics) in the US.

This past Monday Teva Pharmaceuticals, the world’s largest generic prescription drug manufacturer, announced its plans to commercialize a generic version of Rituxan (rituximab), Roche’s blockbuster MAb used to treat rheumatoid arthritis, leukemia and certain forms of non-Hodgkin lymphoma. Rituxan has patent protection in the U.S. until 2018 and in the rest of the world through 2013. According to the announcement, Teva joined worked with the biomanufacturing giant Lonza to produce sufficient quantities of generic Rituxan for clinical development.

Earlier this month Teva began recruiting patients with rheumatoid arthritis for a clinical trial comparing its biosimilar copy, TL011, with the Roche drug, sold outside the U.S. as MabThera. Teva and Lonza are focusing on monoclonal antibodies, and aim to gain regulatory approval for their first product by the end of 2014 said a Lonza spokesman.

Rituxan generated $5.24 billion in sales last year. Indian generic-drug maker Dr. Reddy’s Laboratories Ltd. began selling a new version of Rituxan in India in 2007 which had $4.2 million in sales in 2009. Interestingly, the size of the biosimilar MAb market is predicted to be much larger than that for therapeutic proteins like Epogen, Neupogen, Avonex and other therapeutically-active proteins.

What will be the next branded MAb-based product to succumb to the biosimilar encroachment? Only time will tell.....

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!!

 

Big Pharma is Betting on Emerging Markets to Lift Profits

It is no secret that growth of the pharmaceutical industry has slowed to single digits in the past five years or more. In fact, many experts don’t expect there to be double digit growth in this sector for a long time. Instead, future robust growth of the pharmaceutical industry is expected to take place in emerging markets including India, China, Brazil, South Africa and others. This is because the economies of these countries are booming and the middle class in these nations continues to rapidly grow. 

While branded prescriptions drugs once dominated Western markets, it is likely that generics or branded generic products will be the major players in emerging markets. Because of this, big pharma companies such as GlaxoSmithKline, Daiichi Sankyo and most recently Abbott Laboratories have either purchased or crafted large marketing deals with smaller regional drug manufacturers.

Daiichi Sankyo paid $4.0 billion in 2008 for a major share of India’s Ranbaxy Laboratories and GlaxoSmithKline earlier this year acquired exclusive rights to over 100 products produced by Dr. Reddy’s Laboratories, another Indian drug maker with a broad reach in emerging markets.

Today, Abbott Laboratories announced that it would purchase the healthcare business of Piramal Healthcare Ltd, one of India’s largest purveyors of branded generics for $3.72 billion. When the deal closes, Abbott will inherit the rights to about 350 brands and trademarks and a manufacturing plant in northern India. Also, Piramal agreed to a six year non-compete agreement for branded generics. The remaining parts of Piramal include a custom manufacturing business, over-the-counter products, vitamins, diagnostic devices and Piramal Life Sciences a drug discovery company.

The company, which has India’s largest sales force, would become a subsidiary of Abbott Laboratories and employ about 7,500 workers. Last week, Abbott said it would license at least 24 products from Zydus Cadila to sell in emerging markets. Analysts estimate that emerging markets account for 20 percent of Abbott’s business. The Piramal and Zydus Cadila deals suggest that Abbott maybe the company to reckon with in emerging markets in India and elsewhere.

 Until next time...

Good Luck and Good Job Hunting!!!!!!!!

 

More Biotechnology Industry Consolidation: Astellas Pharmaceuticals to Acquire OSI Pharmaceuticals

Melville, NY-based OSI Pharmaceuticals, the maker of the cancer drug Tarceva and arguably one of the most successful biotechnology companies in the New York metropolitan area, has finally agreed to be purchased by Japan’s Astellas Pharma.

Earlier this year, Astellas announced a hostile takeover bid for OSI. After a two month long battle, the OSI board agreed to sell the company to Astellas for $4.0 billion. According to the terms of the deal, OSI shareholders will receive $57.50 per share; a 55 per cent premium to the company’s share price in February. The price represents a 10.5 percent increase over Astellas’ original proposal of $52 per share.

Tarceva is OSI’s only product but sales last year reached about $1.2 billion. The drug has been approved to treat various cancers including non-small cell lung cancer (second line treatment) and first-line advanced pancreatic cancer. OSI has been trying to garner approval for Tarceva to treat other types of cancer in recent years. While sales of Tarceva have been growing annually, OSI’s new drug pipeline has been relatively thin.

OSI was founded in 1983 and is one of the oldest biotechnology companies in New York State. The company currently employs about 524 people. It is not clear what effect, if any, the acquisition may have on those jobs.

Astellas Pharma is Japan’s largest pharmaceutical company which has been on something of a buying spree to enhance its oncology portfolio and expand its US presence. Last year, Astellas lost a battle to acquire CV Therapeutics which was ultimately purchased by California-based Gilead Sciences for $1.4 billion.

Over the past few years Japanese pharmaceutical companies, flush with cash, have been aggressively pursuing American biotechnology companies with oncology expertise. Two years ago, Takeda Pharmaceuticals purchased Boston-based Millennium Pharmaceuticals for $8.8 billion to gain access to Velcade, its multiple myeloma drug and oncology drug pipeline.

The recent Japanese biotechnology buying spree is reminiscent of the Japanese real estate grab in the late 1980s which resulted in the sale of some of America’s iconic buildings including Rockefeller Center and the Empire State Building. Ironically, those buildings are again owned by American companies and private equity groups! 

Until next time…

Good Luck and Good Job Hunting!!!

 

The Pharmaceutical Industry's New Math

Those of us a certain age have all heard of the so-called new math—which by all accounts wasn’t much different than old math—that was suppose to revolutionize the way math was taught at the primary and secondary education levels. While new math may not have not have much different or better than old math from an academic perspective, pharmaceutical companies will have to reckon with the new math associated with the pricing of brand name prescription drugs if they want to remain competitive in the future.

According to statistics offered in a recent New York Times article on Teva Pharmaceuticals, the world’s largest generic drug manufacturer, generics now account for 75 per cent of the prescriptions filled in the United States. This figure is up 47 percent from a decade ago. Further, a recent study from IMS, the research firm that tracks prescription drug use, generic drugs saved the American healthcare system $734 billion between 1999 and 2008. These numbers, coupled with a paltry 25 per cent market share, suggest that brand name pharmaceutical companies must rethink the low volume, large margin pricing strategy that has guided big pharma for the past 50 years. 

As one Teva executive candidly put it, “If you are used to the fat margins of big pharma, it is hard to compete in the rough and tumble of price-cutting generics.” 

The push for wider adoption and use of generic pharmaceuticals and biologics (as compared with brand name drugs) suggests that there will likely be more belt-tightening at big pharma companies in the not-so-distant future.

Until next time..

Good Luck and Good Job Hunting!!!!!!

 

Genzyme Pushes Back

Beleaguered orphan drug manufacturer Genzyme responded to Carl Icahn’s attempt to remove current board members through a proxy fight by issuing a statement announcing a $2.0 billion stock buyback program. Also, the company announced that it would sell or spin off its underperforming genetic testing, diagnostics and pharmaceutical ingredient manufacturing divisions. Both initiatives were announced in an attempt to fend off Icahn’s current assault on the company.

Genzyme spokespersons stated that the company will repurchase $1.0 billion worth of stock in the near term and finance it with debt. An addition $1.0 billion of stock will be purchased over the next year, Genzyme said. While financial analyst believe that the announcement will please shareholders, it is unlikely to ward off the Icahn plan to wrest control of the company away from embattled CEO Henri Termeer.

Until next time..

Good Luck and Good Job Hunting!!!!!!

 

Icahn Turns Up the Heat at Genzyme

Carl Icahn, who controls about 4.9% of the outstanding shares of Genzyme’s stock, is trying to get himself and three persons loyal to him elected to the Genzyme board of directors via a proxy fight

Icahn has publicly stated that embattled Genzyme CEO, Henri Termeer must go after running the company for the past 25 years. Icahn contends that Termeer has made many bad decisions during his tenure and the recent highly publicized manufacturing problems at the company are causing Genzyme’s stock to plummet.

Icahn’s slate of proposed board members include himself, Dr. Richard C. Mulligan, a molecular biologist at Harvard Medical School, Dr. Alexander J. Denner an Icahn confidant and Dr. Stephen J. Burakoff, Director of the Tish Cancer Center at Mount Sinai School of Medicine in New York. If elected the Icahn slate will replace Mr. Termeer, are Connie Mack III, a former United States senator; Richard F. Syron, the former chief executive of Freddie Mac and of Thermo Electron, a scientific instrument company; and Charles L. Cooney, a professor of chemical and biochemical engineering at the Massachusetts Institute of Technology.

As many of you may know, Icahn, who is always referred to as an “activist investor” is no stranger to proxy fights or controversy. Previously, he attempted to oust members of the Biogen-IDEC board of directors—an underperforming company according to Icahn—and more recently, publicly out-maneuvered and humiliated Bristol-Myers Squibb (BMS) CEO Jim Cornelius by selling ImClone—a long-time BMS co-marketing partner of the blockbuster colorectal cancer drug Erbitux— to Eli Lilly.

Over the years, I have been a staunch critic of Icahn. However, I am beginning to realize that there is a “method to his madness” and surprisingly, things always seem to change for the better at companies that are on his radar screen. Like him or not, Icahn demands performance from the companies that he invests in and will relentlessly work on behalf of himself and other shareholders to get the ROI that he expects.

Until next time,

Good Luck and Good Job Hunting!!!!!!!

 

Bristol-Myers Squibb Board Okays $3.0 Billion Stock Repurchase Program; Is BMS Preparing Itself for Sale?

Bristol-Myers Squibb (BMS) announced Tuesday that its board authorized the repurchase of up to $3 billion of its common stock.

The company said the buyback program has no expiration date and will take place over the next few years. Company spokespersons said the decision reflects Bristol-Myers' strong financial position, which included $9.8 billion in cash and marketable securities at the end of the first quarter.

While stock repurchase programs are common, BMS is steeling itself for the expected loss of substantial revenues beginning in 2011 due to patent expiry of its top selling anti-clotting medication Plavix. In the past year or so, the company has sold off a profitable medical device subsidiary (Convatec) and a consumer products company (Meade Johnson) to sure up its finances and improve stock share price. 

Long be rumored to be a takeover target, BMS has attempted to reinvent itself over the past few years as a “next generation biopharmaceutical company” through licensing agreements and acquisition of smaller biotechnology companies with promising technology platforms and near term new biotechnology products (Medarex). However, the loss of Imclone—the biotechnology company that developed the one of the top-selling colon cancer drugs called Erbitux—to rival drug maker Eli Lilly has significantly slowed the next generation initiative.

Stay tuned for all late-breaking events.

Until next time…

Good Luck and Good Job Hunting!!!!!!

 

Genzyme Expected to Be Fined Almost $200 Million for Manufacturing Problems

Genzyme announced yesterday that it expects to be fined roughly $175 million in fines and penalties related to the manufacturing troubles at its Allston Landing, MA manufacturing plant that resulted in severe shortages of two of its best selling products, Cerezyme (Gaucher disease) and Fabrazyme (Fabry disease) 

The fines and penalties are part of a consent decree that the US Food and Drug Administration (FDA) intends to levy against the company for the manufacturing infractions. A substantial portion of the penalties included a disgorgement settlement, a process that allows FDA to collect a certain percentage of the sales of products made at the troubled Genzyme production facility.

According to an article in today’s New York Times business section, Genzyme representatives said that patients using Cerezyme would continue getting half a dose for two or three more months. It previously said full supplies would be restored May.

Patients who use Fabrazyme would continue to be allocated a third of their usual dose at least through the third quarter. The company had previously hoped to resolve the Fabrazyme shortage in the third quarter.

The highly publicized manufacturing problems at Genzyme, has shaken both physician and patient confidence in the company’s ability to safely manufacture and supply sufficient quantities of Cerezyme and Fabrazyme; two orphan drugs designed to treat patients with debilitating genetically-inherited diseases. 

Several physicians and patients who were previously loyal and ardent supporters of Genzyme, have indicated that they may switch to recently approved and new treatments being developed by Genzyme’s competitors that include Shire.

The lack of commitment to quality manufacturing by Genzyme executives has seriously tarnished the image of a once highly respected and reputable orphan drug developer.

Until next time…

Good Luck and Good Job Hunting!!!!!

Until next time…

Good Luck and Good Job Hunting!!!!!!!   

 

One Biopharmaceutical Company's Loss is Another's Gain

The recent manufacturing woes of orphan drug manufacturer Genzyme have been well documented and widely publicized. These problems resulted in massive shortages of some of its top selling drugs Cerezyme (Gaucher disease) and Fabrazyme (Fabry disease) causing many of the patients who depend on these drugs to maintain their quality of life to go without reduced or no treatments for months. 

Because both drugs were approved by the US Food and Drug Administration (FDA) as orphan drugs they enjoy seven years of market exclusivity from the date of regulatory approval which prohibits other companies from seeking approval and selling similar drugs in the US. Consequently, Genzyme is the only commercially-available source for the drugs. Genzyme’s ongoing biomanufacturing created massive shortages of both drugs last summer. Because of this, FDA allowed two other companies, Shire and Protolix Biotherapeutics (both have treatments for Gaucher (Protalix) and Fabry (Shire) disease in late stage clinical development), to make their drugs available (at no charge) to patients prior to regulatory approval. This was a relatively rare and bold move by the agency. But, to be fair, they had little choice because so many patients were suffering.  

In case you may be wondering there are approximately 1500 Cerezyme users and fewer than 1000 Fabrazyme users in the US. Despite the small numbers of patients, the cost of the treatments are extraordinarily high; costing patients as much as $200,000 per year for treatment.

According to an article in today’s NY Times as many a 15 percent of American Cerezyme users have switched to a different drug. Fewer patients with Fabry disease have switched mostly because Shire’s drug for Fabry disease Replagal was less widely available. The almost year-long shortages of both drugs have seriously tarnished Genzyme’s reputation. And previously loyal patients are questioning their almost decade long allegiance to the company. This, coupled with a 26 per cent decline in Genzyme’s stock price last year suggest that Genzyme’s standing as one of the top five biotechnology companies in the world may be in serious jeopardy. 

Despite calls for his resignation (and an attempt by Carl Icahn to wrest control of the company), CEO Henri A. Termeer, who has led Genzyme for over 20 years has vowed not to resign. While manufacturing problems are not uncommon in the biotechnology industry, the severity and ongoing nature of the manufacturing problems at Genzyme’s Allston Landing, MA production facility are unacceptable; especially for a company that specializes and prides itself in developing treatment for orphan disease indications. The FDA recently announced that it would fine Genzyme and place its manufacturing operations under a consent degree for an indefinite period of time.

Genzyme representatives now contend full supplies of Cerezyme will be available after May 1 and those for Fabrazyme possible in the third quarter of this year.

While so-called “copycat” or “me too” drugs developed by pharmaceutical companies tend to be vilified by consumers and patient advocacy groups, the agency prefers to approve more than one treatment option for a given disease indication in case one medication doesn’t deliver the intended therapeutic benefits or induces untoward adverse events. Unfortunately, the seven years of market exclusivity awarded to orphan drugs manufacturers that garner regulatory approval for their products prohibits this. The biomanufacturing fiasco at Genzyme suggests that it may be time to reexamine the Orphan Drug Act and modify some of the financial and regulatory terms that were included to induce drug companies to develop new treatments for orphan disease indications.

Until next time…

Good Luck and Good Job Hunting!!!!!!!

 

What Prescription Drugs are in Your Future?

Reuters, the news service, published a list of prescription drugs that are predicted to likely to be the top sellers in 2014. For comparison purposes, the forecasts for the top sellers predicted for 2010 were also included.

 

Projected Sales 2010

   

Rank

Brand (Indication)

Company

Sales ($bln)

1

Lipitor (cholesterol)

Pfizer

              11.7

2

Plavix (clotting)

Sanofi Aventis

                9.6

3

Advair(asthma-COPD)

GSK

                9.0

4

Remicade (arthritis)

J&J

                7.4

5

Enbrel (arthritis)

Pfizer

                7.0

6

Humira (arthritis)

Abbott

                6.8

7

Avastin (cancer)

Roche

                6.7

8

Rituxan (cancer)

Roche

                6.1

9

Diovan (hypertension)

Novartis

                6.0

10

Crestor (cholesterol)

AstraZeneca

                5.8

       
 

Projected Sales 2014

 

Rank

Brand (Indication)

Company

Sales ($bln)

1

Avastin (cancer)

Roche

                8.9

2

Humira (arthritis)

Abbott

                8.5

3

Enbrel (arthritis)

Pfizer

                8.0

4

Crestor (cholesterol)

AstraZeneca

                7.7

5

Remicade (arthritis)

J&J

                7.6

6

Rituxan (cancer)

Roche

                7.4

7

Lantus (diabetes)

Sanofi Aventis

                7.1

8

Advair(asthma-COPD)

GSK

                6.8

9

Herceptin (cancer)

Roche

                6.4

10

Novolog (diabetes)

Novo Nordisk

                5.7

 

A quick perusal of the list suggests that there will likely be a shift toward the use of injected biologics in 2014 as compared with orally bioavailable small molecule drugs.

This should come as no surprise since most major pharmaceutical companies have publicly announced that biologics and biotechnology drugs are the key to their future successes.

Until next time

Good Luck and Good Job Hunting!!!!!

 

More Changes at Novartis

Earlier this year, Dan Vasella, the longtime CEO of the Swiss drug maker Novartis, announced that he was resigning his CEO position to assume a full time role as the Chairman of the company’s board of directors. Joe Jimenez, an American, was appointed as the new CEO.

Today, Novartis announced the departure of Ludwig Hanston, the CEO of the US pharma business unit for the past two years. In addition to his departure, four new business units will be formed and 250 employees will lose their jobs effective May 1, 2010.

