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Sandoz, the generics division of Novartis, is currently the world leader in the biosimilar market. In fact, if it was not for Sandoz, the biosimilar industry may never have gotten started in the first place! As some of you may know, Sandoz sued FDA (and won) to gain approval of its biosimilar human growth hormone. While FDA contends that Omnitrope is not really a biosimilar (it was approved as a “drug” rather than a biologic) most analysts agree that it was the first biosimilar product ever approved and sold in the US. 

As part of its global biosimilar strategy, Sandoz today announced that it had initiated Phase III clinical trails for US approval of biosimilar version of recombinant human granulocyte-colony stimulating factor(G-CSF) or filgrastim (Amgen’s Neupogen®) and another for global launch of PEG-filgrastim (Amgen’s Neulasta®); a PEGylated form of G-CSF.

The filgrastim study is designed to evaluate the efficacy and safety of Sandoz's biosimilar filgrastim versus Neupogen® in breast cancer patients eligible for myelosuppressive chemotherapy treatment. These trials expected to support extension of commercialization to the US, the largest global market for biologics. The pegfilgrastim study, which is being conducted in breast cancer patients undergoing myelosuppressive chemotherapy treatment, represents the next major step in the Sandoz global biosimilar development program. Previously, Sandoz announced that it had initiated late stage clinical trials for a biosimilar version of Roche’s monoclonal antibody cancer treatment Rituxan®). Finally, Sandoz has eight to ten different biosimilar molecules at various stages of development in its pipeline.

Sandoz currently markets and sells three biosimilars: filgrastim (Zario®), somatropin (Omnitrope®) and epoetin alfa (Binocrit®) in countries across Europe and elsewhere. As mentioned above Omnitrope is also sold in the US. However, because FDA has yet to craft a regulatory approval pathway for biosimilars (despite legislation mandating their approval) it is illegal to sell biosimilars (with the exception of Omnitrope) in the US.

Once vilified and staunchly opposed by most major pharmaceutical and biotechnology companies, the biosimilar business has been picking up steam in the past few years. To that end, companies like Merck, Pfizer, Teva and more recently Amgen and Biogen (all of whom lobbied against an approval pathway for biosimilars in the US) announced plans to compete on the global biosimilar market.

The decision of these companies to enter the biosimilar market is largely a result of downward pricing pressures on pharmaceutical and biotechnology drugs and near-empty drug pipelines at most major life sciences companies. Nevertheless, it is still not clear whether or not a robust biosimilar market truly exists. To wit, biosimilars have been in the market in the EU for the past fiver years and have not gained much traction there. However, the real biosimilar markets probably exist in China, Brazil and other emerging countries where there are large populations and emerging middle classes but drug prices are under tight government regulation. Because of this, the uptake of biosimilars in these markets will likely be greater than in Europe and the US.

Until next time...

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

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A study conducted in November 2011 by Cegedim Strategic Data, a market research and promotional audit firm analyzed the world’s top 100 pharmaceutical companies expenditure on traditional promotional (marketing spends) and then compared that spending with their presence on Facebook and Twitter.

Not surprisingly, Pfizer, Novartis and Merck (the world’s largest big pharma companies) finished in the top three for traditional promotional spending. However, their use of social media i.e. Twitter and Facebook varied widely. For example, Pfizer—the top promotional spender—was first in its number of Twitter followers and third in the number of likes on Facebook. On the other hand, second ranked Novartis was fifth in the number of Twitter followers and in seventeenth position for likes on Facebook. Finally, third ranked Merck was fifteenth in the number of Twitter followers (third for the number of tweets) and in the tenth position for the number of likes on Facebook (but has more pages than any of its Facebook competitors).

Other notable companies included:

• Johnson &Johnson, eleventh in promotional spending and number two on the number of Facebook likes
• Roche, number fifteen on the promotional spending list was ranked number two for the number of Twitter followers
• Proctor and Gamble which ranked a distant 54^th in promotional spending was number four on the Twitter follower list

What does this all mean? A whole lot of nothing because nobody can determine what effects the use of social media has on the bottom line for most pharmaceutical companies. Unlike other industries, where social media can be used to sell products, it cannot be used for direct promotional purposes in the life sciences industry. While most people will tell you this is because of the lack of guidance by FDA on the use of social media, the bottom line is that social media will never be allowed for direct-to-consumer advertising in the pharmaceutical industry. That said, pharma and biotech will have to find other uses for social media including clinical trial recruitment and retention, adverse event reporting, employee recruitment and retention and education and outreach.

Until next time...

Good Luck and Good Tweeting (and Liking)

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

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

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

Until next time...

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

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

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

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

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

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

Until next time...

Good Luck and Good Job Hunting

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The Pharmalot Blog today reported that a Wall Street Journal article indicated that Pfizer is planning to cut $1.0 billion from its operating budget by 2012. As many of you may recall (especially those who lost their jobs) the world’s largest pharmaceutical company cut 1,100 earlier this year at its research facilities in Groton CT. The new cuts are aimed at reducing Pfizer’s R&D expenses by up to $2.9 billion annually.

The $1.0 billion in cuts is primarily aimed at reducing administrative and management duplications at Pfizer’s headquarters in NYC and worldwide. Other expenses to be trimmed include those related to promotions, travel, entertainment, consultants, print materials and supplies and electronic equipment. While there is no doubt that these cuts will help to control costs, I suspect that substantially more money could be saved if pharma executive salaries and bonuses were also trimmed.

While it is unclear what the additional $1.0 billion in cuts will have on scientists, I suspect it won’t be good. In case you have not noticed by now, Pfizer like many of its competitors are getting out of the R&D business. This means that R&D jobs will continue to dwindle and scientists will continue to struggle to find jobs in a highly competitive job market.

Since Pfizer purchased rival Wyeth Pharmaceuticals in 2009, the company has shed over 20,000 jobs. The reason for the job cuts and massive cost cutting measures at Pfizer is the loss of patent protection in 2012 for its top selling cholesterol medication Lipitor ($10.7 billion in sales) and its ED drug Viagra ($1.9 billion in sales). Last year Pfizer lost patent protection the antidepressant Effexor (peak sales of $3.8 billion) and the Alzheimer’s drug Aricept ($417 million in sales). Also, when mergers take place there is much overlap and duplication of effort that takes several years to sort out.

Don’t be surprised if new Pfizer job cuts are announced late next fall! Now, would be a good time for Pfizer scientists to remove the dust from their CVs; if it is not already too late!

Until next time...

Good Luck and Good Job Hunting!!!!!

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Until next time,

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

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

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

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

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

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

Until next time...

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

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Mark Senak, author of the highly informative and well written Eye on FDA blog, reported today that a recent article that appeared on the American Medical News website suggests that the US Food and Drug Administration (FDA) may be considering regulating mobile apps that contain medical or clinical components. While the agency has yet to officially publish guidance on the use of social media in the life sciences industry, it now appears that FDA may be turning its attention on the development of mobile apps; one of the fastest growing segments of the social media movement.

The reason why FDA is taking notice of mobile apps is because a handful of app developers have sought and received FDA clearance for their mobile apps that—because of clinical components —are considered to be “medical devices.” As many of you may know, medical devices which include band-aids, surgical instruments, heart monitors, cardiovascular stents and diagnostic kits, all must receive marketing approval by the agency before they can be sold in the US. Although the agency yet to craft any guidance for clinical/medical app development, it makes sense that FDA ought to evaluate and regulate these products to insure that they are medically-effective and safe. 

According to the American Medical News article, the first app developer to receive FDA market clearance was AirStrip Technologies in San Antonio, for its AirStrip OB application. The app, which was approved in 2009, allows physicians to monitor mother and newborn remotely during delivery. In February, the FDA granted clearance to MobiUS, an app developed by Mobisante, a medical device company in Redmond, Wash. The app permits viewing of medical images for diagnostic purposes. Mobile MIM, a remote diagnostic imaging tool developed by Cleveland-based MIM Software, was also granted market clearance that month. A number of pharmaceutical companies, most notably Pfizer, have been extremely active in the mobile clinical app development space.

The reason why it makes sense for FDA to regulate certain clinical/medical apps is because physicians will rely on them to make medical decisions. For example, the AirStrip OB mentioned above will ostensibly allow physicians to remotely monitor a mother and neonate during delivery. Consequently, the app, aka device, must be evaluated by the agency to determine whether or not it can be used safely and effectively by physicians during childbirth. In this case, the app is similar to a heart monitor that is used during childbirth. And, like all other medical devices, the heart monitor required FDA clearance to determine its safety and effectiveness, before it could be used in real-life childbirth situations. To that end, the agency has hinted that it will be much more proactive in monitoring this new class of devices.

I have no doubt that many pharmaceutical companies and medical devices manufacturers will not be pleased when they learn that the agency is going to “stick its nose” into mobile app development. Nevertheless, in my opinion, if a mobile app is going to be used in possible “life or death” situation, then it ought to be regulated by FDA—the agency that is legally responsible for regulating these types of products. That said, Eye on FDA’s Mark Senak raises a number of valid and insightful points about FDA and its possible role in mobile app development.

