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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.

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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!!!!!!!!!

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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)!!!!!! 

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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!!!

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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

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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

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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!!!!!!!!!

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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!!!!!!!!!!

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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!!!!!!!!!!

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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!!!!!!

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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)

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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!!!!!!!

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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!!!!!!

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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. 

To watch the full interview, please visit Meettheboss.TV

Until next time....

Good Luck and Good Viewing!!!!!!!!

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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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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 28^th 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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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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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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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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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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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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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!!!!!!!

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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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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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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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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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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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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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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!

Until next time....

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

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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!!!!!!!!

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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 (Fabray 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, Fabray 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 !!!

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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!!!!!!!!

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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!!!!

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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!!!!!!!!

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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!!!!

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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!!!!!!!!!

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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)

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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!!!!!!!!!!

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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!!!!!! 

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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?

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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!!!!!!!

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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!!!!!!

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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?)

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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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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!

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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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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!!!!!!!!!!

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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!!!!

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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!!!!!

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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 (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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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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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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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???

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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

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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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!

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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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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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