The four new business units are being formed to more accurately reflect the needs of patient populations. The new business units include 1) Primary Care, 2) Multiple Sclerosis, 3) Psychiatry/Neuroscience and 4) Respiratory/Transplant/Infectious Disease.

For a more detailed explanation of the changes taking place at Novartis please read the post on today’s Pharmalot blog.

Hat tip to Ed.

Until next time…

Good Luck and Good Job Hunting!!!!!

 

Ranbaxy to Hire 1,500 Marketing and Sales Employees to Boldly Go Where No Indian Pharmaceutical Company Has Gone Before

One economic downturn and it seems as though the pharmaceutical world has been turned upside down! Who would have thought a few years ago that emerging pharmaceutical markets in India and Asia will outpace the US and Western European markets in the very near future (I did but nobody listens to me). To that end, Ranbaxy Laboratories will hire nearly 1,500 marketing executives, expanding its sales team by at least 50%, to spur sales and regain its rank as India’s top drug maker. The recruitment push is among the biggest by an Indian drug maker in recent years.  Ironically, pharma sales reps are still being regularly layed off in the US.

The company plans to hire mostly medical representatives, regional managers and area managers by July to boost sales in the rural markets.  According to a Ranbaxy hiring manager “Ranbaxy is looking at new rural markets and deeper penetration in interior markets.”

Ranbaxy is owned by Japan’s Daiichi Sankyo which employs over 12,000 people in 46 countries.

Industry analysts suggest that Ranbaxy’s aggressive hiring push is a sign that the company is focusing on internal markets which are poised for exponential growth in the next few years. Also, Ranbaxy has had its share of legal and regulatory disputes over patents and generics drugs in the US and Western Europe signaling that the company may be pursuing those markets less aggressively than in the past.

Until next time…

Good Luck and Good Job Hunting!!!!!!!

 

US Sale of Prescription Drugs Tops $300 Billion in 2009

IMS Health, a market intelligence company that tracks US drug prescriptions, reported that the US sale of prescription drugs grew 5.1% in 2009 to $300.3 billion.

IMS identified the following key trends among the major therapeutic areas:

  • Antipsychotics remained the top-selling class of medications in the U.S., with 2009 prescription sales of $14.6 billion, equal to the 2008 level.
  • Lipid regulators continued as the largest therapy class in the U.S. by dispensed prescription volume, growing at a 5 percent pace to 212 million prescriptions dispensed in 2009. Sales of lipid regulators declined 10 percent last year to $13.1 billion, reflecting an ongoing shift toward lower-cost generic alternatives. Lipid regulators ranked #3 in overall sales in 2009.
  • Proton pump inhibitors replaced lipid regulators as the second-largest therapeutic class in sales last year. Proton pump inhibitors sales totaled $13.6 billion, a 2 percent decline year over year, while dispensed prescription volume for this therapeutic class rose 5 percent.
  • Antidepressants became the fourth-largest class in 2009, up from its #5 ranking the prior year, with U.S. prescription sales growth of 3 percent to $9.9 billion.
  • Sales of antineoplastic monoclonal antibodies, a leading oncology class that includes Avastin®, Rituxan® and Herceptin®, grew at a 9 percent pace in 2009 and ranked #6 in therapeutic class sales.

IMS also reported that use of generic products, including branded generics, continued to rise last year and now represent 75 percent of all dispensed prescriptions in the U.S., up from 57 percent in 2004. The total number of generic prescriptions dispensed increased 5.9 percent in 2009, while the number of branded prescriptions dispensed declined 7.6 percent.

While the US pharmaceutical and biotechnology industries continue to cry poverty, it appears that sale of prescriptions drugs continues to grow at a pretty good rate. Look for increased growth until 2014 when healthcare reform begins to kick in.

Until next time…

Good Luck and Good Job Hunting!!!!!!!

 

Generic Drug Approvals Outpace New Prescription Medications in Europe

As reported in the March issue of Pharmaceutical Technology Europe, figures published by the European Medicines Agency (EMA) showed that the approval rate for new drugs (branded, generics, biosimilars and orphan) increased between 2007 and 2009; however most of the approvals were for generic drugs not new ones.

According to the published figures there were 58 new drug approvals in 2007, 66 in 2008 and 117 in 2009. However, the number of approvals for branded products decreased during this period; 35 in 2009 compared with 41 in 2008 and 59 in 2007. On the other hand, the approval rate for generics skyrocketed with more than 50 in 2009 as compared with 4 in 2008 and 5 in 2007.

Interestingly, biosimilar products didn’t fare as well as small molecule generic drugs with the number of applications and approvals decreasing during the period. For example, in 2007 10 new biosimilar applications were filed as compared with 3 in 2008 and 1 in 2009. Likewise, the number of approved biosimilar products decreased with 5 in 2007, 6 in 2008 and 0 in 2009. This trend suggests that biosimilars, mainly therapeutic proteins are not faring well in the European market. However, this is likely to change as patents begin to expire for monoclonal antibody-based drugs which are increasingly becoming the new drugs of choice for many indications including oncology, inflammation and metabolic diseases. Nevertheless, there is a growing emphasis and trend on developing generic medications as compared with new ones. Expect this trend to continue as patent expiry for many small and large molecule continues to draw near.

Until next time…

Good Luck and Good Job Hunting!!!!!

 

Another Pharma List: Does Size Really Matter?

Ed Silverman who runs the outstanding Pharmalot Blog, today posted a 2009 list of the world’s top 20 pharmaceutical companies. The list was compiled by IMS Health and placement was based on revenues generated from 2009 prescription drug sales.  The numbers in parentheses represent the percent change from the previous year.

FYI, the Pfizer-Wyeth and Merck-Schering Plough acquisitions weren’t included whereas the Roche-Genentech acquisition was. Also, it is interesting to note that Teva, the world’s largest generic drug manufacturer came in at number 11and exhibited the greatest increase in sales in 2009. Expect the Israeli drug giant to move into the top ten next year as generic drug sales continue to out pace those of branded products.

  1. Pfizer - $41.7 billion - (0.8)
  2. Novartis - $36.7 billion - 7.0
  3. Sanofi-Aventis - $35.1 billion - (3.3)
  4. GlaxoSmithKline - $34.3 billion - (3.4)
  5. AstraZeneca - $33.2 billion - (7.8)
  6. Roche - $31.3 billion - (8.6)
  7. Johnson & Johnson - $26.9 billion - (6.6)
  8. Merck - $25.0 billion - (4.1)
  9. Eli Lilly - $19.6 billion - (8.3)
  10. Abbott - $19.4 billion - (5.5)
  11. Teva - $15.7 billion - (12.3)
  12. Bayer - $15.4 billion - (3.9)
  13. Wyeth - $14.8 billion - (2.3)
  14. Amgen - $14.8 billion - (3.1)
  15. Boehringer - $14.6 billion - (10.4)
  16. Takeda - $14.4 billion - (2.1)
  17. Bristol-Myers - $14.2 billion - (5.8)
  18. Schering-Plough - $13.1 billion - (4.3)
  19. Daiichi Sankyo - $8.5 billion - (3.1)
  20. Novo Nordisk - $8.2 billion (11.6)

Hat tip to Pharmalot

Until next time…

Good Luck and Good Job Hunting!!!!!!!

 

AstraZeneca to Freeze Salaries of Its CEO and Other Executives

AstraZeneca today announced that its Chief Executive David Brennan will receive no increase to his base salary this year, as the drug maker continues a freeze for top executives imposed last year due to weak economic conditions.

Brennan's 2010 salary will remain at $1.4 million, the same level since 2008. However, Brennan’s overall compensation has been on the rise for the past few years. His total remuneration, which includes bonus, shares and other items, rose 5% to $4.9 million for 2009, versus $4.7 million for 2008, according to documents recently filed with the Securities and Exchange Commission.

AstraZeneca said the base-salary freeze for 2010 also applies to other senior executives whose responsibilities are unchanged. 

While it is laudable that the company is freezing the base salary of its executives, most of their annual compensation is derived from bonuses, stock grants and options and other perks and benefits. I am certain that the hundreds of thousands of pharmaceutical employees who lost their jobs over the past three years can sleep better at night knowing that pharmaceutical executives are finally feeling the pain and sharing the pain of a down economy.

Hat tip to Ed at Pharmalot!

Until next time…

Good Luck and Good Job Hunting!!!!!!!!!!

 

FDA to Impose Regulatory Sanctions on Genzyme

Orphan drug manufacturer Genzyme today issued a press release that the US Food and Drug Administration (FDA) notified the company that it intends to take enforcement action to ensure that products manufactured at its troubled biomanufacturing facility in Allston Landing, MA are made in compliance with good manufacturing practice regulations.

The agency’s enforcement action will likely result in a consent decree under which a third party would inspect and review the plant’s operation for an extended period and certify compliance with FDA regulations. Under a consent decree, Genzyme also would be required to make payments to the government and could incur other costs.

The Allston Landing facility was experiencing product quality problems for some time before FDA intervened and threatened regulatory action and sanctions against the orphan drug producer. According to the press release Genzyme will:

work cooperatively with the FDA to restore the agency’s confidence in its ability to operate the Allston plant at the highest standards, building on the progress it has made over the past year to address the manufacturing deficiencies at the Allston plant. This progress includes:

  • Retaining a leading quality assurance advisory firm to help develop a comprehensive strategy and risk mitigation plan. More than 30 expert consultants from this firm are currently working at the Allston plant or at other Genzyme manufacturing facilities.
  • Naming a new site head and reorganizing and strengthening the management team at the facility.
  • Hiring two highly regarded industry veterans to serve as President of Global Manufacturing and Corporate Operations and Senior Vice President of Global Product Quality.

While this is not good news for Genzyme, it is great news for patients who rely on Genzyme’s medicines to manage their oft times devastating and potentially life threatening genetically-inherited diseases.

Until next time…

Good Luck and Good Job Hunting!!!!!!!

 

FDA Asks GlaxoSmithKline to Suspend Sale of Its Rotavirus Vaccine

The US Food and Drug Administration (FDA) has advised GlaxoSmithKline (GSK) to suspend sale of Rotarix, its rotavirus vaccine, because it may contain porcine circovirus type 1 (PCV-1) DNA sequences. The FDA and the company both found traces of PCV-1 DNA in the vaccine. It is not clear whether whole virus is in the vaccine or just pieces of its DNA. Luckily, PCV-1 isn’t known to cause disease in humans and infants vaccinated with the vaccine are not likely to experience any health or medical issues..

The agency insists that this is a temporary and cautionary suspension of Rotarix sales. FDA officials are advising physicians to use Merck’s RotaTeq rotavirus vaccine instead, which is made using a different method and which shows no evidence of PCV-1 contamination. Merck and GSK have been vigorously competing for market share in the US vaccine marketplace.

Unfortunately, things haven’t been going well for the highly regarded GSK vaccines division in the past few years. First, the company had trouble getting its anti-cervical cancer vaccine, Cervarix approved in the US. And the company just recently announced that it may not seek regulatory approval for Synflorix, a new pneumococcal disease vaccine that was suppose to compete with Pfizer’s  (formerly Wyeth’s) second generation 13-valent pneumococcal vaccine called Prevnar.

This isn’t the first time that animal DNA sequences have been found in human biotechnology products. Last June, Genzyme was forced to shut down one of its biomanufacturing facilities to clean up viral contamination that had been slowing down production of two of its main products, Cerezyme and Fabrazyme. The virus, Vesivirus 2117, is known to interfere with the growth of Chinese hamster ovary (CHO) cells and is believed to have been introduced through a cell culture nutrient. The virus doesn’t infect humans, but the shutdown cost the company millions in revenue and caused shortages of Cerezyme and Fabrazyme.

Because many vaccine and biotechnology products are manufactured in mammalian tissue culture cell lines, detection of non-human viruses these products are neither uncommon nor unprecedented. However, the recent spate of high profile, virally-contaminated vaccines and biologics suggests that biomanufacturers must be more vigilant when it comes to virus removal and microbiological testing from these products.

Until next time…

Good Luck and Good Job Hunting!!!!!!

 

Biogen Idec Caves to Icahn's Demands

Biogen Idec today announced that Dr. Eric K. Rowinsky and Dr. Stephen A. Sherwin have been appointed to its Board of Directors pursuant to an agreement with Icahn Partners. Dr. Rowinsky was proposed as a nominee to the Board by Icahn Partners and Dr. Sherwin was selected by the Company as part of its process to identify new directors.

"Under the terms of the agreement, Icahn Partners has agreed to vote its shares at the 2010 Annual Meeting for Biogen Idec's nominees, who will include current directors Nancy L. Leaming and Brian S. Posner as well as Drs. Rowinsky and Sherwin. In addition, under the terms of the agreement, Icahn Partners will withdraw its notice of nomination of persons for election as directors and its proposal to amend Biogen Idec's Bylaws to limit the size of the Board."

As you may recall, Icahn tried to wrest control of the company from its current management team in an attempt to force the company to sell itself because Icahn believed that its stock price was undervalued. Since that time, it appears that Biogen Idec executives are seeking to appease Icahn rather than publicly fight with him over the value of the company. Don’t be surprised if Biogen Idec is sold to a large pharmaceutical company by the end of this year.

Until next time…

Good Luck and Good Job Hunting!!!!!!

 

The Bidding War is Over: TEVA to Acquire Ratiopharm

After months of speculation and a nine month-long bidding war, Teva not Pfizer has emerged as the winner to purchase Ratiopharm; the financially-troubled, German generics manufacturer. Ratiopharm was Germany’s second largest generics manufacturer.

Teva Pharmaceutical Industries Ltd announced today that it has entered into a definitive agreement to acquire Ratiopharm, Germany's second largest generics producer (Novartis AG’s Hexal unit is first and Stada Arzneimittel AG is third) and the sixth largest generic drug company worldwide, for €3.625 billion ($ 5.0 billion). Teva expects to complete the transaction by year-end 2010.

The acquisition will position Teva as the leading generic pharmaceutical company in Europe. Ratiopharm's extensive product portfolio includes 500 molecules in over 10,000 presentation forms covering all major therapeutic areas marketed in 26 countries. Also, Ratiopharm has valuable know-how in biosimilars (a market that Teva has entered and is extremely bullish on) which consists number of products in advanced stages of development and a well-established sales and marketing team. The combined company will have 40,000 employees worldwide, of which 18,000 will be based in Europe. The purchase will bolster Teva’s visibility and standing in European markets.

Late last month, Ratiopharm board members implored Pfizer to enter a new bid, after it had rejected an earlier offer by the company. Apparently, the new bid was not sufficient to prevent Teva from acquiring the highly sought after generics manufacturer. Iceland-based generics manufacturer Actavis also put in a failed bid to acquire Ratiopharm.

 

Astra Zeneca Jumps on the Generic Drug Bandwagon

Astra Zeneca announced today that it has agreed to market 18 of Torrent Pharmaceuticals Ltd.’s branded generic drugs in 9 emerging markets, marking the U.K. drugmaker’s first generic-drug partnership.

Unlike some its competitors, Astra Zeneca is very vulnerable to generic competition as many of its best selling products such as Nexium for ulcers, the antipsychotic Seroquel and Crestor for cholesterol. are near patent expiry. Industry analysts expect the company to lose as much as 25% of its sales revenue to generic encroachment by 2014.

The company joins a growing list of big pharma companies including Pfizer, Sanofi-Aventis and GlaxoSmithKline that view generics as a viable replacement for revenues lost to generic competition for it top selling brands.

Last year, GlaxoSmithKline entered into joint ventures with the generic manufacturers Dr. Reddy’s Laboratories (India) and Aspen Pharmacare Ltd (South Africa). Also, the company paid $246.5 million for Bristol-Myers Squibb’s Pakistan and Egypt drug units and acquired UCB’s drug portfolio in Africa, the Middle East, Asia Pacific and Latin America for $702 million; clearing signaling its intention to more aggressively pursue emerging global markets.

Likewise, Sanofi-Aventis bought Zentiva NV of the Czech Republic, Helvepharm AG of Switzerland, Medley SA of Brazil and Laboratorios Kendrick SA of Mexico to bolster its branded generics portfolio. The company also took control of the Indian vaccine and biologics manufacturer Shantha Biotechnics which suggest that Sanofi may be looking to biotech in the future.

Finally, Pfizer continues its pursuit of the financially-troubled German, generics giant Ratiopharm. Actavis of Iceland and the Israeli generics manufacturer Teva have also put in bids to purchase Ratiopharm. However, there are signs that Ratiopharm's board would prefer to be purchased by Pfizer rather than Teva or Actavis.

Look for other big pharma companies to enter into deals with or purchase branded or conventional generics manufacturers.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!

 

The Life Sciences Industry: China Begins to Turn Up the Heat

Until recently, there was little or no mention of business activity within the emerging Chinese life sciences industry. However, as the Chinese middle class continues to grow, the need and demand for pharmaceutical and biotechnology drugs (including vaccines and other biologics continues) to grow at a frenetic pace. Further, a growing abundance of US-trained scientists has allowed the Chinese life science industry to develop much more quickly than anticipated. Also, many major pharmaceutical companies like Merck, Roche and Novartis have invested hundreds of millions of dollars in China and have already established world class Chinese R&D facilities. Finally, unlike in most Western countries, the Chinese government controls roughly 80% of the pharmaceutical and biologics manufacturing that takes place in China. Together, this suggests that China has quietly established itself as a life sciences power to be reckoned with! To that end, there were two reports that came across the transom this morning that piqued my interest. 

The first report was about a company called Lotus Pharmaceuticals, Inc.

"Lotus Pharmaceuticals, Inc., a growing developer and producer of prescription drugs and licensed national seller of pharmaceutical products in the People's Republic of China ("PRC"), reported the groundbreaking ceremony on March 9 to construct a new building complex on the grounds of its production facility in Beijing.

Officials of Beijing municipal and Chaoyang district governments, officers of the China State Food & Drug, and representatives of both state-owned and private pharmaceutical companies attended the ceremony. CEO, Zhongyi Liu, welcomed the guests. "After a year of planning, we are pleased to start the construction of the new building complex and expect to finish the construction by July, interior decoration by September and GMP certification by December of this year," he said. "This is a new page for Lotus' development and it will provide important impetus to profitable growth, which is anticipated to reach $150 million in annual sales during the first year after the facility, is fully operational."