“Related to a possible guidance for apps, there are a lot of questions that need to be answered when considering its development – when is an app a medical app?  When does it require regulation?  Who will pay for the oversight – will there be App Developers User Fee Act (ADUFA?) and if so, what will that do to the price and to access.  Will insurance companies have to cover apps?  And what will the process for approval be – something like a 510(k)?”

Finally, I think that the app developers who proactively approached FDA for guidance abut the clinical apps that they were developing “got it right.” This will get the agency “thinking” about clinical/mobile apps and how they ought to be approved and regulated in the future. In turn, this will provide future app developers with a clear regulatory framework that will guide the development of cost effective, safe and efficacious mobile clinical apps.

Until next time...

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

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

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

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

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

Until next time..

Good Luck and Good Job Hunting!!!!!

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

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

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

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

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

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

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

Until next time...

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

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

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

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

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

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

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

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

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

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

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

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

Until next time...

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

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While R&D scientists and sales representatives continue to struggle to find jobs in the US at pharmaceutical and biotechnology companies, the competition is fierce to hire and retain pharma employees in emerging markets like China and India. Earlier this week, I posted a piece on big pharma’s continuing expansion of its R&D activities in Asia and the growing need for US-trained PhDs in this region. However, it appears that hiring and retaining pharma sales reps is a bigger problem in China and India for big pharma companies like GlaxoSmithKline (GSK), Sanofi-Aventis (SA) and Pfizer.

According to a recent article in Bloomberg News about 20 percent of GSK’s sales forces in both countries quits each year in favor of better offers from its rivals including Pfizer and SA. One GSK executive quipped “There’s a huge war for talent. It’s hard to do anything about. If you have a good person, they could find someone else willing to pay twice as much.” This is in marked contrast with the US where almost 100,000 pharma sales reps may have lost jobs over the past five years.

Emerging Asia Pacific markets accounted for roughly 17 percent of GSK’s sales in 2010 as compared with 18 percent for Pfizer and 30 percent for SA. Sales revenues for most major pharmaceutical companies declined in both the US and Europe last year. There is no question that big pharma is turning to emerging markets as a means to maintain and increase sales of drugs after patents expire and generic competition cuts into revenue. Sales in emerging markets are predicted to reach about $400 billion by 2020 which is equivalent to the current size of the US and the five biggest European markets combined!

By its own admission, GSK was “fairly late” in their investments in China and may explain why the company may be experiencing trouble with competing for talent in that market. Employment opportunities in emerging markets will likely resemble those in the late 1990s in the US and Europe, when there was a dearth of talents life sciences professionals and companies were willing to pay large salaries (regardless of whether or not job candidates were qualified) to employees to maintain operations. This trend is driving up labor costs in China and interestingly, China is beginning to outsource work to Vietnam, Malaysia and Singapore where labor and raw materials costs are less expensive.

Until next time....

Good Luck and Good Job Hunting (Go East Young Man and Woman)

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Mathew Herper, who writes at the Forbes Blog, reported today that according to a report compiled by the outplacement firm Challenger, Gray and Christmas, since 2000 the pharmaceutical industry cut 297,650 jobs. According to Herper “that is about as many people as currently work at the three largest drug makers — Pfizer, Merck, and GlaxoSmithKline — combined.” As he aptly points out “Many of those who were laid off were probably hired back by other drug makers. Some folks have probably been laid off more than once. It’s also worth noting that big mergers are one reason for the cuts.”

Nevertheless, the number of lost jobs is staggering. Interestingly, while almost 300,000 jobs have been lost in the last decade, a majority of the cuts (234,814) have taken place over the past six years (see below).   It is not clear from the report whether or not these numbers include the numbers of jobs lost by the aggregate life sciences industry (including biotech and specialty pharma) or only by the pharmaceutical sector.    

   Source: Challenger, Gray & Christmas, Inc. © (via the Forbes Blog)

With mergers on the way and more jobs being outsourced to Asia and elsewhere, don’t be surprised if the total number of layoffs continues to grow.

Until next time

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

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

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

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

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

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

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

Until next time…

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

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

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

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

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

Further he noted:

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

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

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

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

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

Until next time....

Good Luck and Good Job Hunting!!!!!

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Many industry insiders and financial analysts were pleased when former Pfizer CEO Jeffrey Kindler abruptly departed the company last December. Most felt that the company had grown too large after three mega-mergers and acquisitions (Warner Lambert, Pharmacia and most recently Wyeth) in the past decade or so. Pfizer bought Wyeth in late 2009 for $67 billion with the hope that it bolster the company’s drug development pipeline and replace vanishing Lipitor revenue (the move has not paid off which may explain Kindler unexpected departure).

Further, Pfizer’s best selling (and world leading) cholesterol-lowering drug Lipitor is due to lose patent protection in 2012. Lipitor had $10.7 billion in sales last year. This, along with the loss of patent protection for Viagra and a few other Pfizer prescription drugs, presumably left new CEO Ian Read, little choice but to slash R&D spending by close to $2 billion. Consequently, the company today announced it would close its research facility in Sandwich, England (which developed Viagra) and eliminate most of its 2,400 employees. An additional 1,000 employees at its research center in Groton, CT will either be offered transfers to its Cambridge, MA facility or layed off.

The elimination of 3500 Pfizer R&D employees begs the question “who will do the research to discover new drugs?” Not surprisingly, Pfizer’s answer is to outsource the work to Contract Research Organizations like Covance, Charles Rivers Laboratories and Parexel International Corp. Interestingly, much of this work is conducted by scientists who work outside of the US. And, if this down sizing trend continues how will the US ever get its unemployment rate below 10 percent?

Pfizer, like most other major US pharmaceutical companies, is no stranger to massive downsizing. The company alone has layed off over 19,000 employees over the past three years. And, unlike contractions in the life sciences industry in the past, I highly doubt that many of these R&D positions will be reinstated in the future. With this in mind, I highly recommend that those of you who were considering industrial R&D careers have a plan B or possibly a plan C to fall back on.

Until next time...

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

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

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

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

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

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

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

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

Until next time...

Good Luck and Good Job Hunting!!!!

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The fiscal year at most life sciences companies is drawing to a close, new budgets are being crafted and the holiday season is almost upon us. In years past, this time of year typically meant that it was bonus time for most pharma workers. Sadly, over the past three years bonus time has been replaced by layoff time. And, unfortunately the upcoming holiday season may not be joyous for many Pfizer and Roche employees.

Yesterday, Pfizer indicated that it may lay off up to 11,700 more employees than the 19,500 it had announced in connection with the buyout last year of Wyeth Pharmaceuticals. While Pfizer confirmed that it would be reducing its worldwide work force by more than the originally expected 19,500 the exact number remains a mystery. However, a quarterly report filed Friday with the U.S. Securities and Exchange Commission stated that Pfizer has estimated termination costs for 46,600 employees, while only 33,400 workers had actually been laid off as of Oct. 3. This appears to suggest that the company plans to reduce its work force by 11,700 more than originally announced, given that Pfizer is only 1,500 positions away from fulfilling its job-elimination pledge related to the Wyeth merger.

The additional job cuts—if they are realized—would amount to about 10 percent of Pfizer’s worldwide work force. If a reduction of that magnitude were applied to Pfizer drug-research sites in Groton and New London, which currently employ nearly 5,000 workers, about 500 jobs would be lost. The company in January 2009 announced that cuts would total 15 percent of the combined Pfizer and Wyeth work force. At the time, the combined work force numbered about 130,000; the latest official figure places that number at 111,500.

In other news, Roche today announced plans to cut 4,800 jobs, or 6 percent of its worldwide workforce of 82,000. Today’s announcement confirms the news leak three months ago (reported by the Pharmalot Blog) which suggested that job cuts would be likely during the fall.

According to today’s press release, technical operations activities will be reorganized in California, Mannheim, Germany and various other sites, resulting in the elimination of 750 jobs. The company also intends to sell sites in Florence, South Carolina and Boulder, Colorado; shedding an additional 600 jobs. About 1,200 jobs will be cut in the North American commercial operations, mainly in Roche’s primary-care business, while 700 positions will be lost in commercial operations in Europe.

R&D will also be affected. The company will discontinue activities in research and early development in RNA interference in Kulmbach, Germany, Nutley, New Jersey, and Madison, Wisconsin. Also, there are plans to reorganize other operations at these sites which will eliminate another 600 jobs.

Until next time...

Good Luck and Good Job Hunting (are there any left?)!!!!

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

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

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

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

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

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

Until next time….

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

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Unlike most of its competitors, which are downsizing operations, the Swiss drug maker Novartis yesterday announced plans to double the size of a planned office and laboratory complex in Cambridge, MA. A company spokesperson said that the expansion which will cost $600 million was part of a plan to bolster Novartis’ research operations and strengthen partnerships with local universities and biotechnology start ups. 

Novartis, Cambridge, MA largest corporate employer, expects to hire an additional 200 to 300 employs over the next five years increasing the size of its workforce in the city to 2,300.

Cambridge has become a something of a Mecca to pharmaceutical companies looking to tap into scientific information and intellectual property at Harvard and MIT and forging alliances or partnerships with early-stage biotechnology companies. In addition to the Novartis Research Institute, other companies in and around Cambridge include Sanofi-Aventis—which, last summer, unveiled a $65 million expansion in Cambridgeport that will house a new cancer research division and create 300 new jobs—AstraZeneca, GlaxoSmithKline, Shire and Pfizer.

In addition to its plan to expand operations and R&D capability in Cambridge, Novartis has agreed to build a $1.0 billion complex of offices and laboratories in Shanghai, China. Novartis like most other big pharma companies is trying to leverage scientific information and talent anywhere in the world to bolster their rapidly dwindling drug pipelines. 

The upside of Novartis’ Cambridge project is that it will help to create new construction, support and additional pharmaceutical jobs and help the city weather ongoing recessionary times. Who knows; maybe this is a sign that the US economy is growing and good times may be just around the corner!

Until next time...

Good Luck and Good Job Hunting (I highly recommend Cambridge MA)

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

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

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

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

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

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

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

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

Until next time...

Good Luck and Good Job Hunting!!!!!

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

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

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

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

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

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

Until next time...

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

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

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

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

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

Until next time...

Good Luck and Good Job Hunting

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

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

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

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

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

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

Until next time

Good Luck and Good Job Hunting

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

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

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

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

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

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

Until next time,

Good Luck and Good Job Hunting!!!!

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When I saw one of today’s headlines, ‘FDA Warns on Increased Death Risk with Pfizer Antibiotic’ I immediately dropped what I was doing to read the article. Expecting the worse, I learned that the US Food and Drug Administration (FDA) announced today that it was modifying the label for Pfizer’s antibiotic called Tygacil.

The reason for the label changes was new clinical information that showed that patients with ventilator-associated pneumonia (VAP) and diabetic food infections that are treated with Tygacil are at increased risk of death as compared with those treated with other antibiotic treatments.

"The FDA said it looked at 13 trials with patients given Tygacil for both approved and unapproved indications by type of infection comparing the overall mortality for Tygacil with other antibiotics. Overall, the studies showed death occurred in 4% of patients receiving Tygacil, or 150 out of 3788, and 3% of patients, or 110 of 3646, receiving comparator antibiotics."

While I didn’t find the difference in the mortality rates that shocking, it is important to point out that Tygacil is not an FDA-approved treatment for either VAP or diabetic foot infections. Nevertheless, the antibiotic is routinely used by many infectious diseases physicians as a treatment for both infections. This is because many VAP and diabetic foot infections are caused my multiple drug resistant bacteria and physicians are willing to resort to unapproved treatments (like Tygacil) to treat high risk patients. Put simply, there is generally little choice; either use Tygacil or the patient may die! 

Further, the 1% difference in mortality rates between Tygacil and other antibiotics may not be clinically significant because many of the treated patients are seriously ill and near death anyway. Finally, differences in the mortality were based on retrospective results from clinical studies that were designed to assess the safety and efficacy of Tygacil for indications other than VAP or diabetic foot infections. Consequently, it is difficult to conclusively say whether or not Tygacil is less safe than other antibiotics to treat patients with severe bacterial infections like VAP and diabetic foot.

Nevertheless, Tygacil's label has already been updated to warn doctors about the possible death risk. Pfizer sent a letter dated July 26 to health care professionals detailing the new label. The label change is listed below:

"Alternatives to Tygacil should be considered in patients with severe infections. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of this product to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:"

The bottom line: the jury is still out on the safety and efficacy of Tygacil as a treatment for VAP and diabetic foot infections. This can only be determined when well controlled, statistically-relevant clinical trials are designed and conducted. While FDA was correct to insist that Pfizer send a note to infectious diseases physicians alerting them of possible increased risks, I don’t think that the label change was newsworthy enough to earn the headline ‘FDA Warns on Increased Death Risk with Pfizer Antibiotic’ It is a shame that journalists continue to insist on publishing sensationalistic and often times inaccurate scientific headlines. While it may garner some additional readers, it does little to instill American confidence in our public health system.

Until next time...

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

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The Pharmalot Blog reported today that a survey conducted by the outsourcing firm Challenger, Gray & Christmas shows that only 200 pharmaceutical employees lost jobs in August. This compared with the 2,023 jobs lost in July, 830 in June and the 6,943 in May. According to the post, this year’s job loss tally is 37,265 as compared with 53,004 in 2009.  Since 2007, it has been estimated that over 180,000 life sciences employees have lost their jobs.

While the slowing layoffs are encouraging, there are no signs that companies are going to be hiring in 2011 (unless you are willing to relocate to Asia). Further, while layoffs are slowing a big pharma companies, the number of scientists losing their jobs at biotechnology companies because of insufficient capital or merger and acquisition activities remains steady and will likely increase if Sanofi-Aventis purchases Genzyme and other biotechnology companies are purchased. For example, Pfizer announced today that it was purchasing FoldRx for an undisclosed amount. FoldRx’s pipeline contains preclinical and clinical candidates for investigational new drugs that treat diseases caused by protein misfolding. The acquisition is consistent with Pfizer’s intention to move into the orphan drug market.

From an historical perspective, the early 2000s was the golden age for life sciences employees in most Western countries. Unfortunately, the golden age has ended for Western employees and it appears that a new era for pharmaceutical and biotechnology employees is beginning in the Asia, South America and Africa!

Until next time...

Good Luck and Good Job Hunting

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

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

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

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

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

Hat tip to Ed at Pharmalot!

Until next time...

Good Luck and Good Job Hunting (try clinical microbiology)

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While Pfizer has rapidly elevated its standing in life sciences social media circles, the announcement today that it is creating a “social media channel” on SlideShare suggests that the company may be over thinking its social media strategy. I have nothing against SlideShare (I even have some of my own presentations on the site) but SlideShare isn’t exactly a “household name” in social media circles. And, IMHO it isn’t exactly the most flexible or interactive social media platform available today. 

Ray Kerins Pfizer’s Vice President for External Affairs and Worldwide Communication proclaimed in as statement prepared for the channel’s launch: 

"This channel offers an integrated social media experience, delivering a variety of content -- presentations, video, blog posts -- via the largest online resource for sharing presentations.”We’re pleased to be the first company in a regulated industry to create a custom channel on SlideShare." 

Its launch was announced today at the 6th Annual PR & Communications ExL Pharma Summit being held this week at Pfizer’s New York world headquarters. After learning about the launch I visited the “channel” to have a peek.

Expecting a treasure drove of Pfizer blog posts, videos and other content I was sadly disappointed to find only a handful of PowerPoint presentations about Pfizer’s finances and quarterly results at the site (there were no blog posts, no videos, no followers and no tweets as promised). Also, it appears that the comments and wall section are currently disabled (I logged into my SlideShare account and was still unable to comment on the Pfizer site although @skypen managed to post a comment there). Although Pfizer may think it is leading the pharmaceutical social media vanguard, the launch of its SlideShare channel has already violated one of the basic tenets of social media— no over promising. And, for now, it appears that the Pfizer channel has been set up as a broadcast medium rather than an interactive one—another big no-no in social media circles. 

Maybe I expected too much of Pfizer (after hearing Ray talk at several social media conferences) and I am being too critical. But, launching a social media channel devoid of content and interactive feature is no longer de rigueur on the social web.  If this is what the world’s largest, and possibly one of the most social-media savvy, pharmaceutical companies has to offer, then we may be in for a long and bumpy social media ride in the life sciences industry!!!! 

Until next time... 

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

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

The Growth of High Throughput Screening

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

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

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

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

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

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

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

Stay tuned for more details.

Until next time...

Good Luck and Good Job Hunting

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The Internet and print media were buzzing this past week about the decision by a US Food and Drug Administration (FDA) panel of expert medical reviewers to not recommend approval of Boehringer Ingelheim flibanserin; a new medication to treat female sexual dysfunction or perhaps more apt lack of sexual interest.

Flibanserin was originally developed as an antidepressant but while it failed to treat depression women who participated in clinical trials reported increased sexual interest. The lack of drugs to treat female sexual dysfunction propelled Boehringer to continue to develop flibanserin to treat low libido in women. Previously, drug makers attempted to develop Viagra-like drugs and testosterone patches (testosterone increases sexual desire) to increase female libido—neither worked (without substantial side effects) to warrant approval. The FDA panel decided to not recommend flibanserin for approval because its modest effects on heightening female sexual desire did not outweigh side effects like dizziness and nausea.

A 2005 article in Nature Reviews Drug Discovery suggested that the size of the female sexual dysfunction market in the US could exceed $4 billion annually with only about 15 per cent of patients receiving treatment. Not surprisingly, many pharmaceutical companies have invested billions to develop new drugs to treat this indication.