The second reported on plans to build a venture-back, “private” contract manufacturing facility that specializes in biomanufacturing in metropolitan Beijing.

"AutekBio, Inc., SUMA Ventures and Beijing E-Town Harvest International Capital Management Corporation, a venture capital group from Beijing Municipal Government announced a joint investment of more than US$100m to develop a new contract manufacturing organization (CMO) for biopharmaceutical industry in China. This joint effort led by AutekBio represents strong interests from both private investment sector and government to establish world quality capability and capacity in biopharmaceutical manufacturing in China.

The new joint venture will build up a world class R&D and manufacturing center in southern Beijing to service international biologic developments, with combined volumes of bioreactors up to 20,000 liters in multiple production lines (trains). The firm will also benefit from financial, regulatory and other supports from the Chinese government for the biotech industry." 

It is becoming increasingly apparent that China has clearly set its sights on establishing itself as player on the global life sciences stage. After spending a week in China during the country’s preparation for the Beijing Games, I discovered that China can achieve any goal that it sets for itself in very short order.  

Until next time...  

Good Luck and Good Job Hunting (try China)!!!!!! 

 

Another Biotech Company Bites the Dust

Abbott Laboratories yesterday announced that it will buy Facet Biotech Corp. for about $450 million in cash. Facet, along with its development partner Biogen Idec, had planned on moving a potential monoclonal antibody (MAb) treatment for multiple sclerosis called daclizumab into late stage clinical development in the second quarter of this year. The company is also developing several different cancer treatments with other pharmaceutical partners.

Abbott’s purchase of Facet signals Abbott Laboratories’ ongoing commitment to biotechnology or protein-based drugs. The company launched Humira (a fully human MAb treatment for rheumatoid arthritis and other inflammatory diseases) several years ago and it has managed to glean market share from older competitor’s products including Remicade (Johnson & Johnson) and Enbrel (Amgen/Pfizer) to become a blockbuster drug. MAbs are viewed by many as the “drugs of the future.” At present, there are over 350 MAb-based products in various stages of discovery and clinical development.

Earlier in the year, Biogen Idec offered to purchase Facet for $17.50 per share. Company executives and shareholders rejected the offer citing that they thought it was too low. Abbott offered $27 per share which represented a 67 percent premium to Facet’s closing stock price of $16.21 on Tuesday.  Both companies’ boards of directors have already approved the deal which is expected to close some time in the second quarter. It is not clear how the purchase will affect Facet employees but expect to see layoffs and a mass exodus by company executives.

Look for more cash purchases of biotech firms by pharmaceutical companies as debt continues to accrue and venture money remains scarce and difficult to come by.

Until next time...

Good Luck and Good Job Hunting!!!

 

Why Five Years of Data Exclusivity Makes Sense for US Follow-on Biologics Legislation

In case you did not know, the 12 years of market exclusivity proposed for follow-on biologics by supporters and lobbyists for the pharmaceutical and biotechnology industries is part of the impending US healthcare reform legislation currently pending in Congress. While President Obama has publicly announced that he supports a five year period of data exclusivity for biologics (the same as the exclusivity period for generic small molecule drugs, it is unlikely that the President will be able to convince or coerce legislators to reconsider the 12 year data exclusivity provision. However, there was a brilliant Op-Ed piece in today’s New York Times written by Anthony So and Samuel Katz at Duke University which offers a plethora of financial and business reasons why the five year period makes a lot of sense!

  1. Generic small molecule drugs have been estimated to save the American healthcare system as much as $734 billion over the past 25 year or so since the inception of the Hatch Waxman Act.
  2. Biologics cost on average 22 times more than equivalent brand name prescription small molecule drugs
  3. In 2008, 28% of sales of the life science industry’s top 100 products came from biologics and biotechnology products: by 2014 that share is expect to rise to about 50%
  4. The Medicare Payment Advisory Commission found that the top six selling biologics which include Epogen (Amgen) Avastin (Genentech) and Remicade (Centocor) accounted for $7.0 billion (43%) of Part B drug spending in 2007 (Part B covers the cost of doctor spending and outpatient visits)
  5. Between 2006 and 2007, Medicare Part D (prescription drug coverage) spending on biologics increased by 36% as compared with a 22% increase in spending for small molecule drugs
  6. Prices for biologics and biotechnology products have increased more rapidly than those for small molecule drugs
  7. While industry leaders and their lobbyist contend that it costs more and takes longer to develop biologics and biotechnology products than small molecule drugs, based on reports by various industry trade groups it costs about $1.2 billion to develop biologics and roughly $1.318 billion for small molecule drugs
  8. The US Federal Trade Commission, the independent federal agency whose main goals are to protect consumers and to ensure a strong competitive market by enforcing a variety of consumer protection and antitrust laws, recommended that the data exclusivity period for follow-on biologics should not exceed six years.

Despite the likelihood that follow-on biologics will substantially reduce prescription drug costs and healthcare spending, Congress has chosen to support questionable legislation that will delay access of Americans to less costly, efficacious follow-on biologics until at least 2020.

Until next time...

Good Luck and Good Job Hunting

 

BioJobBlog Makes a Top 50 Biotech Blog List

Emily Johnston of Medicareer sent me a message last night to inform me that BioJobBlog made its top 50 biotech blog list. While I don’t know much about Medicareer (nor does BioJobBlog have a business or financial relationship with the organization) this is a first for the blog and it is quite an honor to be included on the list. I guess spending hundreds of hours over the past three years writing blog posts is actually beginning to pay off!

A quick perusal of the list reveals some very interesting and useful biotechnology blogs that are worth reading. And, surprisingly, there are a couple of blogs on the list that I previously didn’t know about.

Hat tip to Medicareer!

Until next time...

Good Luck and Good Blogging

 

Merger Mania Continues in the Life Sciences Sector

Merck of Germany announced on Sunday that it had agreed to purchase Millipore, an American supplier of laboratory products and reagents for biotechnology companies for $7.2 billion. The offer comes in the wake of the $6.0 billion offer made last week by Thermo Fisher Scientific one of the largest supplier in the world of laboratory reagents, supplies and equipment. While somewhat of an unconventional move for a healthcare company, Merck executives hailed the acquisition as a strategic move for customers, stakeholders and share holders of both companies.

In other news, Astellas Pharmaceuticals, Japan’s second largest pharmaceutical company said today that it tendered an offer to acquire all outstanding shares of Long Island, NY-based OSI Pharmaceuticals for $52.00 per share or approximately $3.5 billion in cash. OSI, which manufactures and sells Tarceva (erlontinib) a treatment for non-small cell lung and pancreatic cancer (which it co-markets by Genentech in the US and globally with Roche), has a strong oncology pipeline and is also developing treatments for diabetes and obesity. Despite early success with Tarceva, cash-starved OSI has been struggling of late. The acquisition of OSI provides Astellas with a strong pipeline and entrée into the growing US oncology market. OSI would also complement Astellas’ existing strength and franchises in urology and immunology.

While mergers and acquisitions were largely anticipated in the US biopharmaceutical sector over the past few years, the acquisition of American companies like Millipore and OSI Pharmaceuticals by foreign companies suggests that there may be chinks in the armor of once dominant US biotechnology companies. The economic crisis coupled with America’s waning innovation in the life sciences sector suggests that other US-based biopharmaceutical companies may be at risk. Although most foreign governments stumbled when attempting to develop the own internal biotechnology expertise, many cash-rich foreign companies recognize that purchasing US companies with marketed products offers them an opportunity to quickly and strategically gain a foothold in the ever-expanding biotechnology market.

Until next time....

Good Luck and Good Buying!!!!!!!!!

 

Economic Recovery: US Contract Biomanufacturing Companies Are Experiencing an Upswing

For the past decade or more, small to mid-sized biotechnology companies had been outsourcing production of their preclinical and clinical protein-based products to Asian contract manufacturing organizations (CMOs). This was because manufacturing and labor costs were lower and product quality was consistent with Western standards and requirements. However, the recent economic down turn coupled with rising prices at Asian CMOs (mainly driven by increasing labor and project management costs) has forced many small to mid-sized companies to rely again on American CMOs to manufacture their products. Unlike cash-rich, larger companies, US small to midsize companies generally lack the financial resources and personnel to effectively manage operations in Asia. Many industry analysts contend that the lower initial costs of Asia-based companies are usually offset by the money and resources need to oversee a project.

While business returning from Asia improved the financial outlook for some American CMOs, 2009 was a bad year for most firms that service small to mid-sized pharma and biotech companies. However, industry analysts expect 2010 to be better than 2009. More importantly, the return of biomanufacturing to the US may signal the beginning of a new trend in the biomanufacturing outsourcing industry.

Until next time....

Good Luck and Good Job Hunting!!!!!!!!!!

 

Carl Icahn Takes Aim:Setting His Sights on Genzyme

Carl Ichan, the billionaire, activist investor notified Genzyme that he will seek shareholder approval to seat four handpicked directors including himself to be appointed to the company’s board of directors in an attempt to remove embattled Chairman and CEO Henri Termeer who has led the company for the past 25 years.

The move was widely anticipated by industry analysts because Icahn own one percent of outstanding shares of Genzyme’s stock.  Icahn and other large shareholders believe the company would be better off under new leadership. Termeer has publicly stated that he has no intention of resigning.

Until recently, Genzyme’s standing and reputation in the biopharmaceutical and orphan drug industry was second-to-none. However, the company’s inability to quickly correct ongoing manufacturing problems at its biomanufacturing facilities for the past year has been extremely embarrassing and costly. Sloppy manufacturing and quality control problems this past year led to major shortages of two main products, Cerezyme and Fabrazyme. Consequently, in 2009 sales revenues dropped and company earnings were almost flat. Further, Genzyme shares lost 26% of their value in 2009, sinking to a five-year low.

Icahn is no stranger to hostile corporate takeovers and company sales. In spring of 2008, he unsuccessfully tried to gain control of the Biogen/Idec board to force the sale of the company (Ichan owns 5.6% of Biogen/Idec’s outstanding shares). Later that year, Icahn engineered the sale of ImClone to Eli Lilly for $7.0 billion; after getting into a very public and often acrimonious fight with Bristol-Myers Squibb CEO Jim Cornelius who tendered a “low-ball offer” (according to Icahn) to purchase ImClone.

According to my calculations, Icahn is batting .500 for his recent corporate takeover attempts. Do you think he will be able to go 2-for-3? I bet Henri Termeer is hoping that he can’t!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!!

 

Some Things You May Not Know About Generic Drugs

The rising cost of healthcare, increasing drug prices and the restrictive nature of the formularies of many insurers and third party payers is forcing a growing number of Americans to rely almost exclusively on generic prescription drugs. The trouble is that most Americans know very little about generic drugs; mainly because big pharma has done its best to minimize the discussion about generics and continues to portray generic manufacturers as less than reputable purveyors of prescription drugs. Because of this, I think that American ought to begin to understand an industry that increasingly will play a major role in the US healthcare system. So here goes:

  1. According to IMS Health, generic drugs accounted for 70 percent of the 2.9 billion prescriptions filled in the US in 2009
  2. Generic drugs accounted for only 15 percent of almost $300 billion spent on prescription drugs last year in the US
  3. Since 2003, the US Food and Drug Administration (FDA) received 800 new generic drugs applications; up from an average of 330 applications per year in the last decade
  4. Five years ago, it took FDA regulators an average of 16.3 months to review and approve generic new drug applications; by 2009 the average time to approval had ballooned to 27.7 months
  5. There is a backlog of nearly 2,000 pending generic new drug applications, almost double the backlog at the agency in 2005
  6. FDA’s division of generics had a budget of only $41 million in 2009; its budget for 2010 is $511 million
  7. Unlike branded pharmaceuticals, companies seeking regulatory approval for new generic drugs don’t pay user fees
  8. According to FDA Commissioner Dr. Margaret Hamburg generics saved American consumers almost $750 billion over the last decade.

Based on these facts, it is evident that FDA is seriously under funded, under staffed and overwhelmed by the spike of new generic drug applications in recent years. Interestingly, President Obama’s proposed 2010 budget included $38 million in user fees from generic manufacturers to process new drug applications. Not surprisingly, generic manufacturers are not willing to pay these fees unless the approval time for their products is drastically shortened. To that end, FDA is hiring 50 more reviewers and hopes that personnel increases will eliminate the generic drug application backlog by 2012. 

Dr. Hamburg is also looking to streamline some aspects of the generic drug application review process. For example, she proposed giving higher priority to generic drugs applications for branded drugs whose patent expiry is imminent as compared with applications for drugs that have several more years of patent protection remaining.

Nevertheless, the bottom line is that the agency needs a much larger budget and staff to keep up with the ongoing torrent of new generic drug application. With this in mind, the agency ought to consider reallocating existing resources—rather than wait for budget increases in these financially uncertain times—to process new generic drug applications in a timely fashion. This may be possible because of the annual number of drug applications for new, branded prescription drugs has steadily been decreasing for the past five years.

Hat tip to the New York Times!

Until next time...

Good Luck and Good Job Hunting!!!!!!

 

Branded Generics: Something Old, Something New?

Earlier this week, an article appeared in the NY Times Business section heralding the entry of several large pharmaceutical companies into the branded generics industry. For those of you who may not know, generic drugs are lower cost versions of brand name prescription drugs that have lost patent protection. Generic prescription drugs are usually much cheaper than their brand name counterparts but generally deliver the same therapeutic effects as the branded product. In most cases, so-called “commodity generic drugs” are not branded and sold to consumers by their chemical names. A good example of a commodity generic drug is the anti-depressant sertraline HCl; which Pfizer sells under the brand name Zoloft. Pfizer still manufactures and sells Zoloft but Zoloft lost patent protection several years ago and a generic version of the active ingredient, sertraline HCl, is now available to consumers. Because sertraline HCl is much cheaper than Zoloft, pharmacists almost always substitute prescriptions for Zoloft with sertraline HCl. This is perfectly acceptable because sertraline HCl was approved by the US Food and Drug administration with an AB rating which means that sertraline HCl is biologically equivalent to Zoloft.

Unlike commoditized (no-name) generics, branded generics are off-patent prescription drugs that are sold to consumers—as the name implies—under a brand name. Typically, because these products are “branded” and actively marketed by manufacturers they are sold at higher prices than equivalent no-name generics. This is because consumers are generally willing to pay more for drugs that are manufactured by well known and trusted companies as compared with no-name generics which are usually produced by lesser known or unidentified manufacturers.

Branded generics are not a new or novel concept. They were previously championed by a number of generics manufacturers, most notably Barr Laboratories, which was recently purchased by the Israeli generics giant TEVA. In the past, when pharma embraced the blockbuster drug business model, drug manufacturers built in revenues— that eventually would be lost through patent expiry—into the price of their top selling drugs. This allows drug companies to maximize ROI early in a drug’s life cycle years before patent expiry Studies have shown that branded prescription drugs can lose as much as 90% of their original value two years after the introduction of generic equivalents. Consequently, because of drastically diminishing financial returns after patent expiry, it didn’t make economic sense to continue to promote and support a brand that was facing generic competition. Put simply, the company made its money on the drug and it is time to move on. 

However, the emergence in recent years of an affluent middle class in developing markets like China, India, Brazil, Eastern Europe and elsewhere is causing branded pharmaceutical companies to reconsider their generics strategy. In these markets, many people frequently pay out of pocket for their medicines but cannot afford to pay for the expensive brand name drugs. Also, in some emerging markets, where the threat of low quality or counterfeit prescription drugs may be high, consumers who can afford to purchase medicines are willing to pay more for drugs manufactured by well known and respected companies. Finally, IMS Health estimates that close to $89 billion in US drug sales alone will be lost to generic competition over the next five years or so.

In the absence of any new blockbuster drugs on the horizon, many big pharma companies have been scrambling to acquire or enter into relationship with established regional generic manufacturers. For example, GlaxoSmithKline recently bought a stake in Aspen a South African generics manufacturer and entered into an agreement with India-based Dr. Reddy’s laboratory to sell generic products in Asia and other emerging markets. Likewise, in the last year, Pfizer created an off-patent generics division (products are sold under Greenstone label which is a wholly owned subsidiary of Pfizer) and signed agreements with three Indian companies to sell their products in the US and other markets. These deals added about 200 products to Pfizer’s new generics portfolio. Further, Pfizer recently announced that the Greenstone brand has become the world’s seventh largest generics seller. In addition, Pfizer is expected to make a formal bid to purchase the financially-troubled German generics manufacturer Ratiopharm; one of Germany’s largest purveyor of generic drugs.

Not to be outdone by the competition, the French drug maker Sanofi-Aventis recently purchased Brazil-based Medley, a dominant player in the South American branded generics industry and Laboratorios Kendrik, a Mexican generics producer. Last year, the company also purchased Zentiva, a leading Czech generic manufacturer signally the company’s intention to move into financially-lucrative Eastern European markets.

Watson, one of the largest American generics manufacturers (which primarily operates in the US) recently purchased Arrow, a generic producer that operates in 20 different countries. Finally, Novartis, recognizing a business opportunity before most of its competitors, entered the generic market in 2003 following creation of Sandoz, a division of Novartis that manufactures and sells small molecule generic drugs and branded biosimilar products. Recently, Novartis purchased the German branded generics manufacturer Hexal, making it the world’s second largest generic drug manufacturer after Teva.

The entry of pharmaceutical companies into the generics business is allowing these companies to pursue a two-tiered business strategy in certain markets which is designed to preserve the long term value of their branded franchises. For example, companies can continue to sell their expensive name-brand drugs to the wealthy (or those that can afford them) and concurrently sell the more moderately priced branded generics which includes and over the counter products to the broader market. 

While some may lament the end of the blockbuster drug era, rising healthcare costs and generic competition is forcing big pharma to continue to explore novel and innovative strategies to reinvent itself.