There is no question that quality of life drugs like Viagra, Latisse and Botox generate billions of dollars in sales each year. While these drugs may help small numbers of patients who truly suffer from serious medical conditions, they are mainly used for so-called recreational purposes (sexual performance and beauty enhancement) by a majority of “patients.” That said, pharmaceutical companies have the right to develop whatever drugs or treatments that they choose. However, I contend that there are more serious medical conditions out there than failure to achieve orgasm or the need to not apply mascara on a daily basis.

Hat tip to Ed at Pharmalot for some outstanding investigative reporting!

Until next time...

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

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

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

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

Until next time...

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

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

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

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

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

Until next time...

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

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About a year ago I posted an article to BioJobBlog that suggested that social media can be leveraged to improve clinical trial recruitment to test investigational new drug candidates. Yesterday, Mark Senak, author of the EyeonFDA posted an article which suggested that the use of video on YouTube and other video-viewing sites makes complete sense to recruit prospective participants for human clinical trials. Here are some of Mark’s thoughts on the topic:

“The reasons I think video is a good way to expose people to learning about clinical trials are multiple. First, it allows me as a prospective clinical trial participant to learn about a clinical trial when I want to learn about it and where I want to learn about it - a hallmark of social media.  Second, it is private - I can learn from a video that can be developed to address a wide range of issues - issues that I might not be so comfortable addressing with a live person.  Thirdly, and perhaps most importantly, I learn about the clinical trials perhaps from someone on a video who is very much like me.  He can be someone with my condition - someone who has gone through a trial, and talk about how his concerns were addressed, what his fears were and what the benefits of participation were.  That, I think, is a much more convincing way to learn about a trial than an ad in a newspaper or even a discussion with a clinical person.  Video can't replace the medical professional, but it sure can get my interest and perhaps trust to make recruitment much easier.”

While the industry’s use of social media for this purpose is not quite there yet, there are some signs that pharmaceutical and biotechnology companies may be trending in that direction. First, a growing number of clinical research organizations (CROs) which help companies plan and manage clinical studies are already using social media tools to recruit prospective clinical trials participants. Second, as Mark reported yesterday, Pfizer launched a YouTube channel called PfizerClinicalTeam last July which presumably would bolster clinical trial recruitment. Unfortunately, as Mark pointed, its most recent video was posted in April, 2010, regarding a new study on schizophrenia. Don’t be surprised if other companies launch social media-focused clinical trials recruitment campaigns in the not too distant future. Like Mark, I believe that social media tools are ideal for this purpose!

In other news, Pfizer, a late entrant to the fledgling pharmaceutical social media space, is showing signs that it is beginning to embrace the social media web. Yesterday, Pfizer and Epocrates announced a collaboration to create an application for the iPhone that gives healthcare providers mobile access to the Pfizer Medical Information Group to obtain medical and science information about Pfizer products or to report adverse events. According to Pfizer, it is creating the app to: “enable easy, direct access to its Medical Information services, via the Epocrates channel, in an effort to enhance the safe and effective use of its medicines, and help improve the quality of patient care.”

Direct access to medical information via mobile devices is growing in popularity among physicians and other healthcare providers because it enables them to get answers on the go without wasting time to fire up a laptop or find a tethered computer to use outside of the clinic.

Despite assertions to the contrary by most pharmaceutical and biotechnology companies, social media tools are ideal vehicles for adverse event reporting and post market drug surveillance activities. Pfizer’s creation of a mobile medical information app coupled with the launch last week of a joint US Food and Drug Administration (FDA) and National Institutes of Health drug safety portal called Safety Reporting Portal (original eh?) suggest that the use of social media tools for online adverse event reporting and drug safety purposes is not too far off. Let’s see what develops over the next year or so after FDA issues regulatory guidance on the use of social media in the life sciences industry.

Until next time...

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

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

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

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

Until next time...

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

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Earlier this week, I attended Advanced Learning Institute’s (ALI) conference “Social Media and Pharma” that was held in Princeton, NJ. The conference was chaired and expertly moderated by Bill Evans, a Senior Vice President and Partner, Digital at Fleishman Hillard. Bill’s insights and command of the social media space were outstanding and helped to keep the conference moving forward and always on point (he also knows a lot about selling old iPhone on EBay—thanks Bill). 

All of the talks that I attended were outstanding and I have to say that the conference was one of the best organized and most focused conferences on the topic of social media and pharma that I attended to date! This is because Bill, a former technology turned business guy, organized the meeting around a conversational “how to” theme rather than allow presenters to talk about their cool Facebook pages, Twitter feeds and blogs. Instead, he asked presenters to share with conference participants their ideas, strategies and experiences associated with implementation of their social media campaigns and programs. 

Two of my favorite presentations were delivered by pharma companies; Pfizer and Novo Nordisk. This was somewhat surprising because historically many pharma companies had to be reluctantly forced into the social media fracas.

The Pfizer presentation, “A Common Sense Approach for Integrating Social Media into Your Traditional Communications and Marketing Plans: A Roadmap for Success” was skillfully delivered by Paul Dyer from WCG (the agency that worked with Pfizer on its social media campaign) and Pfizer’s Kate Bird. Paul, who previously worked with social media in the consumer product industry, offered more facts and statistics that I ever knew existed for social media. With this as a backdrop, Kate went on to describe how Pfizer, a late entrant to the social media scene, leveraged this information to create one of the better social media campaigns launched to date by a pharmaceutical company.

The Novo Nordisk presentation, “How to Use Twitter to Deliver Measurable Results For Your Organization” was delivered by Lois Kotkoskie and Ambre Morley was a veritable road map on how to use Twitter to delivered branded messages about pharmaceutical products. For those of you who may not know, Novo Nordisk is the only company to date that has delivered a so-called “branded pharmaceutical tweet” in the Twitterverse. The now infamous tweet about Novo’s diabetes product Levemir s was delivered by race car driver and Novo spokesperson Charlie Kimball.

Despite this bold and unprecedented foray into branded pharmaceutical tweets, Novo hasn’t yet run afoul of regulators at the US Food and Drug Administration (FDA) This is because Ambre, who is a marketing and PR professional, understood early on in the process, that in order to succeed and stay off of FDA’s radar, she would have to work closely her company’s regulatory affairs department. This is where Lois came in; she is a bona fide pharmaceutical regulatory affairs expert who in addition to her understanding of the arcane regulations guiding pharmaceutical advertising, has a well-developed sense of humor (frequently absent in pharmaceutical regulators) and is seemingly less risk-adverse than a majority of her peers.

It was easy to see that Ambre and Lois work very well together (sometimes I thought I was watching an Abbott and Costello comedy routine). Undoubtedly this is the likely reason why Novo’s diabetes-focused Twitter campaign was so well crafted, executed and in the end, successful. The take away lesson from the Novo experience is that pharma marketing and communication professionals interested in designing and implementing regulatory-compliant social media campaigns must include legal and regulatory representatives in the discussion.

Honorable mentions go to the presentations offered by Ken Rashbaum, Doug Levy and Peter Pitts who mainly talked about some of the legal, regulatory and privacy concerns voiced by pharmaceutical companies about the use of social media. An important issue that nobody at the meeting was prepared to discuss was the possible use of social media for pharmaceutical adverse event (AE) reporting. Generally speaking, conference participants were reticent to address this issue because most thought it would be difficult to have meaningful discussion in the absence of any regulatory guidance on this topic.

As many of you may know, the FDA held public hearings on the use of social media for various purposes in the life sciences industry late last fall. At present, it isn’t clear when the agency will issue that much anticipated guidance.

This past week’s “Social Media and Pharma” conference was the second event produced by ALI on this topic. Based on the attendance and enthusiastic response to the meeting, I suspect that ALI may be planning future events on social media and pharma. If this proves to be the case, then I highly recommend that you attend one or more of them!

Until next time...

Good Luck and Good Tweeting!!!!!!!!!!

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Pfizer today announced that it would lay off another 123 workers at its Pearl River, NY manufacturing and R&D site.

The workers in the facility's research and development division will lose their jobs by early July according to a company spokesperson. He added "There may be some additional positions eliminated over the course of 2010, but this is the last major wave that will be announced.”

This brings to 601 the total number of layoffs at the site. The cuts are part of a global restructuring Pfizer announced in November, weeks after acquiring Wyeth Pharmaceuticals. The company has yet to decide the fate of the plant's manufacturing arm. If it is shuttered, that could lead to more layoffs

In other news, lesser known KV Pharma said it would shed 289 workers or 42 percent of its workforce. KV already had reduced its staff from 1,700 in 2008 to about 680 as of Feb. 28. The company recently shut down its generics subsidiary Ethex Corp. after the company pleaded guilty to criminal charges for not disclosing problems with two of its drugs and agreed to pay $27.6 million in fines and restitution.

While the US government and financial analysts claim that the economy is show signs of improvement, the layoffs at pharma and biotech companies continue. Only time will tell if we have truly turned a corner during this economic downturn.

Hat tip to the Pharmalot blog!

Until next time...

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

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The US Food and Drug Administration (FDA) has advised GlaxoSmithKline (GSK) to suspend sale of Rotarix, its rotavirus vaccine, because it may contain porcine circovirus type 1 (PCV-1) DNA sequences. The FDA and the company both found traces of PCV-1 DNA in the vaccine. It is not clear whether whole virus is in the vaccine or just pieces of its DNA. Luckily, PCV-1 isn’t known to cause disease in humans and infants vaccinated with the vaccine are not likely to experience any health or medical issues..

The agency insists that this is a temporary and cautionary suspension of Rotarix sales. FDA officials are advising physicians to use Merck’s RotaTeq rotavirus vaccine instead, which is made using a different method and which shows no evidence of PCV-1 contamination. Merck and GSK have been vigorously competing for market share in the US vaccine marketplace.

Unfortunately, things haven’t been going well for the highly regarded GSK vaccines division in the past few years. First, the company had trouble getting its anti-cervical cancer vaccine, Cervarix approved in the US. And the company just recently announced that it may not seek regulatory approval for Synflorix, a new pneumococcal disease vaccine that was suppose to compete with Pfizer’s  (formerly Wyeth’s) second generation 13-valent pneumococcal vaccine called Prevnar.

This isn’t the first time that animal DNA sequences have been found in human biotechnology products. Last June, Genzyme was forced to shut down one of its biomanufacturing facilities to clean up viral contamination that had been slowing down production of two of its main products, Cerezyme and Fabrazyme. The virus, Vesivirus 2117, is known to interfere with the growth of Chinese hamster ovary (CHO) cells and is believed to have been introduced through a cell culture nutrient. The virus doesn’t infect humans, but the shutdown cost the company millions in revenue and caused shortages of Cerezyme and Fabrazyme.

Because many vaccine and biotechnology products are manufactured in mammalian tissue culture cell lines, detection of non-human viruses these products are neither uncommon nor unprecedented. However, the recent spate of high profile, virally-contaminated vaccines and biologics suggests that biomanufacturers must be more vigilant when it comes to virus removal and microbiological testing from these products.

Until next time…

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

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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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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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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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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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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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Pfizer today announced that it’s looking to increase its sales force in China to 3,200 by the end of next year, up from about 2,300. The company expects to have sales representatives in about 250 Chinese cities by the end of 2011. It presently has a sales presence in about 185 cities. Previously, Pfizer it will cut nearly 20,000 jobs as part of the Wyeth merger. Over the pass several years more than 50,000 US pharma sales reps have lost their jobs.

Eli Lilly said last fall that it would continue to hire in China, even as it cuts jobs in the U.S. and other developed markets. Novartis is also making a big push into China, hiring hundreds of workers and spending $1 billion to expand a research center in Shanghai.

With business tough in developed markets, drug makers are counting on the developing world for growth and are expanding into biotechnology and generic drug manufacturing.

Like it or not, the emerging markets in China, India, Brazil and elsewhere represent a substantial upside whereas markets in the developing world are becoming less profitable. Drug companies, like most other large multinational companies, always will follow the profit stream not matter where it takes them or at what cost to the folks at home.

Until next time...

 Good Luck and Good Job Hunting (Try China, I hear they are looking for sales reps)

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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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It is getting difficult to keep track of the job cuts that are happening almost daily at Pfizer. A quick perusal of the job cuts to date indicate that the company has eliminated about 1200 jobs in the past week; 680 in Pennsylvania, 400 in New Jersey and 116 in Rockland County, NY (where I grew up!). While there is currently a lull in activity, I suspect additional job cuts will be forthcoming in the near future.

Merck earlier announced that it was slashing about 500 jobs in New Jersey which continues the ongoing carnage that the NJ pharmaceutical workforce had to endure over the past three years.

Meanwhile, in New England, Charles River Laboratories International announced that it is suspending operations at its Shrewsbury, MA facility by the middle of this year. Approximately 300 workers will be losing their jobs at the facility that focused on preclinical drug development.

Despite claims that the US economy is improving, life sciences layoffs are continuing and job growth is much slower than expected. While some economists aren’t that surprised, I would be nervous and exploring my options if I was employed at a life sciences company!

Until next time...

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

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Just when you thought that holding on to a job couldn’t get any worse, Pfizer formally announced yesterday that it would be eliminating 680 jobs from a combined workforce of 4,500 at two former Wyeth facilities in Pennsylvania. According to a company spokesperson, 450 of the layoffs would come from Collegeville and 230 from Great Valley. They will take effect March 12. Persons affected by the layoffs will each qualify for a separation package that will include severance payments, continued medical benefits, and help finding a new job via outplacement services.

While some layoffs were expected, they were much greater than some state legislators were led to believe in earlier discussions with Pfizer. And this isn’t likely to be the end of corporate reorganization at Pfizer PA-based facilities. This is because Pfizer is shutting down the Great Valley facility. There is speculation that after this round of layoffs that the 670 remaining Great Valley employees will be transferred to the Collegeville site or other Pfizer locations. And, it is likely that more Pfizer employees will lose their jobs because Pfizer previously announced that it intended to eliminate as many as 15% or 20,000 jobs after its $68 billion acquisition of Wyeth.

Over the past several months, Pfizer, Eli Lilly, AstraZeneca, Johnson & Johnson and GlaxoSmithKline have announced more than 40,000 job cuts which have devastated the pharmaceutical workforces in Pennsylvania, New Jersey and Delaware. 

Until next time...

Good Luck and hmmmmmm...are there any pharmaceutical jobs left to hunt for?

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As part of their licensure requirements, all physicians and other healthcare providers (HCPs) in the US must participate in continuing medical education (CME). CME requirements are established on a state-by-state basis HCPs who fail to meet annual quotas face reprimand, censure and possibly loss of their medical licenses. As you may imagine, CME is a big business and, not surprisingly, there is no dearth of CME content developers and providers. Unfortunately, CME course development costs are high and, despite state mandated licensure requirements, no one seems to want to sponsor or underwrite the CME development programs except drug and devices companies. Obviously, this creates the potential for monumental conflicts of interest mainly because physicians and other HCPs are drug and device company primary customers.

While I don’t profess to be an expert on CME rules and regulation, I know that the rules and regulations that guide CME content development have become increasingly restrictive over the past few years. In the past, drug and devices manufacturers were able to identify relevant product-related topics within certain therapeutic areas, engage a CME provider to create a curriculum and then offer a product-focused program to physicians. Today, drug companies aren’t allowed to create CME program built around specific products. Instead, CME developers compete for grant monies from drug and device manufacturers and are asked to create CME around relevant issues in certain therapeutic areas. Of course, most of the companies that award the grants have products in those therapeutic areas; but i digress. Companies that award the grants cannot participate or influence the content that appears in the CME programs. Of course this is impossible!

For example, several years ago I was working at an agency that received a “grant” from a client that was developing a new treatment for a virus-associated metabolic syndrome. While we weren’t allowed to highlight or suggest specific treatment options we did receive in direct and subliminal guidance (through various company channels) regarding messaging around content development. To that end, while the company wasn’t directly involved in content development, its medical affairs and marketing departments were “aware” of the content that we were developing. While this was appropriate and well within regulatory guidelines, it is not difficult to see that potential conflicts of interest and bias may have existed in this instance.

Over the last year or so, questionable medical writing practices and conflict of interest concerns about CME course development have come under intense scrutiny in the US Congress. Consequently, there have been ongoing and repeated calls to prohibit industry participation in CME content development. While this may be a great idea, if drug companies no longer are allowed underwrite or sponsor CME course development, there isn’t likely to be any CME in the future. And, if there is no CME, physicians and other HCPs won’t be able meet state-mandated CME requirements to maintain their licenses to practice? What a conundrum!

One solution to the problem is to require state governments, the American Medical Association, university medical schools, hospitals and other organizations (insurance companies?) to underwrite CME development costs! After all, these are the entities that require CME for HCPs to retain their licenses. While this is a perfectly logical solution to a vexing problem, don’t expect any of them to step up to the plate anytime soon. The bottom line: drug companies support and underwrite CME because they recognize that it is a viable marketing vehicle—albeit a subtle one—that is certain to improve product awareness and ultimately sales. For example, if Pfizer sponsors a CME program on erectile dysfunction at a high end resort in some exotic locale and, its logo or mention of a grant to develop the curriculum is acknowledged, it is not unreasonable to assume that physicians attending the course may possibly choose to prescribe Viagra over a competitor’s product. To make matters worse, CME sponsors often time help to defer costs of hotel accommodations, provide support for meals, and even sponsor receptions for physicians who attend CME training programs.

I suspect that some of you may be wondering why I am ranting and raving about CME today. Well, there was an article in today’s New York Times about Stanford Medical School receiving an unrestricted, three-year $3.0 million grant from Pfizer to develop unspecified new CME curricula for physicians. Philip Pizzo, MD, dean of Stanford’s medical school lauds this as the beginning of a new age in CME and suggests that Pfizer will have no say on how the grant monies will be spent. 