Until next time...

Good Luck and Good Job Hunting (try the generic industry; business is booming)

 

Second Acts: ImClone Founder Sam Waksal is Seeking Investors for a New Biotechnology Company

As many of you may recall, in 2001, Sam Waksal, founder and former CEO of the biotechnology company ImClone was convicted (along with his good friend Martha Stewart) for fraud and insider trading of ImClone stock. Waksal, who was released from prison in late 2008 and lived in a half way house for several months had kept a relatively low profile until earlier this month. Rumor has it that Sam along with Richard Mulligan, PhD a Harvard professor and former ImClone director and Dr. Larry Witte, a current executive vice president in the ImClone division of Eli Lilly are attempting raise about $50 million for the privately-held new venture called Kadmon. Other reports indicate that Waksal and other members of the Kadmon team are putting up $50 million as well. 

According to insider reports the company will ostensibly focus on cancer and infectious disease targets and—taking a page out of the Cubist, Celgene and Sepracor play books—re-purpose once promising drug candidates discarded by other companies. To that end, according an article in TheStreet, the company's drug research programs include a "statin inhibitor for influenza" from a "leading Ivy League university" along with a variety of monoclonal antibodies for use as targeted cancer treatments, similar to Erbitux. Kadmon is also eyeing several existing cancer-focused drug companies, one of which already has a marketed product, as acquisition targets, according to the prospectus. For those of you who may be wondering about whether or not Waksal can legally start another biotechnology company, an agreement with the Securities and Exchange Commission bars Waksal from serving as an officer in a publicly traded company, but as previously mentioned, Kadmon is a private venture.

Whether you like Waksal or not, his track record in the biotechnology industry speaks for itself. Unlike the vast majority of his rivals, Waksal shepherded a molecule from discovery through commercialization. That molecule, a monoclonal antibody called Erbitux, became a multibillion dollar a year treatment for certain forms of colorectal cancer. More importantly, Waksal was one of the first to recognize that humanized monoclonal antibodies directed against certain cellular receptors could be used to treat a variety of oncology indications—a concept that is driving a large portion of discovery and product development in the oncology space. For those of you who may not know, Eli Lilly purchased ImClone two years ago for $7.0 billion dollars after a very public and acrimonious fight over the sale price of ImClone erupted between Carl Icahn, ImClone’s Chairman, and Jim Cornelius, CEO of Bristol-Myers Squibb (BMS). ImClone and BMS co-marketed Eribitux prior to the sale.

Waksal has been in and around the biotechnology industry for over 30 years and many consider him to be one of the early industry pioneers. Unfortunately, despite his dubious past, Waksal represents a dying breed of visionaries whose entrepreneurial spirit and unorthodox approach to new drug development is largely responsible the biotechnology industry’s current largess. Like other ex-felons Waksal did his time and like all Americans he is entitled to a second chance.

Let’s hope that Sam learned a few things during his incarceration and is smarter and wiser for his second and possibly final act. I wish Waksal success in his new venture and I hope that he and his team still possess the insight, creativity and tenacity required to discover and develop innovative oncology and infectious diseases drugs.

Until next time....

Good Luck and Good Job Hunting!!!!!!!

 

GlaxoSmithKline to Increase the Size of its Sales and Marketing Team in India

According to an article that appeared in the Indian publication The Hindu Business Line, GlaxoSmithKline (GSK) is set to increase the size of its Indian marketing and sales force to better support the sale of vaccines and other specialty products. A company executive said that GSK will add another 200 people to its 2,250 member sales and marketing team.

GSK is repositioning itself to be more competitive in developing and emerging markets like India, China, Brazil and elsewhere. The announcement to increase the size of its workforce in India comes only a couple of weeks after the company announced massive global layoffs that would affect at least 4,000 GSK employees.

Hat tip to Ed at Pharmalot!

Until next time...

Good Luck and Good Job Hunting!!!!!!

 

Fred Hassan Shares His Views on the Past, Present and Future of the Pharmaceutical Industry

I just received a phone call from UK-based Meettheboss.TV to give me advance notice of an interview that was conducted with Fred Hassan, the former CEO of Schering Plough, that will be shown tomorrow at the Meettheboss.TV website. Hassan stepped aside as CEO after Merck acquired Schering Plough for $41.1 billion late last year.

Mr Hassan is arguably one of the most respected and highly visible pharmaceutical executives in the industry. He sat down with Meettheboss.TV to share how he was able to turn around a dysfunctional and failing Schering Plough and restore its tarnished image.

“I joined a company in 1997 that was in great difficulty.  There has been a merger between a Swedish company and a U.S. company, and that merger had resulted in a lot of difficulties, I was brought in as a CEO from the outside to try to make this merger work.  I realized that the future growth product of this company has been compromised in a deal that had to be untangled.” Fred told Meettheboss.tv

In an uncharacteristically candid interview, Hassan also offers his personal insights and views on the challenges that the pharmaceutical industry faces in the future as traditional business models begin to change and new players enter the pharmaceutical industry space. 

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To watch the full interview, please visit Meettheboss.TV

Until next time....

Good Luck and Good Viewing!!!!!!!!

PhRMA Shakeup: Au Revoir Billy Tauzin

Billy Tauzin, a former Congressman and high profile lobbyist, unexpectedly resigned as President of the Pharmaceutical Research and Manufacturers of America, (PhRMA), a pharmaceutical industry lobby and trade organization. According to a report in today’s New York Times, his resignation resulted from internal disputes over PhRMA’s pact with the White House to trade political support for favorable terms in the proposed health care reform bill. The trade group issued a news release on Thursday night confirming Mr. Tauzin’s departure, effective June 30.

When he first took the helm at PhRMA in 2005, Tauzin’s publicly-stated goal was to improve the group’s image and reduce the “number of its enemies.” Prior to Tauzin’s arrival at PhRMA, it was an obscure lobbying group that was little more than a “rubber stamp” for the agenda set by pharmaceutical companies. Under Tauzin's tutelage, the trade group adopted a more progressive strategy and tried to set a new agenda for the pharmaceutical industry.

In exchange for favorable terms in the original Obama healthcare reform package, PhRMA spent more than $100 million on ads to promote the overhaul. But after healthcare reform stalled, some industry leaders felt the trade group had gone too far giving concessions and could lose on some important legislative issues without gaining the political protection it had sought.

Despite publicly accusing the White House of reneging on its original deal, Tauzin’s willingness and zeal to help to reform healthcare ultimately led to his demise. I suspect that the next person chosen to lead PhRMA will likely be a pharma insider willing to "tow the party line."  While I wasn’t originally keen on Tauzin’s appointment, he proved to be an extremely effective  leader, who unlike most of his PhRMA predecessors, was forward-thinking and had a clear vision for the future of an industry currently in transition.

Tauzin’s departure signals that many pharma executives believe that healthcare reform is dead and companies can continue with “business as usual.” While failed healthcare reform may be beneficial to big pharma in the short term, it ultimately may lead to pharmaceutical price control legislation. This is because—in the absence of healthcare reform— drug and devices prices will continue to skyrocket and  legislators will have little choice but to regulate and cap drug and devices prices.

Until next time,

Good Luck and Good Job Hunting!!!!!!!

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Rare Disease Day: FDA to Offer Orphan Drug Development Workshop

A rare or orphan disease is defined in the US as one that affects fewer than 200,000 at any given time. It is estimated that there are 6000 to 8000 rare diseases in the world today. Because the number of patients afflicted with orphan diseases is so small, drug companies have historically been reluctant to invest money to discover and develop new treatments for them. The dearth of treatments for rare diseases induced Congress to pass the Orphan Drug Act in 1983 which provided market exclusivity, tax breaks and incentives and regulatory help for companies to development new drugs for orphan disease indications.

While many current blockbuster drugs including recombinant human insulin, growth hormone and erythropoietin originally garnered regulatory approval after receiving orphan status in the late 1980s, most big pharma and biotechnology companies (except Genzyme) largely abandoned orphan drug development until recently. The renewed interest in orphan drug development has been primarily driven by the demise of big pharma’s blockbuster business model that began in the early 2000s. The search for new, non-blockbuster drugs and fresh markets is what induced Pfizer, the world’s largest pharmaceutical company, to recently inked a multimillion dollar deal with Protalix Biotherapeutics, a small biopharmaceutical company developing a new treatment for Gaucher disease—an orphan indication.

Because of renewed interest and the ever increasing need for new orphan drugs, the FDA’s Office of Orphan Products Development is offering an Orphan Drug Designation Workshop that will provide a unique opportunity for all potential drug sponsors—including biotechnology companies, pharmaceutical firms and academic institutions—to learn about the application process for orphan drug designation.

The National Organization for Rare Disorders (NORD) is a co-sponsor of the workshops, which will take place on February 25-26 at Keck Graduate Institute and August 3-4 at the University of Minnesota.

Participants are encouraged to bring specific product proposals for at least one candidate orphan drug that holds promise for the treatment of a rare disease. A significant portion of the workshop will be dedicated to preparing applications, including one-on-one guidance sessions with FDA staff members. FDA will keep product and disease information confidential.

Final applications can be submitted to the FDA at the close of each workshop. For information or to register:

FDA Workshop Brochure
Registration for the February Workshop

Finally, February 28th is Rare Disease Day. The event is sponsored by the EURODIS a European advocacy group that promotes awareness and research for rare diseases. NORD and Discovery Health are also sponsoring the day.

Until next time....

Good Luck and Good Job Hunting!!!!!!!!!

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Why Generic Drug Companies Will Dominate Future Pharmaceutical Markets

The loss of over 200,000 pharmaceutical jobs over the past three years has been mainly driven by the anticipated loss of revenue from blockbuster drugs that will lose patent protection by 2013. While drug makers frequently cite blockbuster patent expiry as the reason for the need to downsize, they rarely provide the business and economic metrics, numbers and statistics that have influenced their decisions. 

Patricia Van Arnum, Senior Editor of Pharmaceutical Technology wrote a fascinating article in this month’s issue of Pharmaceutical Technology Europe that skillfully outlined the economic forces that are driving branded pharmaceutical companies to downsize and reorganize. According to the article, in October 2009 the pharmaceutical intelligence firm IMS estimated that the global pharmaceutical market is expected to growth 4-6% in 2010 and reach $825 billion. Market growth at an annual rate of 4-7% is expected to continue through 2013 and the size of global pharmaceutical market is projected to exceed $975 billion. The US pharmaceutical market, the largest in the world, is expected to drive much of this growth. However, the growth of the American market is only expected to be 3.5% in 2010. In market contrast, China’s pharmaceutical market is expected to increase by a staggering 20% per year and contribute 21% to the overall growth of the global pharmaceutical market by 2013. 

While prospects for the US market are better than originally anticipated, the loss of nearly $137 billion in revenues in 2013— because of patent expiry of blockbuster products—coupled with fewer new drug approvals are the factors that will limit the growth of the global pharmaceutical market to single digits through 2013 and likely beyond. Some of the drugs slated to lose patent protection by 2013 include Lipitor (atorvastatin) by Pfizer, Plavix (clopidogrel) by Sanofi-Aventis and Bristol-Myers Squibb and Seretide/Advair (salmeterol and fluticasone) by GlaxoSmithKline. Lipitor, Plavix and Seretide were the number one-, two- and foruth best-selling drugs in 2008 with global sales of $13.7 billion, $8.6 billion and $7.7 billion respectively.

The increasing growth of the generic pharmaceutical industry is best reflected in the concomitant growth of merchant active pharmaceutical ingredient (API) manufacturing industry. In the API world, there are two types of manufacturers; the so-called captive API producers or companies that exclusively manufacture APIs for finished, branded products and merchant manufacturers which are third party providers of APIs. Over the past four years or so, the growth of the merchant API market for generic products has substantially outpaced the growth of the API for innovator products. For example, from 2004-2008 the merchant market for generics grew at an average annual rate of 9.1% from $12 billion in 2004 to $17 billion in 2008 according to a recent report by the Chemical Pharmaceutical Association (CPA). In contrast, the CPA determined that the merchant market for innovator/branded APIs only increased at an average annual rate of 4.4% from $16 billion in 2004 to $19 billion in 2008. Looking ahead, the worldwide market for merchant APIs is projected to grow at an average annual growth rate of 6.8% through 2013 to about $50 billion. During this period, growth of innovator APIs is expected to be about 1.8% whereas the growth of generic API is expected to be a robust 11.4%.

The US is currently the largest market for generic APIs and consumed roughly 22.9% of the total global demand for generic APIs in 2008. China, which is the second largest consumer of generic APIs, consumed 19.2%. While the US is expected to remain the largest consumer of both innovator and generic APIs, China is projected to become the largest consumer of generic APIs in 2013 capturing a 26% share of the total generic API market (the US will be number 2 with 20.5% market share).

According to industry analysts, China, India, Latin America and Central and Eastern Europe (most notably Russia), represent attractive growth opportunities for generic APIs. India and China now account for roughly 25% of the global generic market and demand in these countries is expected to remain strong for the foreseeable future as the middle class continues to emerge. To that end, China is projected to have the highest average annual growth rate at 18.4% and India’s market will grow by 14% through 2013. Similar growth is expected for the Eastern European, Russian and Brazilian generic API markets.

While the economic size of emerging generic markets is still small compared with those of the US, Western Europe and Japan, it signals that generic drugs will likely drive the future growth of the pharmaceutical industry. The lack of innovation and rising costs of branded, prescription drugs in developed nations is the main driving force behind the rapid emergence of the generic drug industry. That said, is it any wonder why Pfizer is thinking about entering the generic pharmaceutical business and that Western drug companies are shedding scientists and sales people in the US and Europe and growing the sizes of their R&D and sales force staffs in Asia, Eastern Europe and Latin America? Honestly, if I had any money left to invest, I would seriously be considering traded generic pharmaceutical manufacturers—their future success is almost guaranteed!

Until next time...

Good Luck and Good Job Hunting!!!!!!!

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The Carnage Continues: GlaxoSmithKline to Slash an Additional 4,000 Jobs

GlaxoSmithKline (GSK) Britain’s largest pharmaceutical company today announced it plans on slashing 4,000 jobs over the coming months. The bulk of the cuts will be in America and Europe, and are part of the company’s efforts to shift resources away from low-growth territories into parts of the world with greater scope to expand sales, most notably Asia. GSK’s currently employs 99,000 workers worldwide. The reduction in headcount will be combined with a drive to make the company’s research and development more cost-efficient. 

While the job losses will not be as severe as those announced last week by its rival Astra Zeneca, they will provide further depressing news for a sector that is fighting to contain costs as it reduces its reliance on big-selling blockbuster drugs, many of whose patents will expire in the next two to three years.

The pipeline of new drugs at GSK is much deeper than at many of its rivals, say industry analysts. The company’s roster of planned launches includes Menhibrix, a vaccine to combat meningitis, and Benlysta (belimumab), a novel, monoclonal antibody treatment for systemic lupus erythematosus that it is co-developing with Maryland-based, Human Genome Sciences. In total, the group has more than 30 products in the advanced stages of development and testing.

While GSK continues to develop new drugs, it has increasingly been turning to emerging markets to find and sustain corporate growth. This has meant that thousands of jobs have already been sacrificed in the West, although the company is adding staff elsewhere. For example, it recently cut 2,000 sales jobs in America but added 1,500 staff in China. Also, GSK’s vaccine division has suffered a few regulatory setbacks with its pneumococcal vaccine Synflorix and its cervical cancer vaccine Cervarix. The loss of market share in these areas has put additional financial pressure on the company.

Like many of its competitors, GSK is looking to other divisions of the company to cover projected losses in the pharmaceutical sector. Recently, GSK has shifted a lot of its attention to its consumer products division, which owns brands such as Lucozade and Ribena soft drinks, Aquafresh and Sensodyne toothpaste, and over-the-counter medicines such as Panadol painkillers and Alli, a weight-loss pill. Analysts predict the division will have raised its annual sales 18% to £4.7 billion. A deal signed last year to increase sales of Lucozade in China has provided the blueprint for how the company would like to develop the consumer healthcare side of its business.

Similarly, last week, Sanofi-Aventis, a French rival, announced a joint venture with Minsheng Pharmaceutical Group, a Chinese company, to sell vitamin pills and nutritional supplements. Also, Pfizer recently announced it would bid for the possibility of purchasing the financially-troubled German generics manufacturer Ratiopharm; signaling the possibility that the world's largest branded pharmaceutical manager may be toying with the idea of getting into the generics business.

Late last year I predicted that more pharmaceutical company employees would loss their jobs. Sadly, this prediction has come true. That said, I am surprised at the scope and size of the layoffs that have already taken place in 2010. I suspect that more layoffs are likely in the near future if the economy doesn’t turn around anytime soon.

Hat tip to Ed at the Pharmalot blog!

Until next time...

Good Luck and Good Job Hunting (try medical devices or biotech)!!!!!!!!

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More Regulatory Woes for New Antibiotic

Theravance Inc. announced Thursday US Food and Drug Administration (FDA) regulators are not satisfied with new data on its infection drug candidate telavancin (Vibativ), and indicated that further clinical studies may be required to win marketing approval.

Approval of Vibativ has been held up for three years, as the Food and Drug Administration asked the company for more data about the drug, and about studies Theravance has conducted in support of its application to the FDA. Theravance said Thursday the FDA told it the data so far is not enough to prove Vibativ works.

The agency will not begin a formal review of the drug until it says it is satisfied with the data.

Vibativ, or telavancin, is an injection intended to treat complicated or drug-resistant infections like methicillin-resistant Staphylococcus aureus (MRSA). Theravance submitted an NDA to FDA for review in December 2006.

According to Theravance, the FDA did not say Theravance would have to run a new clinical trial to gain approval, but it suggested a design for such a study. Company representative said that they do not know what the FDA wants and said the agency did not provide any suggestions about the goals of the proposed study, how many patients should be included, or even how many studies might be required ( I guess it may be time for a meeting to discuss these issues?).