Dr. Pizzo contends that the “no-strings-attached” provisions of the grant will insure that the new curricula will be devoid of drug industry influence that has permeated CME courses in the past. Stanford plans to set up “unbiased programs” of postgraduate education on the Stanford campus rather than the industry-selected topics of the past that have been presented to rooms full of doctors at hotels and resorts.” While the new grant sounds promising, I wonder whether or not Stanford is going to disclose the amount of research funding it annually receives from Pfizer. Further, will faculty members who receive or previously have received research monies from Pfizer be prohibited from contributing to content development?  The point I want to make is that, despite Stanford’s good intentions and assertions to the contrary, there is no way to insure that there will be no bias or conflicts of interest in the new curriculum that is developed. 

Finally, I don’t think that there is any question that CME is essential to insure that Americans receive the latest and best possible medical treatments that are available. However, to insure farness and no bias, drug makers and device manufacturers should not be allowed to underwrite or participate in CME content development. This activity should be in the purview of not-for-profit entities (that don’t receive drug industry money) and state government agencies. Like it or not, we live in a quid pro quo society and drug and devices companies (like all “for profit” companies) don’t make investments unless there is an anticipated or guaranteed return on the investment!

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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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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After announcing yesterday that it will be reorganizing and closing 6 of 20 R&D sites worldwide, Pfizer/Wyeth announced today that as many as 2000 R&D scientists will lose their jobs. I suspect that others will lose their jobs in the next few months or so.

The Pfizer/Wyeth and Merck Schering Plough mergers signal the beginning of the end of the traditional vertically integrated pharmaceutical business model. It is evident that pharma is shifting away from its almost 100 year focus on R&D and manufacturing to less labor intensive and costly activities like advertising, marketing, sales and distribution—things that drug makers have excelled in the past decade or so. Innovation will likely no longer come from within but from external sources including academia, biotechnology companies and third party vendors including CROs and CMOs.   

While the loss of thousands of R&D scientists will have little impact on the productivity and operations of life sciences companies themselves, it has serious implications for academic institutions that train life sciences graduate students and postdoctoral fellows. In the past, PhD scientists who were unable to find academic jobs too refuge and found gainful employment in the life sciences industry. However, American industrial R&D jobs are becoming harder and harder to find as larger companies continue to outsource those activities, to Asia, South America and Eastern Europe. And, the competition for the remaining jobs is becoming increasingly fierce. Put simply, academic institutions have to begin to realize that we no longer need as many PhD-trained life scientists as we have in the past. At present, there is a glut of PhD life scientists in the US, many of whom can’t find jobs. Perhaps, this should be taken into account before graduate school admissions committees determine the number of new graduate students they will admit next year.

Until next time...

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

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Employees of Pfizer/Wyeth were notified earlier today of impending changes and consolidation that will be taking place at the newly combined company. According to internal sources, Cambridge, MA, Groton, CT and Pearl River, NY will be the main centers of the combined company’s East Coast operations and San Francisco and La Jolla/San Diego CA will represent West Coast operations. In Europe, the research facility in Sandwich, England will be the main R&D center with a network of smaller sites, in locations such as Montreal, Ottawa, Cambridge UK, Aberdeen UK, and Dusseldorf, Germany providing expertise in vaccine production and biomanufacturing. The company’s China R&D Center in Shanghai will remain the focal point of operations in Asia,

There will be substantial reductions in headcount and the company’s R&D footprint. These include:

• The former Pfizer headquarters in New London, CT, which will be consolidated into the nearby Groton, CT site. Functions currently located at New London will be relocated to Groton
• Elimination of all R&D activities at Princeton, NJ; Sanford and the Research Triangle Park, NC; Chazy, NY; Rouses Point and Plattsburgh, NY; Gosport, Slough and Taplow, UK
• R&D activity will be substantially reduced at the Collegeville, PA and Pearl River, NY sites. Pearl River will remain a center for vaccine and biopharmaceutical development

I suspect that many of the employees who will lose their jobs as a result of the consolidation have already been or will be notified shortly of their fates. It is unfortunate that pharmaceutical companies continue to lay off thousands of employees when the US unemployment rate continues to rise and will likely hit 12 to 13 percent before it is all said and done. As expected, the combined company is reducing its US R&D operations and will likely outsource or purchase these activities from external sources. It is not a good time to be an American R&D scientist.

Until next time...

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

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Johnson & Johnson announced today it would eliminate as many as 8,200 jobs, or 7% of its work force, to help the company cope with what it expects will be a slow economic recovery amid damped demand for drugs, medical devices and consumer products. J&J employs about 117, 000 workers globally. While the job cuts will be global, many losing their jobs will be outside of the US. 

J & J joins a growing list of pharmaceutical and life sciences companies that have announced new layoffs. Pfizer Inc., the world’s biggest drugmaker, plans to fire 19,000 workers following its acquisition of Wyeth and had already cut 10,000 positions since 2007. J&J began firing as many as 4,400 employees from its pharmaceutical and stent divisions in late 2007. Finally, Merck recently announced that it will be eliminating 16,000 workers after its merger with Schering Plough closes later this year.

J&J’s announcement is more bad news for New Jersey which is still reeling from the earlier loss of tens of thousands of pharmaceutical and life sciences jobs.

Until next time...

Good Luck and Good Job Hunting (forget New Jersey)

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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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In a previous blog post, I suggested that there was much speculation about whether or not there would be substantial job losses at the various Wyeth sites throughout Pennsylvania after the Wyeth-Pfizer merger closes. As you may recall, company representatives were assuring Pennsylvania legislators that major job cuts and site closure weren’t likely. 

Yesterday, Bernard Poussot, president of Wyeth Pharmaceuticals, sent a message telling employees the company’s Collegeville Headquarters, which employs about 4,000 people, would remain open after the deal closes on October 15, 2009. The fate of employees at other Pennsylvania-based Wyeth facilities remains uncertain.

While this may be good news for some employees at the Collegeville site, it is likely that a substantial number of jobs will be shed after the deal closes. Previously, Pfizer suggested that the combined company intends to shed about 20,000 jobs. I guess the good news is that all 4000 Wyeth employees won’t be losing their jobs!

Until next time...

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

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The Philadelphia Inquirer reported today that Pennsylvania state legislators, spearheading efforts to retain jobs in the state after the $68 billion Pfizer-Wyeth merger closes next month, said they were fairly confident many positions would remain at Wyeth's regional operations in Collegeville, Great Valley and other sites. Wyeth employs about 4,500 people in the region - about 3,600 in Collegeville and 900 in Great Valley and elsewhere.

One legislator told the Inquirer that "Representatives of both Pfizer and Wyeth have continued to assure us that we should not worry and they have continued to listen to the case that we have made for as many jobs as possible remaining in Pennsylvania." Pfizer, which plans to cut about 20,000 of the combined companies' 130,000 jobs, would not comment yesterday on the statement or the job situation in Pennsylvania. Gee, what a surprise!

If I were a betting man, I would say that there will be massive layoffs in Pennsylvania and elsewhere after the deal closes. Don’t be surprised if Wyeth’s Madison, NJ headquarters and its research facilities in Princeton NJ are first to get the ax. Finally, I am now firmly convinced that you can never trust a thing that a politician says.

Until next time...

Good Luck and Good Job Hunting!!!

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The Belgian chemical manufacturer Solvay announced today that it had agreed to sell its pharmaceutical business unit to Abbott Pharmaceuticals for $6.6 billion. By purchasing Solvay, Abbott gains access to emerging markets in Eastern Europe and Asia along with new therapeutic areas, including hormone therapies and vaccines. Solvay's flu vaccine Influvac will give Abbott an entrant in the burgeoning vaccines market, which is currently dominated by European pharmaceutical giants like GlaxoSmithKline and Novartis.

Abbott already holds U.S. marketing rights for Solvay's Trilipix and TriCor, drugs which raise "good" HDL cholesterol while reducing triglycerides and "bad" LDL cholesterol.

Solvay's other top-selling drugs include the Parkinson's disease treatment Duodopa and hormone therapy drugs AndroGel and Duphaston. It is not clear whether or not the Solvay purchase will affect ongoing pharmaceutical operations or staffing decision in the US. However, I suspect that there will be management changes and layoffs in Europe.

In other news, Johnson & Johnson bought an 18 percent stake in Dutch biotechnology company Crucell NV, which is trying to develop a universal flu vaccine, while competitor Merck acquired the rights to sell Australia-based CSL Ltd.'s Afluria flu vaccine in the U.S.

The Solvay deal is the latest in a string of mergers and acquisitions, as cash-rich pharmaceutical companies race to acquire new products amid looming patent expiry on blockbuster drugs. Earlier this year Swiss drugmaker Roche acquired Genentech following similar deals uniting Pfizer Inc. and Wyeth, and Merck & Co. Inc. with Schering-Plough.

Expect more M&A activity in the life sciences sector before year’s end.