In response to the FDA’s previous requests for more data on telavancin, Theravance said it combined data from two late stage trials of Vibativ, with the goal of making the data more comparable. It said the FDA told it that the data is equal to only one study. Two late-stage trials are often required to win approval.

Theravance said it has tested Vibativ on about 1,500 patients and said its studies are the largest that have been submitted in support of a new drug of its type.

Regulatory concerns about Vibativ include a risk of birth defects when it is used in pregnant women, manufacturing issues, and questions about data comparing the drug to vancomycin, which is the most powerful antibiotic currently on the market.

While getting new antibiotics are the market are important, clinical studies must be carefully designed with appropriate endpoint to address potential safety and efficacy issues. Although Theravance believes that it has done that, the agency, as always, will be the final arbiter of a decision on telavancin.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

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Is the Economy Really Improving? Astra Zeneca to Cut 8,000 Jobs

AstraZeneca PLC said today it , or 12 percent of its work force, by 2014 to cut costs as it reported disappointing fourth quarter earnings. The job cuts will be made across all regions and divisions and were necessary because some of the company’s major products including the child asthma medication Pulmicort, which made sales of $1.3 billion in 2009, and breast cancer treatment Arimidex, with $1.92 billion in sales will be losing patent protection in the near future.

CEO David Brennan said the company was extending a cost-cutting program it launched in 2007, which had saved the company $1.6 billion annually at the end of 2009.Extending the program out to 2014 will cost another $2 billion, with expected benefits of $1.9 billion a year by 2014, he said.

Around 12,600 jobs having already been eliminated under the program, although Brennan suggested that the net figure was closer to 4,600 after new roles were created by the company, which employs around 63,000 people worldwide.

The new round of cuts will be global, including sales and marketing, business infrastructure, research and development and the supply chain. The company’s research & development division will lose about 1,800 jobs and according to Brennan there may be some closures of research and development sites or facilities as part of the restructuring. The company is reported to be waiting for regulatory approval of five new products.

Despite claims that the US economy is improving, big pharma continues to downsize its R&D workforce. Call me crazy, but aren’t these the same companies that argue that healthcare reform will stifle innovation and hinder new drug discovery? This begs the question: how do you discover new and novel medicines and treatments if the people who discover and develop drugs no longer work at your company? There is always outsourcing and M&A I suppose.

Until next time...

Good Luck and Good Job Hunting

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Merger Aftermath: Pfizer Refocuses

While I never was involved in a corporate acquisition or merger, I have many friends who have lived through them and based on their experiences it is a never a “pretty sight.” Merger aftermaths usually feature massive layoffs, executive management disputes and turf wars and corporate culture clashes tha occur when two workforces are forced to merge as one. However, sometimes mergers may be a good thing for struggling companies. To that end, Pfizer may actually benefit from it $68 billion acquisition of Wyeth late last year.

The acquisition will cost at least 20,000 employees their jobs—not a good thing in a national economy where unemployment is well over 10 percent (despite claims to the contrary). However, this merger is strikingly different than Pfizer’s questionable past mergers and acquisitions which were primarily engineered to procure one or two drugs that had blockbuster potential e.g. Lipitor and Celebrex. This time around, Pfizer’s management team is actually re-evaluating its entire drug development portfolio and attempting to expand the company’s pipeline to include vaccines, therapeutic proteins and other biologics. As I previously noted, most major pharmaceutical companies believe that biologics will be the major driver of pharmaceutical markets in the not so distant future.

According to a post on PharmaLive, Pfizer announced that it will discontinue research and development on roughly 100 experimental new drug candidates. Pfizer officials revealed that the company will continue with 500 research projects in six areas of: 1) Alzheimer’s disease, 2) diabetes, 3) pain, 4) cancer and 5) mental illness (including schizophrenia).

Of the 500 projects, 30 drugs are being tested for cancer indications, 10 for Alzheimer’s disease, eight for pain and 11 for inflammation. Further,133 are in various stages of human clinical testing, including several that are awaiting regulatory approval in the US and elsewhere. 

On the biologics front, Pfizer has six vaccines and 27 biopharmaceutical drugs in development. Prior to the Wyeth acquisition, the company only had one vaccine and 16 new biologics that it was testing. Like most other pharmaceutical companies, Pfizer wants to be a major player in the biopharmaceutical and biologics markets by 2015.

Only time will tell!

Until next time,

Good Luck and Good Job Hunting!!!!!!!

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Shuffling of Executives at Novartis: Vasella is Out as CEO

The Pharmalot blog authored by the intrepid Ed Silverman today reported that Dan Vasella is out as CEO at Novartis and there has been an executive shake up at the company. According to the post, Vasella is reliquishing his post a CEO but retaining his chairman title For a complete run down and a glimpse at the new Novartis org chart read Ed's post

Vasella has come under fire (literally and figuratively) over the past year or so.  Industry insiders and Novartis shareholders contended that he couldn't manage the day-to-day operations of companies and succeed as Chairman. Also, Vasella was the victim of  unwarranted, vicious attacks by animal rights activists who publicly denounced him and set his home on fire!

Vasella, one of the few physicians to head a pharmaceutical company, held the top position since 1996 following the merger of Sandoz and Ciba-Geigy to form Novartis. The company has expanded in to new therapeutic areas and markets and performed well under Vasella's stewardship. However, many industry experts contend that ten years is the optimum tenure for most life sciences CEOs. What's four years in the scheme of things?

Until next time....

 Good Luck and Good Job Hunting!!!!!!!

A Common Thread: Pompe Disease, Genzyme and Hollywood

Harrison Ford’s new movie “Extraordinary Measures” (also starring Brendan Fraser) is loosely based on John Crowley’s ongoing crusade to find a cure for Pompe Disease a genetically inherited illness that afflicts two of his three children.The film chronicles the 'extraordinary measures' taken by Crowley to find a treatment for the so-called orphan disease that affects the lives of about 40,000 persons worldwide. While I haven’t seen the film, it bears a striking resemble to the 1992 film “Lorenzo’s Oil” which chronicled the struggles of two parents to find a “cure” for their son’s adrenoleukodystrophy an another orphan disease.

Crowley’s story began about 12 years ago when his oldest child was diagnosed with Pompe Disease. For those of you who may not know, Pompe Disease is a progressive, multisystemic, debilitating, and often fatal neuromuscular disorder. The disease is linked to an inherited deficiency of the lysosomal enzyme acid alpha-glucosidase (GAA), which is responsible for the breakdown of glycogen inside the cells. The result is intralysosomal accumulation of glycogen, primarily in muscle cells, that leads to a progressive loss of muscle function and ultimately death. At the time of the diagnosis, Crowley, a Princeton, NJ resident, was working as a marketer for Bristol Myers Squibb. He quickly learned that there was no effective treatment for Pompe Disease and that his daughter may not live beyond early childhood. Further, because the disease afflicted so few individuals, no pharmaceutical or biotechnology companies were working on treatments for Pompe Disease. 

To stave off the likelihood of his daughter’s death, in 2000, Crowley raided his 401k plan and mortgaged his home to start a company called Novazyme that focused exclusively on developing treatments for Pompe Disease. Having no time to waste, Crowley and the Novazyme team worked feverishly to develop an alglucosidase alfa enzyme replacement therapy for Pompe. By 2001, the Novazyme team had identified a likely treatment and Crowley sold his company to Genzyme. As a senior vice president at Genzyme, he oversaw clinical development of the product which is now called Myozyme and is the first FDA-approved treatment for Pompe Disease. Crowley left Genzyme in 2004 and is currently CEO of Amicus Therapeutics a 100 person company focused on developing new treatments for Pompe Disease and other orphan indications.

At present, there are no other treatments besides Myozyme for Pompe Disease. This is because Pompe Disease is designated as an orphan indication and Genzyme received seven years of market exclusivity for Myozyme as stipulated in the Orphan Drug Act. Myozyme received FDA approval in 2006.

While Genzyme has been the only player in the Pompe Disease market for the past four years, manufacturing and scale up problems threaten to jeopardize the Myozyme franchise. Genzyme’s highly publicized problems at its Allston, MA-manufacturing facility have been well documented and Genzyme’s management team is taking bold steps to correct them (including hiring a new senior vice president for global product quality) and entering into an agreement with Hospira Worldwide Inc to provide fill and finish manufacturing services.

But perhaps more troubling, were the problems that the company experienced when attempting to scale up Myozyme production from the 160L to 200L bioreactor scale to meet growing demand for the drug.  FDA informed Genzyme that that Myozyme® (alglucosidase alfa) produced at the 160L bioreactor scale and Myozyme produced at the 2000L scale should be classified as two different products because of differences in the carbohydrate structures of the molecules. And, the company would have to file a new biologics application (BLA) for the 2000L product to garner regulatory approval.

Currently, Genzyme has U.S. approval to sell Myozyme manufactured at the 160L scale, and the company has been seeking clearance from the FDA for Myozyme produced at the 2000L scale (now marketed as Lumizyme). Lumizyme has already been approved in more than 40 countries. However, manufacturing problems and violations at the Allston facility forced FDA to delay a decision on the approvability of Lumizyme this past March. Earlier this week, Genzyme announced that FDA will issue a new decision on Lumizyme in June.

While originally spurned by large drug companies, orphan drug development is becoming much more attractive because of the lack of new blockbuster drugs in most company’s development pipeline. According to a recent report, the number of orphan product designations in the US more than doubled in the last decade rising from 208 in the 2000-02 periods to 425 in 2006-08. More recently, Pfizer, the world’s largest pharmaceutical company announced that it agreed to pay at least $60 million for rights to Protalix Biotherapeutics Inc.'s new treatment (taliglucerase alfa) for Gaucher’s Disease another orphan indication. This suggests that Pfizer has made a decision to directly compete with Genzyme, the world leader in orphan drug development.

Don’t be surprised when other large pharmaceutical and biotechnology companies announce plans to compete in the orphan drug market...there is money to be made!

Until next time...

Good Luck and Good Job Hunting!!!

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Issues Surrounding the Use of Social Media in the Life Sciences Industry are Still Alive and Well

Despite rumors of impending demise and premature death, the issues surrounding the use of social media in the life sciences industry are still alive and relevant. To that end, the Business Development Institute is sponsoring a “Healthcare Social Communications Leadership Forum Breakfasts on February 4, 2010 at New York University in Manhattan. The conference is limited to 75 attendees. While there are seats still available they are rapidly disappearing. 

Some of the topics to be discussed include:

  • How to connect with consumers who are already using the internet for healthcare information?
  • What are the case studies of leading brands that use internet based social strategies to achieve communications objectives?
  • What are examples of social communities that demonstrate how leading healthcare brands interact, educate and provide value to consumers online?
  • How to deal with regulatory and legal issues when planning and implementing social and internet based strategies
  • Why real-time social media tools, such as Twitter, are gaining momentum and what's the business case to use them
  • How to sell projects and prove ROI to senior management
  • What are the tools, technologies, and best practices for monitoring and measuring internet based programs?

Scheduled presenters and panelists are:

  1. Michael Fleming, Senior Director, Social Media, GlaxoSmithKline
  2. Robert Halper, Director of Video Communication, Johnson & Johnson
  3. Lance Hill, CEO, Within3
  4. Ray Kerins, Vice President / Worldwide Communications, Pfizer Inc.
  5. Marc Monseau, Director, Corporate Communications & Social Media, Johnson & Johnson
  6. Rodney Spady, Head of Global Interactive Marketing and Web Officer, OTC Global Marketing, Novartis Consumer Health, Inc.

For more information, including registration, please click here to visit the event website. Use promo code BIOC before February 3rd for a discounted rate of $175.

See you at the meeting!

Until next time...

Good Luck and Good Job Social Networking!!!!!!

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Is Pfizer Positioning Itself to Enter the Generic Pharmaceuticals Market?

Pfizer is one of three companies vying for the opportunity to . Teva Pharmaceutical Industries Ltd, the Swedish private equity fund EQT and Pfizer are the three finalists to purchase Ratiopharm GmbH which is valued at about €2.8-3 billion. The finalists will make their bids in early February. France’s Sanofi-Aventis SA Euronext and China’s Sinopharm Group Co. Ltd. withdrew from the tender in December

Ratiopharm is a private company owned by the Merckle family. Ludwig Merckle put the company up for sale last year, after his late father Adolf Merckle committed suicide in early 2009 after losing control over his business empire to lenders. If Teva acquires Ratiopharm, it will win a major foothold in the German healthcare market, considered a large and growing market. Teva, the world’s largest generic drug company, is currently not a big player in the German market.

 The rising development and retail costs of name brand prescription drugs and the future possibility of price controls in the US is forcing pharmaceutical companies to reconsider the value of generic drugs. Currently, generic prescriptions are rapidly outpacing those for branded products and the size of the US and international markets for both small and large molecule drugs (biosimilars) growing daily. Previously, most innovator companies didn’t think the profit margins nor returns on investment were sufficient to add generic molecules to their product portfolios. However, a few large pharmaceutical companies have already entered the generics fracas; most notably Sandoz (a division of Novartis) which manufactures both generic small molecule and biosimilar biotechnology products and more recently established Merck BioVentures which aims to compete in the follow-on biologics market. 

Many experts believe that it is only a mater of time before most big pharma companies like Pfizer realize that they have to be in both the branded and generic sides of the business. Don’t be surprised over the coming months if other pharma companies consider doing deals to acquire generic drug manufacturers. Diversification will be the mantra of the next decade or so!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!

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Does Direct-to-Consumer Television Advertising Really Work?--You Betcha!

Last week, the market-analyst firm Manhattan Research released a list of the top branded pharma Web sites based on traffic generated from direct-to-consumer (DTC) television ads. The firm tracked about 250 different product sites and asked 6,575 consumers which websites they visited in the past 12 months. Consumers were asked to recall the reason they visited the site, whether they are taking the product, think they need the product, and the actions they took after they visited the site. The following list represents the top ten product websites that were more likely to have website traffic driven by DTC television ads. However, it is important to note that the rankings are not based on the volume of traffic but the percentage of traffic generated in response to integrated DTC advertising campaigns.  

  1. NuvaRing—Merck (formerly Schering Plough formerly Organon)
  2. Latisse—Allergan
  3. Cialis—Lilly
  4. Boniva—Roche
  5. Abilify—Bristol Myers Squibb
  6. Gardasil—Merck
  7. Yaz— Bayer
  8. Viagra—Pfizer
  9. Levitra—Eli Lilly
  10. Lunesta—Sepracor

Interestingly, of the top ten products on the list about 70% of them have to do with sex or woen's reproductive health. The exceptions include Abilify (depression and bipolar disease), Lunesta (insomnia) and Latisse (eyelash growth). Pfizer, Levitra and Cialis are treatments for ED, Gardasil is an anti-cervical cancer vaccine, Boniva is used to treat osteoporosis (post menopausal women) whereas Yaz and NuvaRing are both used for birth control.

I thought the results of the survey where interesting because many experts say the effectiveness of DTC television advertising may be waning with the growing use of online resources. While the results of this survey are not conclusive, it suggests that DTC television advertising won’t be going away anytime soon. And that the growing use of televisions as web portals may actually increase not diminish industry’s reliance on DTC television ads to sell its product and treatments—oy! 

Hat tip to George Koroneos at the PharmaExec.com blog.

Until next time...

Good Luck and Good Watching!!!!!!!!!

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The Saga Continues: Will Genzyme Soon Be Up for Sale?

While Genzyme has begun to address its manufacturing woes and its CEO and top leadership have managed to keep their jobs, the specter of a possible forced sale of the company has emerged. This is because Carl Icahn, the billionaire, activist investor with a history of forcing the sale of financially-challenged and underperforming public biopharmaceutical companies like ImClone and MedImmune, owns 1 percent of the outstanding shares of Genzyme.

Speculation is rife that Icahn and Ralph Whitworth, a founder of Relational Investors which owns 4 percent of Genzyme’s stock, may force the company to put itself up for sale. While many experts contend that this may not be in the best financial interests of Icahn and Whitworth (or other institutional investors), the threat may allow both men to get themselves or their representatives on Genzyme’s board. This would allow them to control the direction of the company and better position the company (the fifth largest biotechnology company in the world) for future sale. Henri Termeer, Genzyme’s embattle CEO, said he has had no contact with Icahn.

Investors have not been pleased with Genzyme’s current management team’s decision to plow profits from its orphan disease business into R&D activities that have been unsuccessful. According to a recent Citigroup financial report, the company may have squandered over $1.0 billion (throughout its history) by investing into unprofitable, non-core research areas including kidney disease diagnostics and surgical products. Conventional wisdom suggests that if Icahn and Whitworth gain control of the Genzyme board that they could sell off Genzyme’s unprofitable kidney disease and surgical lines which would allow management to focus on orphan diseases drug development and allow the company to fix its recent highly publicized manufacturing problems.  Relational’s Whitworth hinted that this is one scenario that he may be interested in pursuing. To date, Icahn has been uncharacteristically mute on a possible takeover attempt.

Stayed tuned for more details.

Until next time....

Good Luck and Good Job Hunting!!!!!! (try Genzyme, they are probably looking for a few good biomanufacturing executives and managers)  

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Healthcare Reform: Obama Pushes for Shorter Data Exclusivity Period for Biosimilars

Many progressives and left-leaning individuals (like me) voted for President Obama because he presented himself as somebody who will stand up for what he believes. Until recently, I, along with others, have been deeply disappointed in his performance and it was no longer clear to me what he truly believes in. However, his recent stand on healthcare reform (sadly without a public option), his performance at the global warming summit and most recently his quick response and unequivocal support for Haitian earthquake victims suggest to me that we are finally beginning to see what President Obama believes and what he is made up. To that end, Obama has turned up the heat to reduce the proposed 12 period of data exclusivity for biosimilars (aka follow-on biologics) in the bill that was passed by both the US House and Senate. Both the President and Rep. Henry Waxman, D-CA (of Hatch-Waxman fame) are trying to reduce the 12 year exclusivity 10 years or less. Obama previously went on record saying that he favored a 7 year exclusivity period for biosimilars.

Not surprisingly, the move has met with fierce opposition from the pharmaceutical and biotechnology industries that argue the longer period is needed to encourage investment and R&D required to produce biopharmaceutical products. Lobbying by both sides has dramatically increased as healthcare reform is pretty much a done deal. However, brand companies have spent many millions more than generic manufacturers to lobby Congress on the 12 year period.

It is about time that an American President is willing to do what is in the best interest of the American public instead of what lobbyists and special interests are demanding. And, to those companies that steadfastly hold to the notion that biopharmaceuticals take an inordinately long time to bring to market I ask: “What’s in your pipeline?”

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!!!

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Bioscientists and the MBA Degree

I am frequently asked by graduate students and postdoctoral fellows who are having trouble finding a research and development job, whether or not it makes sense to go to business school to get an Masters of Business Administration) MBA degree to enhance their business acumen. While I don’t think it would hurt (especially if you are interested in business), I also don’t think most scientists benefit from enrolling traditional MBA degree programs. With this in mind, some forward-looking academic institutions have launched joint PhD-MBA programs which allow students enrolled in these programs to graduate with PhD and MBA degrees at the end of their graduate training.

The joint programs typically take less time than it would to earn each of the degrees individually and mainly cater to scientists who have decided to eschew academic science careers in favor of life sciences management jobs. While these programs are relatively new and continue to evolve, growing numbers of would-be scientists who are also interested in business are taking advantage of them.

One of these students, Kristy Houck graduated with a PhD in pharmacology and a MBA from the Pennsylvania State College of Medicine joint program almost two years ago. “I loved science, but knew that I didn’t want to perform bench work for the rest of my life. This opened a world of career opportunities for me” said Houck. “Previous graduates of the program have quickly risen to management level positions because they are recognized as business-savvy scientists” she added.

Other academic institutions are closely watching these programs to determine whether or not graduates of the joint PhD-MBA programs have better employment outcomes as compared with person who go through traditional PhD and MBA graduate programs. I listed the institutions that currently offer the joint program in the table below. Check it out!

Academic institutions that offer joint PhD/MBA program in the life sciences

 

Name of Institution                                                   Website

Dartmouth

http://su.pr/2udGyO

Pennsylvania State University (Dept. of Pharmacology)

http://su.pr/21CRWm

San Diego State University

http://su.pr/2hqX8y

University of Connecticut

http://su.pr/4LQ6Dt

University of Florida

http://su.pr/2ltSSj

Vanderbilt University

http://su.pr/9Ze6Uf

Wake Forest University

http://su.pr/As4gip

Until next time....

Good Luck and Good Job Hunting!!!!!!

 

Happy New Year: Merck and Pfizer Announce 900 Job Cuts

Just when you thought things couldn’t get much worse for New Jersey, Merck and Pfizer today disclosed that it will eliminate 900 more jobs in NJ. While the job cuts were expected, it is still bad news for New Jersey’s life sciences workforce.

Based on information provided by the New Jersey Department of Labor website Pfizer will eliminate 400 jobs from Monmouth Junction, NJ where Wyeth previously maintained research offices. Similarly, Merck plans on cutting 500 jobs in Kenilworth, NJ where Schering Plough’s maintained its former headquarters. While it isn’t clear what types of jobs will be affected, cuts are expected in both R&D and sales continuing an ongoing trend that began almost three years ago. In case you haven’t been paying attention, most major American pharmaceutical companies have been eliminating R&D jobs in the US and either outsourcing those activities or building new research facilities in India, China, Brazil and Eastern Europe where there are lost cost, highly trained pharmaceutical scientists.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

 

Genzyme Announces It Will Outsource Fill and Finish Operations for Cerezyme, Fabrazyme, Myozyme and Thyrogen

Genzyme announced in a Securities and Exchange Commission filing on Monday that it inked a "fill and finish manufacturing services" deal with Hospira for several of its top selling drugs including Cerezyme (Gaucher disease), Fabrazyme (Fabry disease, Myozyme (Pompe disease) and Thyrogen (thryroid cancer). The move follows a series of highly publicized manufacturing problems at the company’s Allston Landing, MA biomanufacturing facility in 2009.

Beginning in March, Genzyme received a warning letter from the US Food and Drug Administration (FDA) detailing "significant objectionable conditions" at the Allston facility. The agency identified deviation and violations of current Good Manufacturing Practice (GMP) in four areas including: 1) maintenance of equipment, 2) computerized systems, 3) production controls and 4) the failure to follow procedures aimed at preventing microbiological contamination.

In June, Genzyme shut down the biomanufacturing plant to clean up viral contamination that had been slowing down production of Cerezyme and Fabrazyme. The virus, Vesivirus 2117, is known to interfere with the growth of Chinese hamster ovary (CHO) cells and is believed to have been introduced through a cell culture nutrient. The virus doesn’t infect humans, but the shutdown cost the company millions in revenue and caused shortages of Cerezyme and Fabrazyme. Production restarted at the plant in September.

Meanwhile, in November, the Food and Drug Administration said it found tiny particles of steel, rubber and fiber in finished vials of Cerezyme, Fabrazyme, Myozyme, Aldurazyme (mucopolysaccharidosis I) and Thyrogen. These and other violations are outlined in a 483 that was issued by FDA following inspection of the troubled facility.

The deal with Hospira, which makes drug and medication delivery systems,calls for the initial term to expire on Dec. 31, 2015. There are options for a two-year extension. The financial terms of the agreement were not disclosed. The deal is still subject to regulatory approval for manufacturing the products.

While GMP deviations and warning letters are common place at many biotechnology companies, Genzyme’s ongoing manufacturing problems had potentially grave medical implications. This is because, unlike most of its competitors, Genzyme focuses almost exclusively on the development of orphan drugs. Orphan drugs are used to treat diseases like Gaucher, Fabry and Pompe disease which are rare, afflict relatively small numbers of patient and usually result from genetic mutations. Generally speaking, there is usually only a single manufacturer of orphan drugs. Consequently, manufacturing problems can result in drug shortages which may inhibit access to these life saving drugs. As corny as it may sound, patients with orphan diseases have literally placed their lives in the hands of the drug companies that manufacture these orphan drugs.

Until last year, Genzyme had an outstanding and impeccable reputation and was regularly lauded by the orphan drug community. Unfortunately, its management team lost sight of its original to commitment to quality—a sign that changes may be necessary in the executive suite. Hopefully, the new fill and finish deal with Hospira will eliminate many of the company’s manufacturing problems and Genzyme can restore confidence in its brand!

Until next time....

Good Luck and Good Manufacturing !!!

 

Novartis Offers $38.5 Billion to Purchase Alcon and Position Itself as a World Leader in the Eye Care Market

Novartis AG today announced it plans to take over Alcon Inc. by paying $38.5 billion for the 77 percent stake it does not already own in a deal that would make it one of the biggest players in the global market for eye-care products.

The Swiss pharmaceutical and generics giant had already purchased 25 percent of Alcon from Nestle in April 2008 for $11 billion, with the option of buying the food and drinks company's remaining stake at a later date. With the acquisition of Alcon, Novartis will control about 70% of the world’s vision market (it already owns the Ciba Vision brand). Alcon is based in Huenenberg, Switzerland, and has its U.S. headquarters in Fort Worth, Texas. The company employs some 15,000 people worldwide and specializes in surgical equipment and devices, contacts lens solutions and other consumer eye-care products.

Daniel Vasella, MD, Novartis’ Chairman and CEO, said "This is the right time to simplify Alcon's ownership to eliminate uncertainties for employees and shareholders." He added "It will also allow us to strengthen innovation power by combining R&D efforts and grow our global market presence thanks to our complementary product portfolios."

If I were a betting man, I would say that Novartis is the pharmaceutical company to watch over the next decade. Like Johnson and Johnson, the company has diversified its business to include consumer goods, vaccines and perhaps most importantly generic pharmaceuticals via its Sandoz division. One area that Novartis hasn’t fully embraced to date is devices. However, as we enter the age of personalized medicine, don’t be surprised if the company acquires or invests in a variety of medical devices and diagnostic companies!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

 

Johnson and Johnson's Antibiotic Ceftobiprole Hits Another Regulatory Snag

Johnson & Johnson today announced it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) for ceftobiprole. The agency requested additional information and recommended additional clinical studies be conducted in order to consider a future approval of ceftobiprole in this indication. J&J’s New Drug Application (NDA) for ceftobiprole was originally submitted to the FDA in May 2007 for the treatment of complicated skin and skin structure infections (cSSSI), including diabetic foot infections.  The company received an approvable letter in March 2008 and submitted what it thought to be the necessary information necessary to garner approval of the new antibiotic

Ceftobiprole is a novel, broad-spectrum, anti-MRSA cephalosporin with activity against methicillin-resistant Staphylococcus aureus (MRSA), penicillin-resistant Streptococcus pneumonia and many clinically important Gram-negative bacteria, including Pseudomonas. The antibiotic was licensed from Swiss-based Basilea Pharmaceutica Ltd. in February 2005. 

The regulatory review process is ongoing in Europe and other countries for the use of ceftobiprole in adults for the treatment of complicated skin and skin structure infections. Ceftobiprole is approved in Canada, Switzerland, Russia, Azerbaijan, Ukraine and Hong Kong.

J&J intends to discuss the best path forward with the FDA as soon as possible. New antibiotics are necessary to combat the growing trend of multiple drug resistant strains of bacteria that are responsible for an increasing amount of bacterial infections.

Until next time...

Good Luck and Good Job Hunting!!!!

 

Merck Acquires Contract Manufacturer Avecia as it Positions Itself to Enter the Follow on Biologics Market

Merck & Co. Inc., and Avecia Investments Limited today announced that they have entered into a definitive agreement by which Merck will acquire the biologics business of UK-based Avecia; a contract manufacturing organization with specific expertise in microbial-derived biologics. A Merck executive commented on the deal:

"At Merck we continue to execute on our strategy of expanding our biopharmaceutical expertise and manufacturing capacity, This transaction follows an initial strategic development and supply relationship with Avecia Biologics and will provide us with an operational facility staffed by an experienced workforce that is highly skilled in a broad portfolio of bioprocess systems."

The Avecia acquisition follows Merck’s announcement late last year that the company will enter the global follow-on biologics (aka biosimilar) market. Merck’s decision was likely based on strategic acquisitions several years ago of a small biotech company, Glycofi, which developed a humanized yeast protein production platform, and Insmed, a Richmond, VA-based, follow-on biologics company, which was acquired last summer. Avecia provides Merck with the biomanufacturing capacity and expertise that it will need for clinical development and commercial manufacturing of its follow-on biologics. The company expects to bring its biosimilar products to market by 2017 or earlier.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

 

Viagra: "The Next Generation"

Pfizer was the first to bring us ED (erectile dysfunction) and now two companies—one large (Johnson and Johnson) and one small (Sciele Pharma)—are daring to boldly go where no MAN has gone before: to conquer PE aka premature ejaculation!

According to a brilliantly-crafted story by Natasha Singer published in this Sunday’s New York Times business section, JnJ developed a pill called Priligy which is intended for men who ejaculate before intercourse or within a few seconds after beginning. Priligy which is intended to help to prolong latency before orgasm is approved and sold in nine countries but hasn’t been approved for sale in the US. On the other hand (so to speak), little known, Atlanta, GA-based Sciele Pharma is planning to seek regulatory approval for a prescription aerosol-based product that is sprayed on the skin (in this case the penis) to prolong latency and forestall ejaculation. While the true incidence of PE is uncertain, the manufacturers of these medications want men (and women) to believe that the condition is more pervasive and prevalent than reported. 

Interestingly, the worldwide sales of Pfizer’s Viagra were approximately $1.93 billion last year. As previously noted on BioJobBlog, Viagra celebrated its 10th anniversary of marketing approval last March. If you do the math, almost $20 billion dollars worth of Viagra prescriptions were written over the past decade. This suggests that many millions of men must suffer from ED worldwide. However, for those of you who may not know, Viagra also works quite well for healthy, sexually active males who don’t suffer from ED. It is generally acknowledged that it is this segment of the male population that is responsible for the annual blockbuster sales of Viagra and related medications. Also, it is important to note that prior to the introduction of Viagra, ED wasn’t a recognized clinical indication (it was known as impotence) and there were very effective treatments for it. And while ED is a legitimate quality-of-life issue, it occurs in only a small percentage of sexually active males; mostly in older men with hypertension, cardiovascular conditions or those who have had their prostates removed.

Viagra, like Botox, Latisse and others, is classified as a so-called “lifestyle” drugs. Generally speaking, lifestyle drugs are developed to improve the quality of life of patients not treat potentially life threatening diseases or conditions. In her article, Ms. Singer takes the pharmaceutical industry to task about the development of  blockbuster lifestyle drugs.

“But creating a blockbuster quality-of-life drug like Viagra involves more than just being innovative or being first. Sometimes it requires a drug maker to create and market a whole new category of disease.

The template goes something like this: Start with a legitimate quality-of-life issue — like fitful sleep or shyness — that does not yet have its own prescription medication and is debilitating to a few people a lot of the time. Next, position the quality-of-life issue as a medical condition with symptoms so common it covers vast numbers of people who had previously not identified themselves as having a health problem, or who thought they were just experiencing an occasional and normal annoyance.

Articles in medical journals with high estimates on the prevalence of the issue help convince doctors and journalists of its scope. F.D.A. approval of the new drug legitimizes the condition as a problem with a medical solution.

While there is no doubt that some men are distressed about their inability to control their orgasms, there is little concrete evidence to suggest that there is an epidemic of premature ejaculation”

Although I have never used Viagra, I have a few “older male friends” who swear by it! And, while I have no doubt that Viagra and the new medications being developed to treat PE may benefit a few men, is it appropriate to elevate premature ejaculation to a bona fide clinical indication and spend billions to develop and market treatments for it? Don’t get me wrong; I am not trying to minimize the emotional distress and discomfort associated with PE. But, the last time I checked, PE didn’t make the top ten lists of the world’s most devastating and debilitating clinical indications or unmet medical needs!

Until next time...

Good Luck and Good Job Hunting!!!!

 

Signs of an Economic Recovery? Spending on Direct-to-Consumer Advertising is on the Rise Again

A post on the Pharmalot blog today reports that spending on direct-to-consumer pharmaceutical advertising came bounding back in the third quarter —rising 15 percent to $1.16 billion, according to DTC Perspectives (which cited data from TNS Media Intelligence).

The increased spending marks the first quarterly gain in nearly two years after slumping 6.4 percent earlier this year from January to June. According to the Pharmalot post, “Internet spending increased the most—more than tripling between January and September to $221 million (display ads only). And, more ads were placed in newspapers, which showed a 25 percent gain to $104 million during the same period.

During the first nine months of 2009 the leading advertisers by brand (each of which spent more than $125 million each) were:

  1. Lipitor (Pfizer)
  2. Abilify (Bristol-Myers Squibb/Otsuka America)
  3. Cymbalta (Eli Lilly) and
  4. Advair (GlaxoSmithKline)

Could this be a sign that the pharmaceutical industry thinks that the economy is improving? Alternatively, maybe pharma marketers think that people might become increasingly stressed by the economy and drugs like Abilify and Cymbalta (a variety of psychiatric indications) and Lipitor (high blood pressure, cardiovascular disease ands stroke) may be in greater demand. And finally, from a completely cynical perspective, maybe drug makers want to sell as many drugs as possible before healthcare reform and possible price controls kick in?

Hat tip to Ed!!!!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!

 

From the Are You Kidding Me Files: Pharm Giant Sales Force Goes Green With High Fashion Handbags

As a blogger I get on average 2-3 press releases per day from publicists who want me to pick up their releases and publish them on BioJobBlog. I usually pass. But, the one that I received from a publicist who represents eco-friendly and politically-correct Red Handed Bags was too good not to share with my readers (see below)

Pharm giant sales force goes green with high fashion handbags

Raleigh NC-based fashion designers Aaron Turney and Tracy Russomano are used to working with fashion conscious women.  But this year, they devoted their special talents efforts to addressing the special needs of a unique group of highly specialized handbag users – pharmaceutical sales reps.

GlaxoSmithKline asked them to design an environmentally friendly work bag specifically for their pharmaceutical sales reps to use on the job.

Redhanded Bags has created a line of beautiful handbags using green technologies, animal free materials, and sweat free manufacturing facilities and workforces. 

“It’s pretty admirable that they’ve set themselves a goal for using handbags that don’t hurt animals, don’t pollute the environment and don’t exploit anyone,” said Tracy Russomano. “We worked directly with the sales people to design the ideal pharm sales rep bag. When we were done, GSKs onsite ergonomist gives the bags an excellent rating for ergonomic design.”  

“Handbags should turn heads, bring out inner beauty, and contribute to a sustainable environment,” said Ms. Russomano. “Pharmaceutical sales reps can look great  and be eco-friendly.”  I am partial to the middle bag; which one is your fav?

I find it admirable that GSK is thinking environmentally. However, are several thousand eco-friendly handbags for sales reps really going to make a difference? I think it would behoove GSK and other drug makers to invest in developing green manufacturing technologies and facilities if they are truly concerned about reducing the size of their carbon foot prints. 

After visiting the Red Handed bags website, I agree with Ms Russomano, that pharma reps (who still have jobs)  will look great and turn some head while sporting the new bags (exactly what GSK wants). That said, it is extremely gratifying to know that the environment is safe, no animals were killed and no workers were exploited to help sales reps sell drugs to their customers!

Until next time...

Good Luck and Good Shopping (check out the handcuff clutch)

 

Another Pharmaceutical Company Settles Illegal Marketing and Promotion Lawsuits

The New York Times reported today that AstraZeneca has agreed to pay $520 million to settle two federal investigations and two whistle blower lawsuits over the sale, marketing and off-label promotion of its blockbuster antipsychotic drug Seroquel. Despite this settlement, UK-based AstraZeneca still must contend with 14,444 civil lawsuits filed by many patients who developed diabetes and other health related conditions because of misleading marketing that failed to adequately disclose that the drug caused abnormal weight gain.                     