Until next time...

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

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Mark Sendak, author of the incisive EyeonFDA blog and social media enthusiast, has been keeping a watchful eye (pun intended) on the growing number of pharmaceutical companies that are adding channels and videos to YouTube. 

On his blog today, Mark reviews several new channels developed by Novartis, Johnson and Johnson, Teva, Boehringer Ingelheim and AstraZeneca. While a growing number of pharmaceutical companies continue to add new channels on YouTube, Mark contends that the “success of these channels has varied greatly and several companies have obviously developed the channels without any idea of what they would like to do with them and some of the channels show obvious signs of neglect.”

To learn more about pharma’s incursion on YouTube, read Mark’s post!

Until next time...

Good Luck and Good Video Watching

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Pfizer, the world’s largest drug maker, announced on Thursday that it is unveiling a new program that will let people who have lost their jobs and health insurance to keep taking Pfizer medications — for free, and for up to a year. The company will provide more than 70 of its prescription drugs ranging from Viagra to Lipitor at no costs to unemployed and uninsured Americans who lost their jobs since Jan. 1 and have been taking Pfizer drugs for me than three months. It is not clear how much Pfizer will spend on the program and whether or not costs will be capped.

The announcement comes amid massive job losses caused by the recession and a campaign in Washington to rein in health care costs and extend coverage. The move could earn Pfizer some goodwill in that debate after long being a target of critics of drug industry prices and sales practices. The program also likely will help keep those patients loyal to Pfizer brands. Don't be surprised if other pharmaceutical companies announce similar program over the next few weeks.

Pfizer and the rest of the drug industry wants is trying to have a voice in the debate over how to overhaul the U.S. health care system, partly by joining in a pledge this week to help hold down inflation of health costs. In the mean time, drug companies have been raising prices on their drugs, partly to offset declines in revenue as the global recession reduces the number of prescriptions people can afford to fill.

Pfizer ought to be commended on the program and its concern for the health and well being of unemployed and uninsured Americans. However, it is important to point out that this is little more than a high profile, marketing campaign designed to improve the image of drug makers. More important, it is the first public acknowledgement that drug makers are willing to engage legislators in discussions about how to reform healthcare to reduce costs and cut expenditures. 

What really is at stake here is whether or not the US government will begin regulating drug prices as part of a comprehensive healthcare reform package. As many of you may know, the US government, unlike most other governments in the world, cannot negotiate or set prescription drugs prices. Not surprisingly, the US prescription drug market is the largest and most profitable in the world. It will be interesting to see how the US healthcare reform discussion unfolds—clearly a lot is at stake for the American prescription drug industry.

Until next time...

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

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Twitter, which is currently de rigueur in social media circles, is emerging as one of the most powerful branding and marketing social media tool that has been developed to date.   While other industries are already exploiting Twitter’s powerful marketing reach (to hawk their wares), drug makers have been reluctant to adopt Twitter and most other forms of social media. Industry analysts and company insiders contend that pharma’s reluctance to adopt social media can be attributed to the US Food and Drug Administration’s (FDA) lack of guidance on its use for promotional purposes. At present, it is anybody’s guess when this guidance may be issued, if ever.

Nevertheless, as always, there are a few daring companies willing to “boldly go where no pharma company has gone before”—in this case—Twitter! These companies include Boehringer Ingelheim (BI), Astra Zeneca, Novartis and Pfizer. According to a post on the Advance Market WoRx blog, BI is leading the way among pharma company Twitterers, with 679 following, 745 followers and 47 tweets. AstraZenecaUS has 136 following, 440 followers and 22 tweets. Pfizer has 351 following, 462 followers and 48 tweets.  Novartis has 0 following, 681 followers and 40 tweets (I guess Novartis has a thing” against following people).

Unlike its fellow pharma Twitters, BI—which began using Twitter in November 2008—actually uses it as an interactive and conversational microblogging platform (as it was intended). The other pharma company Twitters use it almost exclusively “as a one-way PR feed” says Ellen Hoenig Carlson at Advance Market WoRx. According to a post on the Pharmafocus website, "Boehringer has incorporated Twitter into its wider communications strategy and is using the site regularly to engage its stakeholders. In addition to posting press releases, BI uses Twitter to recommend web-based information about therapeutic areas and articles that its followers might find interesting or useful. To keep its finger on the pulse of the Twitterverse, BI uses media scanning programs to help monitor online conversations and responds quickly to join in or start up Twitter conversations.”

Kudos to Boehringer for recognizing Twitter’s potential to communicate with patients, physicians and other interested parties. I hope that more pharmaceutical companies begin to use Twitter and other forms of social media to engage and improve communications with their stakeholders.

Until next time...

Good Luck and Good Twittering (or should it be Tweeting?) 

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Since 2007, approximately 80,000 pharmaceutical jobs have been eliminated. The recent consolidation in the industry, e.g., Merck-Schering, Pfizer-Wyeth and Roche-Genentech suggests that many more life sciences jobs will be lost over the next year or so. Typically, to avoid law suits and possible discrimination claims, most companies will layoff a mixture of experienced and entry level employees that cover the racial, religious and age spectra. For those of you who may not know, Americans who are 40 and older constitute a “protected class of employees.” In other words, companies that layoff employees cannot disproportionately give pink slips to employees 40 years of age or older. This law was enacted because older employees typically have higher salaries and have accrued more benefits and vacation time than their more junior counterparts and eliminating them can drastically cut costs. While most companies are careful to layoff a mixture of junior and senior employees during large layoffs, a quick perusal of the demographics of employees who lose their jobs reveals that many of them are older, more experienced workers. Sacrificing a few entry level employees (to prevent any red flags) is worth it to the accountants who charged with cutting costs and orchestrating large corporate layoffs.

Unlike consumer goods, pharmaceutical and biotechnology drug development is arcane, complex and may take up to 15 years to complete. There are many “go” or “no go” decisions that must be made during the drug development process. Typically, these decisions are rendered by experienced employees who have been “down the road” many times before and are able to recognize the oft-time nuanced attributes of successful drug candidates. Without the benefit of these employee and their experiences, drug companies may struggle to make the “right decisions” for new products being developed. Also, the loss of experienced employees can disrupt the flow of essential “corporate knowledge” to entry level and more junior employees. This is important because— while most entry level and junior employees are academically and technically qualified—it usually takes them years (under the tutelage of mentors and senior employees) to understand a company’s best practices. Put simply, the unrelenting loss of experienced pharmaceutical workers can alter the standing or dominance of pharmaceutical companies in certain therapeutic areas. While massive layoffs of experienced pharmaceutical employees bolster drug stock prices in the short term, the long term effects of these layoffs on the overall health of the pharmaceutical industry remains uncertain.

Jeff Kindler, Pfizer’s CEO, mentioned yesterday during a CNBC interview, that eight Wyeth senior executives will keep their jobs after the Pfizer-Wyeth deal closes later this year. Not surprisingly, he failed to mention how many “rank and file” employees of the combined company would keep their jobs after the merger. Don’t be shocked when Pfizer-Wyeth announces massive layoffs after the deal closes—Pfizer’s stock price has fallen 21% since it announced the Wyeth acquisition late last fall.

Until next time....

Good Luck and Good Job Hunting!!!

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Rumors are rife that Novartis is going to purchase Lexington, MA-based Cubist for $1.6 billion. Wall Street analysts are speculating that Novartis may announce the deal as early as Monday.

Cubist manufactures Cubicin (daptomycin), one of only a handful of new antibiotics brought to market in the past 20 years that is effective against many infections caused by Gram-positive bacteria, most notably methicillin-resistant Staphylococcus aureus (MRSA). The company is developing new lipopeptide antibiotics similar to Cubicin and also has an active anti-viral drug discovery program.

Over the past 10 years, big pharma companies largely abandoned antibiotic research and placed all discovery efforts in the hands of only a few smaller public companies and startups. Cubist is the only independent biopharmaceutical company that successfully brought a new antibiotic to market. 

Novartis’ possible acquisition of Cubist signals, that at least one major pharmaceutical company sees opportunities and upside in the antibiotic drug discovery market. Several years ago, Pfizer acquired another antibiotic discovery company, Vicuron (formerly Versicor) but to date the acquisition has not yielded any new antibiotics. While Novartis’ acquisition of Cubist is yet another sign of consolidation that is taking place in the life sciences sector, it may bolster new efforts in the antibacterial drug discovery area. Unlike Cubist, Novartis has enough money and marketing muscle to increase Cubin sales and develop some of the exciting new molecular entities in Cubist’s drug development pipeline.

Until next time…..

Good Luck and Good Job Hunting!!!!