AstraZeneca joins a growing list of pharmaceutical companies that have been penalized for off label promotion and misleading advertising. Earlier this year Eli Lilly & Co paid $1.4 billion over its marketing of another antipsychotic drug Zyprexa and Pfizer announced that it would pay $2.3 billion including a record-breaking criminal fine of $1.195 billion mostly for its painkiller Bextra which was withdrawn from the market.

Despite the size of the fines and settlement figures for these recent cases, they are a drop in the bucket when compared with the amount of money generated by illicit marketing and advertising. For example, the $520 million that AstraZeneca has agreed to pay to settle the Seroquel case pales in comparison to the $17 billion that the drug has generated in US sales since 2004. The same was true for Zyprexa and Bextra.

While these settlements cannot repair much of the damage that has been done to unknowing patients, it signals that the US government is beginning to live up to its pledge to provide safe and efficacious medicines to the American public.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!!

 

The Inside Track: M&A is Not the Way to Reinvigorate R&D

I received a call today from GDS International, a UK-based b2b publishing company, alerting me to its annual, event called the Next Generation Pharmaceutical Summit (NGP) currently taking place at the Ritz Carlton on Amelia Island in FL. This invitation only event is supposed to bring pharmaceutical and life sciences executives to discuss problems facing the industry and what thing ought to be implemented to insure continued progress and growth.   This is the news coming out of the conference attended by over 50 pharmaceutical and biotechnology executives

Big Pharma concludes that M&A is not the New R&D

With large firms seeking synergies to drive down R&D costs, M&A deals can aid in the transfer of technical knowledge, scalability and reduce time to market. However, previous M&A periods have not alleviated the productivity crisis. “While short term gains emerge from these deals, in the mid to long term, R&D innovation, organic growth, and internal drivers are still key facet’s behind creating a successful company and providing an organization with sustainability.” So says, an executive committee composed of  50 pharmaceutical executives including Jeffery Nye, Chief Medical Officer at Johnson & Johnson, Reinilde Heyrman—VP of Clinical  Development at Daiichi Sankyo, Oscar Laskin—VP of Early Development at Celgene are leading the debate, joined by Ann Wang—VP of Clinical Operations at Human Genome Sciences. These sentiments confirm the notion that the pharmaceutical and biotechnology industries are in transition and suggest that life sciences companies still face many serious challenges in the not too distant future.

While increasing mergers and acquisitions isn’t likely to reinvigorate R&D, newly emerging economic pressures have recently triggered another wave of M&A activity in both sectors. But is this the solution for long-term sustainable growth?  “The willingness for the industry to unite in such a way clearly demonstrates long-term strategies for improved business processes so long-term investment in R&D can be secured” said Drew Contessa the NPG director.

The NPG will reconvene in April 2010 to review recommendations and actionable items.

The realization that M&A is not a solution to correct waning productivity in R&D was a long time coming. It cost about 150,000 pharmaceutical employees their jobs over the past three years. The idea that companies are beginning to recognize that buying or merging with another company is not a panacea or long term fix is a good thing. 

Hopefully, the life sciences industry can learn from its past mistakes.

Until next time....

Good Luck and Good Job Hunting!!!!!! 

The Future: DNA Identify Theft?

Advances made in DNA sequencing technology and genomic analysis has lowered the cost of sequencing a genome from millions of dollars a decade ago to less than $500 today. And, because of this, there are a growing number of companies that are willing to quickly and cheaply sequence and analyze your DNA. While this may be medically beneficial and appealing to some, it may not be for everyone. Moreover, and perhaps more importantly, who will control access to and insure the privacy of your genetic information if you choose to have your genome sequenced and analyzed. 

Alan McHughen, PhD, a molecular biologist and Professor of Botany and Plant Sciences at the University of California-Riverside, who has previously written about privacy and access to personal genomic data, wrote an article for BioJobBlog that explores the ramifications and possibility of DNA identity theft in the future. Also, he has written a book 'Pandora's Picnic Basket; The Potential and Hazards of Genetically Modified Foods' to refute the myths and explore the genuine risks of genetic modification technology

Genetic Privacy

By Alan McHughen

For just $399 (plus shipping and handling), the scientists at 23and me.com will scan your complete genome. The DNA analysis reports on 118 different medical and health dispositions, your maternal and paternal ethnic ancestry, and a curious bunch of genetic trivia concerning your persona (is your earwax sticky or flaky?). All you do is pay the money and spit into a collection tube; they extract your DNA from the spit and look for half a million single nucleotide polymorphisms (SNPs) scattered throughout your genome, including many in or near genes associated with particular traits. Other companies offer similar services. For example, Decodeme.com charges $985, but catalogs twice as many SNPs, and you collect your DNA with a cheek swab.

Alternatively, if you don’t need the complete genome scan but are curious about specific medical conditions or family lineage, you can get less expensive gene tests from an increasing number of companies willing to take your money and DNA sample in exchange for the genetic information their scientists reveal. If heart disease runs in your family, you may either relieve or exacerbate your anxieties by shelling out $200 to have a cardio scan for relevant genetic predispositions. Or, for as little as $99, a man can have his Y chromosome probed to confirm his place in the family patrilineage, and possibly connect to ancient and famous princes or pirates.

These genetic information services, with prices now well into recreational and hobby budget range, provide the most personal, private — and unchangeable— information possible about you. The sinister side of this fascinating field is all too often overlooked—it can reveal your most intimate genetic details to strangers and nosy neighbors. While the various testing labs assure confidentiality, there is little to no control over personal genetic information. In the US, anything you discard is salvageable by anyone else, and your trash can become another’s treasure if it carries blood, saliva, hair, semen or any other DNA-laden bodily secretions.

While we worry about identity theft, personal financial or other private information, our uniquely personal information is up for grabs. The Genetic Information Nondiscrimination Act (GINA) of 2008 offers some protection, but it is limited to employment and medical insurance issues. GINA does not protect your genetic information from being abused by life insurers. Or nosey neighbors. 

Genetic privacy raises a whole spectrum of social, ethical, legal and medical issues. Suppose your neighbor salvages your trash and has your DNA analyzed. This local gossip then shares the juicy news that you have a “higher than average predisposition” to, say, alcoholism. Soon, everyone in the community shuns you as a latent alcoholic, and you have no idea why. The community knows more about your genetic makeup than you do. And, because they don’t know how to interpret statistical language such as “a higher than average predisposition”, those conditions may easily be exaggerated into probabilities, if not certainties.

If people have a right to know their own genetic information, they have the obverse right to NOT know. People can choose to remain ignorant about their genetic makeup. Consider, for example, Huntington’s disease (HD). This death sentence is one of the few health conditions almost due to genetics, and the DNA assay has been available for years. Curiously, most people at risk, i.e., those with HD in their direct lineage, choose NOT to take the test; they prefer not to know until (or if) symptoms appear. What happens when the local busybody lets the cat out of the bag on HD? Word will get around and the at-risk person will inevitably find out, if only by the ‘different’ treatment by neighbors, thus obliterating the exercise of their right to remain ignorant. Whether the test result is positive or negative on HD is immaterial at this point, the rights will have been violated. The DNA test for HD is currently more elaborate than the simple SNP analysis, but because SNPs associated with HD are being reported, it’s only a matter of time before they come generally available.

Perhaps you’ve suspected the woman down the street had a child from an adulterous one night stand a few years ago, and the cuckold husband remains a doting, if clueless, dad. Now, with just $89 (including overnight FedEx delivery!) and a little misdemeanor creativity, well within the standard ethical bounds of busybodies, you can satisfy your suspicions with a surreptitious and discrete paternity test. And, to provoke some real excitement in your sleepy small town, show the results to the husband.

A few minutes of thought and discussion generates many other issues and examples of the precarious security of personal genetic information and identity, and the potentially dire consequences of genetic information getting out. Society is yet to discuss the privacy issues surrounding genetic identity as vigorously as we have with personal financial or medical records. It’s getting late. Do you know where your DNA is?

 

At Long Last: FDA Approves GSK's Cervarix

Without fanfare, GlaxoSmithKline (GSK) quietly announced today that the US Food and Drug Administration (FDA) granted approval for CERVARIX® [Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant] for the prevention of cervical pre-cancers and cervical cancer associated with oncogenic human papillomavirus (HPV) types 16 and 18 for use in girls and young women (aged 10-25).

It has taken GSK over three years to garner US regulatory approval for CERVARIX® which has been approved and used in over 100 other countries in the world. Early "unspecified concerns" delayed approval and, as recently as two weeks, FDA delayed a decision despite recommendations from an advisory panel to approve the vaccine. Coincidentally, a week before the agency was expected to announce approval for the vaccine, a British girl died after she was vaccinated with Cervarix. While FDA spokespersons claimed that the girl’s death following vaccination had nothing to do with the delaying a decision on Cervarix, many industry pundits believe that the FDA was reluctant to approve the vaccine in light of the sensational media coverage in the UK surrounding the incident. After an autopsy was performed on the girl, British authorities announced that a massive cardiac tumor that had infiltrated one of her lungs, not Cervarix was responsible for her death.

Today’s approval of Cervarix provides American consumers with an alterative to Gardasil, Merck’s cervical cancer vaccine that was approved about two years ago. That said, the ability to protect girls and young women from the possibility of developing cervical cancer is more important than which of the two vaccines is used to induce immunity. I plan on immunizing my daughter when she is old enough!

Until next time...

Good Luck and Good Job Hunting!!!!!!!

 

Biotechnology Salaries Lower Than Advertised?

There was an interesting post today at the Seattle, WA-based  Xconomy.com website about the salaries of people who work in the biotechnology industry. The post mainly focused on the salaries of biotech workers in the Pacific Northwest and based on results of a local survey the median salary is roughly around $60,000 per year. While this pales in comparison to the $81,499 reported earlier this spring from a group sponsored by the Pharmaceutical Research and Manufacturers Association (PhRMA), it is important to note that “real salary” data are difficult to obtain and much of what is released is based on salary figures that don’t include bonuses and other benefits. Further differences survey methodologies may also account for the seemingly disparate results. Nevertheless, salaries in biotech are generally better than those offered in other science-related industries and, not surprisingly, are highly dependent on degree requirements and job duties and responsibilities.

The bottom line: in my opinion, a job in biotech is a good career choice because of the projected upward growth for the industry. More importantly, pharma is continuing to abandon its reliance on small molecules and increasingly embracing biotechnology and its products as the future of the life sciences and healthcare industries. If I was undergraduate life sciences major today, I would be looking to the biotech and medical devices/devices industry, not pharma, for future long term employment!!! And, contrary to popular belief, a PhD degree is no longer a requirement for many biotechnology jobs.

Until next time...

Good Luck and Good Job Hunting!!!!!!

 

Allergan Sues FDA over Wrinkle in Off Label Use of Botox

Allergan, the maker of Botox and Latisse sued the US Food and Drug Administration (FDA) in federal court yesterday because it believes that regulations banning off label promotion of prescription drugs violates the company’s right to freedom of speech and impedes its ability to provide physicians with information regarding patient safety.

The company contends in a lawsuit filed Thursday that it should be able to educate doctors about the risks and benefits of using treatments for unapproved uses. Botox is approved for several uses by the Food and Drug Administration. In addition to its use as a wrinkle treatment, it is approved for eye muscle disorders and excessive underarm sweating. But physicians often use it for unapproved, or off-label, indications including muscle-spasm conditions.

The impetus for the lawsuit is an FDA requirement that the company provide new risk information education to physicians on Botox as a therapeutic treatment. According to an Allergan spokesperson, "Our reason for seeking action now relates to the fact that we have recently been required by FDA to initiate a REMS (Risk and Mitigation) program for Botox to ensure that physicians are equipped to evaluate the risks and benefits of treatment." In April, health officials warned doctors and patients about potentially deadly risks of using Botox and similar drugs for unapproved uses to treat certain types of muscle spasms. The drugs carried risks of rare botulism symptoms, particularly when given to children to help relax uncontrollable muscle movements.

Allergan estimates that 20% of Botox usage is off-label for unapproved indications. Because of this, the company believes that it is important to “proactively provide comprehensive information to physicians about these off-label uses, such as dosing guidelines, patient selection criteria and proper injection technique to ensure that physicians are equipped to treat patients as safely and successfully as possible. And, “without judicial relief, Allergan is unable to engage in a truthful and relevant information exchange with the medical community for fear of prosecution." 

It sounds to me like the lawsuit is more about increasing the annual sales of Botox for a growing number of unapproved indications rather than ensuring patient safety. These types of lawsuits have becoming increasingly popular because of previous legal precedent that extends an individual’s right to freedom of speech to corporations and other entities. However, more importantly, if Allergan is successful, it could signal the end of the regulations and ban on off label promotion of prescription drugs and devices. Is eliminating a few wrinkles from aging baby boomers (like me) worth all the trouble?

Until next time...

Good Luck and Good Job Hunting (hmm...maybe if I look younger I might be able to find a job?)

 

In a Surprise Move FDA Delays Ruling on Approval of GSK's Anti-Cervical Cancer Vaccine

A spokesperson at the US Food and Drug Administration (FDA) announced today that it decided to delay its decision whether or not to approve GlaxoSmithKline’s (GSK) anti-cervical cancer vaccine Cervarix. The agency was scheduled to announce its ruling Tuesday on whether to approve Cervarix, but a GSK spokeswoman said the review will continue. An agency spokesperson failed to disclose any reasons for the delay because FDA doesn’t comment on ongoing product reviews. This is the second regulatory delay for Cervarix in the past two years.

The delay comes as something of a surprise because earlier this Earlier this month, an outside panel of health experts voted that Cervarix appears safe and effective for girls and women ages 10 to 25. The FDA is not required to follow the group's advice, though it usually does. Cervarix already is approved in nearly 100 other countries, but has been delayed in the U.S. since 2007, when the FDA said it needed additional safety data.

An approval from FDA would allow London-based GSK to compete against Merck's blockbuster vaccine Gardasil, which has been on the US market following its approval in 2006. Based on all available published reports, Cervarix has a similar safety profile and efficacy profile as compared with Gardasil.

One of the issues with Cervarix may be the adjuvant use to formulate the vaccine to bolster anti-HPV immunity. While Merck's Gardasil uses an aluminum salt adjuvant, Cervarix uses a novel adjuvant known as AS04. The agency’s lack of familiarity with AS04 and possible concerns about its safety may be what is delaying the Cervarix decision. 

Stay tuned for further details!

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Word on the Street: Novartis to Buy AstraZeneca?

Fierce biotech reported today that word on the street is that the Swiss drug maker Novartis may tender an offer to acquire London-based AstraZeneca.

On the surface, the deal doesn’t make much business sense. However, Astra Zeneca’s purchase of the Maryland-based vaccine manufacturer MedImmune two years ago might make the company more attractive to Novartis which has a strong biotechnology pipeline and is looking to improve the competitiveness of its vaccine division.

AstraZeneca stock share price is soaring as a result of the rumors.

Stay tuned for the latest developments!

Novoseek: A Cool Search Engine for the Life Sciences

I previously posted an article on BioJobBlog about biomedical and scientific search engines. One of them called Novoseek, which is mainly geared for life scientists, has recently launched a new set of features known as  My Novoseek

My Novoseek allows users to create a personal account to store and manage indiviudal Novoseek searches. Its functionalities include:

  • Search history
  • Saved searches
  • Search labeling and indexing
  • New publication alerts
  • Account filtering and management

These newly introduced features improve Novoseek’s search capabilities, content management and convenience. For example, saving searches and creating alerts offers users a facile and convenient way to be alerted when new papers are published in your areas of interest. Also, Novoseek’s indexing and content management features makes creating and labeling collections of papers really easy. Finally, the ability to customize and manage account settings and view search histories makes searching for new information easier, less time consuming and prevents search redundancy.

While I haven’t spent much time evaluating other biomedical search engines, my experience with Novoseek has positive and I recommend that you check it out. Also, unlike other biomedical search engines, Novoseek has a distinctive social media bent and is using it to constantly add new features to meet new and exisitng user demands. To that end, Novoseek maintains its own blog to keep user abreast of happenings in the biomedical search engine world and can be found on Facebook and Twitter.

Signing up for Novoseek is easy, requires only three steps and only takes five minutes or less.

Please visit the Novoseek website and let me know what you think.

Until next time...

Good Luck and Good Searching!!!!!

 

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Late Breaking News: FDA Advisory Panel Recommends Approval of GSK's Cervical Cancer Vaccine, Cervarix®

The U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that clinical data support both the efficacy and safety of Cervarix®, GlaxoSmithKline (GSK) cervical cancer vaccine.

In a press release, the company announced that “Cervarix was shown to be highly effective and well tolerated in girls and young women for the prevention of cervical pre-cancers and cervical cancer related to human papillomavirus (HPV) types 16 and 18, the two most common virus types that cause cervical cancer. The committee also discussed data demonstrating the efficacy of  Cervarix against additional cancer-causing virus types.”

The Committee’s favorable recommendation, although not binding, will be considered by the FDA in its final review of the Biologics License Application (BLA) for the candidate vaccine.

In March 2009, GSK submitted final data from its Phase III pivotal study (HPV-008), the single largest efficacy trial of a cervical cancer vaccine to date. The file included data from clinical trials in more than 30 countries involving nearly 30,000 participants receiving Cervarix, which reflect an ethnically and racially diverse population and a broad range of women. It also included a thorough safety assessment relevant to 10-25 year old girls and young women.

Cervarix® has been approved in nearly 100 countries around the world, including the 27 member states of the European Union (EU), Australia, Brazil, South Korea, Mexico and Taiwan. Licensing applications have been submitted in more than 20 additional countries, including Japan and the United States. GSK also received World Health Organization (WHO) prequalification in July 2009.

The likely approval will provide girls and women with an alternative to Merck’s cervical cancer vaccine Gardasil which has been on the market for almost two years. Gardasil has recently come under fire by religious and anti-vaccine groups and sales have been lackluster lately. It will be interesting what effect if any Cervarix will have on the US anti-HPV/cervical cancer market. That said, I doubt whether Merck executives will be sleeping as well as they have been prior to today’s advisory panel recommendation!

For a great comparison of the two vaccines check out an article in today's New York Time business section.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!!

 

More Consolidation in the Pharmaceutical Industry

Sepracor shareholders may be able to sleep better at night without the aid of the company’s top selling insomnia drug Lunesta after agreeing to be purchased on Thursday by Dainippon Sunmitomo Pharma of Japan. Dainippon will pay $2.6 billion for the rights to Lunesta and other drugs in Sepracor’s pipeline. 

This is the third deal in the last two year involving the purchase of American pharmaceutical companies by Japanese drug makers seeking to aggressively expand their reach into the US drug markets. Last year, Takeda Pharmaceutical purchased Cambridge, MA-based Millenium Pharmaceuticals for $8.8 billion and Eisai brought MGI Pharma of Minnesota for $3.9 billion. 

Sepracor, a specialty pharmaceutical company founded in 1984 focused on strategy of developing single isomers or chiral drugs and active metabolites of top selling drugs with the goal of developing a pipeline of proprietary pharmaceutical products. The company’s most successful product is Lunesta, a prescription sleep aid that had sales of almost $500 million in 2008.

Last January, the company layed off 20% of its workforce (350 sales reps, plus 410 contract sales reps) as Lunesta sales slumped because of competition from generic versions of Ambien and branded Ambien CR and revenue losses from its Xopenex COPD franchise. It isn’t clear whether or not more Sepracor will shed more jobs after the Dainippon deal closes sometime next year. 

Stay tuned for updates!

Until next time...

Good Luck and Good Job Hunting!!!!

 

Upcoming Next Level Pharma Conferences: Outsourcing Clinical Drug Development

The increasing costs of conducting human clinical trials and the requirement for more stringent safety data for new molecular entities is forcing a growing number of pharmaceutical and biotechnology companies to outsource clinical development of new drugs to Central and Eastern Europe and Asia, most notably India. If your company is considering this option, you may be interested in attending an upcoming conference and workshop sponsored by Next Level Pharma. 

 “Clinical Outsourcing Alliances in Central & Eastern Europe” is a one day conference that will be held on October 8, 2009 in Boston, MA. Company representatives from American and European life science companies and clinical research organization will present talks on the “nuts and bolts” of setting up and conducting human clinical trials in Europe.

A half-day workshop entitled “Clinical Outsource Alliances in India” is being offered on day 2 of the conference. The workshop is intended to introduce American clinical trial sponsors interested in conducting human clinical trials in India to prospective Indian CROs. Presentations from American pharmaceutical executives and Indian CRO representatives will describe the realities of running clinical trials in India and allow attendees to identify potential clinical development partners.

Don’t miss this opportunity to learn the “ins” and “outs of outsourcing foreign clinical drug development.

Until next time...

Good Luck and Good Job Hunting!!!!!

Several US Legislators Begin to Seriously Scrutinize Direct-to-Consumer Advertising

Until today, direct-to-consumer advertising (DTC) has received very little attention during the recent spate of debates over healthcare reform. The NY Times reports that several members of Congress are introducing legislation that would curb the reach of DTC advertising. While reasons for introduction of new legislation vary—ranging from moral indignation over the mention of four hour erections during prime time to tax deductions for pharma companies that engage in DTC advertising—it appears that no stone will be unturned during the ongoing debate over US healthcare reform.

For those of you who may not know, DTC advertising is allowed in only two countries—New Zealand and the US. According to a Nielson Media Research report, in 2008 drug makers spent about $4.8 billion on DTC advertising for television, radio and print ads in magazines and newspapers. Not surprisingly, supporters of DTC point out that the amount of money spent by pharmaceutical and biotechnology companies on DTC advertising is negligible as percentage of total health care spending. Nevertheless, data convincingly show that DTC advertising can increase the number of prescriptions written for newly approved drugs. Of the $235 billion spent on prescription drugs last year, approximately $8 billion was attributed to DTC advertising.

Although some academic studies suggest that DTC advertising can help people who need to start taking drugs and others to remain compliant with existing treatment regimens, the lack of fair balance in many DTC ads that promote drug benefits and downplay risks is what is driving legislation to curb its use. The recent brouhahas over Pfizer’s Lipitor commercials, Bayer Pharmaceuticals’ ad that deceptively promoted its popular birth control drug Yaz and Merck and Schering Plough’s Vytorin ads that overstated the health benefits of the cholesterol lowering drug have convinced legislators that DTC must be fixed.

The US Food and Drug Administration (FDA) Division of Drug Advertising Marketing and Communications (DDMAC) oversees and has full responsibility for DTC advertising. However, it is important to note, that under current regulations, companies aren’t required to get approval from the agency before they appear. Sharing DTC ads with FDA is completely voluntary. However, if FDA receives enough complaints about particular ads, DDMAC will review them and notify the company if regulators believe that they contain information that is misleading, unbalanced or unsubstantiated. Companies that violate DDMAC policies and guidelines are typically required to show run all future DTC ads by FDA regulators before they can shown to the public.

Because of the small numbers of patients that are typically used during clinical evaluation of new drugs, it may take as long as five years before side effects and problems with certain drugs begin to emerge. With this in mind, DTC critics argue that there ought to be a five year waiting period or moratorium on DTC advertising after a drug is approved. Interestingly, about ten years ago, a friend who works for a major pharmaceutical company told me that she always waits five years before using a newly approved drug.  At the time, I thought it was an odd thing for her to say since she had been in the business for over 15 years. However over the past five years or so, several high profile drugs that were heavily promoted by DTC advertising had to be withdrawn from the market. To that end, while DTC advertising may be “great for business,” it may not always be in the best interest of American consumers who use prescription drugs!

Until next time...

Good Luck and Good Job Hunting

 

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Bristol-Myers Squibb to Buy Monoclonal Antibody Maker Medarex

Bristol-Myers Squibb (BMS) announced late yesterday that it intends to purchase Princeton, NJ-based Medarex for $2.1 billion. BMS and Medarex were working collaboratively to develop a monoclonal antibody called Ipilimumab as a treatment for late stage melanoma.

The acquisition represents BMS’s public commitment to transform itself into a “next generation pharmaceutical company” with both pharmaceutical and biotechnology products in its arsenal. Last year, BMS bought Kosan Biosciences, Inc a California-based biotechnology company developing novel cancer treatments. Also, as you may recall, BMS lost ImClone to Lilly in a bidding war over Erbitux—a monoclonal antibody-based colorectal cancer treatment that was co-marketed by BMS. 

Medarex was one of the last independent, public, late stage monoclonal antibody development companies in the biotechnology industry. Many of its competitors, like ImClone and Cambridge Antibody Technologies, had already been acquired by big pharma and I was wondering when Medarex would be acquired. I have always held Medarex in high regard and it is a solid and well position company. To that end, I recommended that my mother purchase Medarex stock several years ago telling her that I thought it had a huge upside. Not surprisingly, the stock has been soaring since the announcement; so much so that my mother called me today to tell me how smart I was—go figure.

It is not clear, at present, what effect, if any, the Medarex acquisition will have on the employment situation in New Jersey. Although BMS is headquartered in NYC, it has two large sites in New Jersey, one in Lawrenceville and the other in Plainsboro. As mentioned above Medarex is based in Princeton, NJ. BMS has been steadily downsizing over the past three years and I suspect that there may be more layoffs after the Medarex deal closes.  If there are layoffs, more are likely to occur on the Medarex side of the business.

While I have been critical of some of BMS’ strategic moves in the past, I think the Medarex acquisition is an outstanding one and BMS will likely benefit from it!

Until next time...

Good Luck and Good Job Hunting!!!

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Pharma Investing Less in R&D: What Does the Future Hold?

It’s no secret that major pharmaceutical companies are no longer investing in internal drug discovery initiatives as much as they have in the past. However, I was unaware how drastic the decline in R&D spending was until I read an article entitled “Significant Change Predicted for Bioindustry” by Benjamin J. Conway in the July issue of Genetic Engineering & Biotechnology News. 

Mr. Conway notes that in 1989 more than 50% of the pharmaceutical industry’s budget was spent on preclinical drug discovery and development. During the 1990s, the percentage slowly declined and was approximately 44% by 1999. He asserts that beginning in 2000, “the drop became precipitous” as pharmaceutical companies spent increasing amounts of their R&D budgets on downstream activities including expanded clinical trials. By 2006, big pharma was spending about 25% of its budget on R&D. Strikingly, Mr. Conway contends that “when measured in terms of constant absolute dollars, spending on pre-clinical R&D activities actually declined 0.4% annually over the period, despite annual increases of nearly 7% in total R&D spending.” 

Not surprisingly, the almost decade-long decrease in pharmaceutical R&D spending is best reflected in the lack of new drug approvals over the past five years or so. According to Mr. Conway, throughout the 1990s more than 50% of all new drug approvals originated at big pharma companies. By 2001, these companies were responsible for approximately 60% of new drug approvals. However, since then, pharma’s new drug approvals have plunged to 25% to 30% of annual totals. Some analysts suggest that the figure has been as low as 15%. The decline in new drug approvals almost parallels the decrease in R&D spending at most major pharmaceutical companies. Many industry analysts and thought leaders contend that big pharma companies have gotten too big and unwieldy and can no longer innovate. The unprecedented drops in pharma’s new drug approval rates tend to support that assertion. Mr. Conway points out that the so-called “innovation gap” has been filled by biopharmaceutical companies that “today account for 75% or more of new therapeutics developed each year.”

These changing market dynamics suggests that big pharma must reconfigure the business model that it has clung to for the past 50 years to remain competitive. Not surprisingly, almost all of the major pharmaceutical companies have begun to do just that! For example, over the past three years more than 60,000 R&D scientists have lost their jobs with little likelihood that the vacated jobs will ever be resurrected. Further, big pharmaceutical companies have increasingly begun to outsource many R&D activities to Asia, Eastern Europe and elsewhere. Finally, most big pharma companies have publicly demonstrated—through mergers and acquisitions—that biotechnology products as well as small molecules are in their future.

While big pharma may be retrenching and evolving, don’t expect the pharmaceutical industry on internal drug discovery initiatives —or small molecules for that matter— to disappear any time soon. The industry is going through a transitional period and the companies of the future will look only slightly different than they do today. These companies will still be large and well capitalized, but likely more diversified in their product portfolios (which will surely contain biotechnology drugs). Also, they will continue to excel in new product development, marketing and distribution. However, unlike the past, much less emphasis will be placed on internal R&D programs to discover new molecular entities. This means that pharmaceutical R&D operations will remain lean and companies will increasingly rely on M &A and licensing deals (with smaller specialty pharma and biotechnology companies) to keep their pipelines full.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!!

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Did You Know?

In his book, “Free: The Future of a Radical Price” Chris Anderson, editor of Wired Magazine, asserts that the cost of DNA sequencing falls 50% each year. To that end, in February, a company called Complete Genomics based in Mountain View, California, announced it will read entire human genomes at $5000 a shot, starting in June this year. This will cost less than one-tenth of what companies charge today for genome sequencing. 

If you believe Anderson, in five years sequencing a human genome will be under $100. Based on these calculations, the window of opportunity for companies that sequence genomic DNA to make a profit is closing rapidly. So, if you were considering getting into the DNA sequencing biz, the right time may be now—before it is no longer a profitable biz model.

Until next time...


Good Luck and Good Sequencing!!!!!!!!!!!
 

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Advertising on BioJobBlog

Many readers have contacted me about advertising on BioJobBlog. To accommodate those requests, I will be offering side bar ads no wider than 196 pixels to interested parties. Please contact me regarding the ad rates.

When I first started BioJobBlog I had no intention of advertising to generate revenue. Unfortunately, blog maintenance costs and the economy have taken its toll on me. I will try to continue to deliver interesting, relevant and uncompromising content to you despite the modest advertising revenue I hope to capture.

Thanks for reading my blog!

Until next time...

Good Luck and Good Job Hunting sic Advertising???

 

Search Engines for Life Scientists

Over the past few years, a number of search engines designed for the life sciences have appeared. I thought it might be informative for BioJobBlog readers to list some of the more popular ones and how they are used. I want to warn you in advance that this is not a comprehensive list. That said, if I’ve inadvertently omitted your favorite search engine, please feel free contact me or simply list it in the comments section for this post.

Scirus

Searches over 450 million scientific items, and allows researchers to search for not only journal content but also scientists’ homepages, courseware, pre-print server material, patents and institutional repository and website information. This site is owned and managed by Elsevier.

Novoseek

Search engine for biomedical literature in medline, grants and full text publications that will help you to: 1) retrieve meaningful documents related to your search, 2) narrow your search to find results in the relevant scientific journals and 3) identify the most relevant biomedical concepts for your query.

Mednar

Mednar is a free, publicly available medical research run by Deep Web Technologies.

Valdo 

A search engine that caters to all branches of life sciences. VADLO allows users to search within five categories: Protocols, Online Tools, Seminars, Databases and Software.

Life Sciences Search Engine

A customized search engine developed for the benefit of researchers in life science.

ScienceHack

A unique video search engine for science videos.

Intute

Formerly known as BIOME, Intute is a health and life sciences search engine for disease research.

BioScience Website

BioScience Website’s mission is to organize the world's biological science information and make it universally accessible and useful by utilizing the skyrocketing success of the World Wide Web.

BioNotebook 

A biology search engine run by the Pasteur Institute.

NextBio 

A search engine that enables life science researchers to search, discover, and share knowledge locked within public and proprietary data.

BioPages

Australian web portal and life sciences search engine.

Science Bucket

Specialized search engine that filters biology sites.

GoPubMed

Knowledge-based search engine for biomedical texts. It allows users to identify experts in the biomedical field.

Until next time...

Good Luck and Good Searching!!!!!!!!

 

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Obama Seeks Compromise on Length of Data Exclusivity for Follow-on Biologics

As the Congressional debate over follow-on biologics slogs on, the Obama Administration has finally weighed in and backs 7 years of data exclusivity for follow-on biologics. As you may recall, innovator companies want a 12-14 year data exclusivity period whereas follow-on biologics manufacturers are seeking a 5-year period (which is identical to the data exclusivity period for small molecules generic drugs outlined in the Hatch Waxman Act). What this means—based on the Obama Administration's proposal—is that a follow-on biologic manufacturer must wait seven years from the date of approval for the innovator (branded) drug before the US Food and Drug Administration could consider approval of a follow-on version of the molecule.

It is not surprising that the Obama Administration supports a 7 data exclusivity period--it is, after all, a compromise between the 5 year period sought by the follow-on manufacturers and the 12-14 years that the innovator companies are seeking. And, Mr Obama has repeatedly shown a willingness to compromise when it comes to getting important legislation passed. Hopefully, Congress will take the Obama Administration's compromise to heart and pass follow-on biologics legislation as quickly as possible.

 Until next time...

 Good Luck and Good Job Hunting!

 

 

Another Sign That Pharma Companies Will Rely Less on Internal R&D Programs

The drug maker Eli Lilly and Co quietly launched a new website today for a program dubbed Lilly Phenotypic Drug Discovery Initiative or PD2. According to the company, “The PD2 initiative is a unique opportunity for investigators from external institutions to submit proprietary compounds for potential screening in Lilly's phenotypic assay panel. This highly collaborative process is enabled by a web-based application that facilitates efficient transfer of information between Lilly and the investigator. The PD2 screening panel is currently comprised of five modules which are relevant to therapeutic areas of long-term strategic interest, including oncology, neurological disorders, and metabolic diseases. This panel may change over time to reflect additional research interests.”

Company officials believe that program will allow it to evaluate and possibly license treatments from biotech companies and academic institutions "that are never fully evaluated as potential drug candidates." The launch of the PD2 website—perhaps the first of its kind—clearly sends a signal that pharmaceutical companies are reducing their reliance on internal discovery programs to identify prospective new molecular entities and are eager to enter into licensing deals to find and acquire them. 

Membership in the PD2 requires that a legal representative from the investigator's academic institution or biotech company executes a Material Transfer Agreement (MTA). Once the MTA is reviewed and approved by Lilly officials, the institution can create an account. Until that time, use of the site is limited to browsing only. I have no doubt that technology transfer offices at most major universities will be signing up for membership in short order.

I think the PD2 initiative is an innovative and timely one given the massive reductions in R&D jobs that have taken place at many pharma companies over the past two years. Expect other pharma companies to follow Lilly’s lead.

Until next time....

Good Luck and Good Job Hunting!!!!!

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Looking to the East: GlaxoSmithKline Inks a Deal with India's Dr. Reddy's Laboratories

GlaxoSmithKline (GSK) inked a deal yesterday with the Indian generics manufacturer Dr. Reddy’s Laboratories giving it access to over 100 future generic drugs and a gateway to Asia’s emerging pharmaceutical markets. The therapeutic areas covered under the agreement include diabetes, cardiovascular, pain management, gastroenterology and oncology. Dr Reddy’s Laboratories is one of India’s largest generic drug manufacturers. Like many of its competitors, Dr. Reddy’s Laboratories also have active development programs for new biotechnology drugs and biosimilar products.

UK-based, GSK joins a growing number of pharmaceutical companies including Pfizer, Merck and others that have entered into deals with major generic drug manufacturers—or purchased smaller generics companies—to gain access to generics pipelines and an ability to compete in emerging  non-branded pharmaceutical markets. Impending US healthcare reform and downward pricing pressures (resulting from increased global competition) have forced drug makers to reevaluate the role that generic drugs will likely play in future pharmaceutical revenue streams.

While generic drug makers have outstanding manufacturing capabilities, they generally lack the marketing, sales and distribution channels necessary to penetrate foreign markets and quickly ramp up drug sales. I suspect that the number of deals between pharmaceutical companies and generic manufacturers will continue to increase as many of the patents for multibillion, blockbuster drugs continue to expire in the next few years.

Until next time....

Good Luck and Good Job Hunting!!!!!!!!!

 

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