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In the wake of last week’s Pfizer-Wyeth M&A feeding frenzy, I suspect that most analysts were hoping that this week would be a little quieter. Unfortunately for many pharmaceutical company employees, this week may be shaping up to be almost as nerve-wracking as last week!and declared that it was on the hunt for a merger or acquisition partner. A ll of the usual suspects have been cited as possibilities. They include: Bristol Myers Squibb (Plavix, Erbitux, Orencia Abilify) , Amgen (EPO, Aranesp, Neupogen, Neulasta and Enbrel), Biogen-Idec (Avonex, Tsyabri and Rituxan) (Actavis (generics) Ratiopharm (generics) and Crucell (vaccines). The hands on favorite and most likely target would be Bristol Myers Squibb because the two companies co-market Plavix, their top selling drug that is due to lose patent protection in the next year or so. That said, in this environment anything can happen. 

In other news, GlaxoSmithKline announced that it will be cutting 6,000 jobs later this week when the company puts out financial results. The company began reorganizing itself in 2007 and will continue to do over the next few years to deal with generic encroachment on several of its top selling drugs. Glaxo employs about 100,000 people worldwide. Analysts suspect that many of the job cuts will occur in the UK and that sales rep may be hit the hardest in this latest round of layoffs.

Until next time…

 Good Luck and Good Job Hunting!!!!!

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Talk about a rough week. First, on Monday, Pfizer announced that it was acquiring Wyeth, a move that is expected to result in the loss of 8,000 to 10,000 jobs if the deal is approved. This was followed on Wednesday by an announcement from Abbott Laboratories indicating hat it was laying off about 200 sales representatives because of regulatory delays for its12 hour-formulation of its pain drug Vicodin. Finally, on Thursday, AstraZeneca announced that it will cut another 7,400 jobs worldwide by 2013 (bringing the total number of expected layoffs to 15,000). Also on Thursday, Sepracor, the maker of the sleeping pill Lunesta, announced that it will cut 20% of its permanent work force (530 jobs) and 410 contract sales representatives (even though the company announced a profit).

Suffice it to say it has been a tough week for pharmaceutical company employees. I hope that next week is better.

Until next time…

Good Luck and errrrrr Good Job Hunting????????

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The ink hasn’t had time to try on the deal sheet and Pfizer already has announced what the impact of its acquisition of Wyeth will have on the combined company. Here’s what to expect: Pfizer will shed at least 19,000 jobs from it newly combined work force of 128,000 employees; it will slash its stock dividend by 50%; and it will take a $2.3 billion charge to settle a federal investigation over off label promotion of its former pain drug Bextra. 

The combined company will be run by Pfizer’s CEO, Jeff Kindler, who joined Pfizer in 2006 after serving as legal counsel for McDonald’s. Bernard Poussot who became Wyeth’s CEO a little over a year ago will depart the company. As I mentioned in a post yesterday, Pfizer and Wyeth had been in talks for over a year before the deal was consummated. If the deal had closed last year, Mr. Poussot would have garnered a $38 million dollar severance package that included cash, pension, health benefits and other entitlements. But, because Wyeth’s board changed its compensation package for its CEO on January 1, he will only be entitled to a severance package of only $18.3 million. Not bad for a guy who ran the company for little over a year!

Other fallout from the deal includes: increased consolidation or purchase of cash-poor biotechnology companies—that will result in more layoffs and continue to reduce the life sciences workforce in the US— and the loss of a potential biotech dealmaker (Wyeth) that was aggressively pursuing M&A strategies and licensing opportunities with smaller, struggling biopharmaceutical companies. Most Wall Street analysts agree that the debt taken on by Pfizer to purchase Wyeth will prevent the company from participating in any new major acquisitions in the foreseeable future.

While the deal may ultimately benefit Pfizer, it certainly won’t help to improve the overall, short term health of the pharmaceutical and biotechnology industries.

Until next time…

Good Luck and Good Job Hunting (I hear that they are hiring on the West Coast)

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I believe in free enterprise and that publicly-traded companies ought to be able to buy one another if a deal makes sense. In any other financial market, Pfizer’s impending acquisition of Wyeth would be a noteworthy event but not extraordinary. However, we are living in unprecedented and uncertain financial times and Pfizer’s possible purchase of Wyeth has serious implications for American taxpayers.

As you may recall, the US government has pumped hundreds of billions of dollars into American banks so that they remain “solvent.” This was done to unfreeze credit markets and to purportedly provide relief, albeit indirectly, to American taxpayers many of whom are in financial trouble. However, the government’s infusion of TARP money didn’t unfreeze the credit markets and banks are still reluctant to lend to one another or to small business owners and consumers who need financing to keep their business and homes.

The Pfizer-Wyeth deal began about a year ago when Pfizer’s CEO floated the idea of a merger or acquisition. Negotiations between the two companies were on and off over the past year mostly because Pfizer and Wyeth couldn’t agree on an acceptable purchase price. The financial meltdown of last October changed all that and it became economically feasible for Pfizer to purchase Wyeth at a sharply discounted price.  However, one of the missing variables in the equation (that might kill the deal) was the availability of credit to complete the transaction. Because US banks are currently flush with TARP cash (because they stopped lending) and the Pfizer-Wyeth deal represents a safe deal with a substantial financial upside, it was not surprising that four of the largest US banks were willing to finance the deal.

According to the NY Times, “Pfizer’s bid is being financed by four banks that received bailout money: Goldman Sachs, JP Morgan Chase, Citigroup and Bank of America.” Ironically, last week the US government agreed to give Citigroup and Bank of America an additional TARP infusion to prevent them from “failing.” Amazingly, these very same banks (that have been teetering on the brink of insolvency for the past several months) can find the cash (taxpayer money) to finance Pfizer’s purchase of Wyeth. And, what can the American taxpayers expect to receive in return for investing in the deal—massive job layoffs— if Pfizer’s past purchases of Warner Lambert and Pharmacia are used as harbingers of things to come.

In better financial times, these layoffs would be noteworthy but not insurmountable jobs—there were always jobs at rival pharmaceutical companies and smaller biotechnology companies. However, over the past three years, the pharmaceutical industry has shed over 160,000 jobs and the biotechnology industry, the usual refuge for former pharma employees, has also layed off tens of thousands employees. Put simply, there is no longer a place for these highly skilled and experienced pharmaceutical employees to go to seek employment.

Wyeth shareholders and the banks will undoubtedly benefit financially from the impending deal. On the other hand, while Pfizer may garner some short term benefits from the Wyeth purchase, I think the ROI from the deal will be nominal over the long haul. Ironically, the people who stand to lose the most from the deal are the very same people who made the deal possible—the American taxpayers!  Imagine how you might feel if a deal made on your behalf using your hard-earned money resulted in your eventual unemployment!

Until next time…

Good Luck and Good Job Hunting!!!!!

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Pfizer's board of directors voted on Sunday evening  to acquire Wyeth for $65 billion.  While this may help to assuage some of Pfizer's short term financial problems, like the loss of  Lipitor in 2011,the deal will not help the combined company in the long run. 

The deal will undoubtedly lead to massive layoffs at both Pfizer and Wyeth--a time when our economy cannot afford much more job loss.  Further, it will diminish competition, reduce the need for more scientists and ultimately diminish America's standing in the life sciences. 

If I were a Pfizer or Wyeth employee the first thing that I would do on Monday morning would be: update my resume, contact as many  recruiters as I can and find a new job before the layoffs begin. I think the era of severance packages is over!

Until next time... 

Good Luck and Good Job Hunting!!!

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Pfizer is the largest pharmaceutical company in the world. It was able to garner that distinction by going on a decade-long buying spree that began in the mid 1990s. To date, Pfizer has acquired Warner Lambert, Pharmacia and a host of smaller specialty pharmaceutical and biotechnology companies. Despite these acquisitions, which yielded top selling blockbuster drugs like Lipitor and Celebrex, Pfizer’s stock has never performed up to analyst’s expectations. In fact, while it’s smaller and more nimble pharmaceutical competitor’s stock prices were soaring, Pfizer’s stock price was either flat or falling. While conventional wisdoms suggest that “bigger is always better” this has proven not to be the case when companies, like Pfizer, attempt to win greater market share through mergers and acquisition and also loss sight of their core business.

In my opinion, Pfizer’s acquisition of Warner Lambert in the mid 1990s was a well executed, strategic move—the transaction gave Pfizer rights to Lipitor, currently the world’s top selling prescription drug. At that time, Pfizer’s internal drug discovery pipeline was essentially running on empty and it needed a blockbuster to insure its future growth. Despite the benefits of the Warner Lambert deal, it took Pfizer many years and hundreds of millions of dollars to fully integrate the two companies into a fully functional one.

Several years later, Pfizer acquired Pharmacia to gain access to Celebrex, a Cox-2 inhibitor that had the potential of becoming a blockbuster drug to treat inflammation and chronic pain. Unfortunately, Pfizer’s ROI on Celebrex hit a sales-stopping road block when the safety of Cox-2 inhibitors was called into question after Merck withdraw its Cox-2 inhibitor, Vioxx from the market in 2005. While Pfizer directly benefited from Celebrex sales, it again took the company many years, at great expense, to fully integrate Pharmacia into Pfizer’s day-to-day operations.

During its decade long expansion, Pfizer’s internal drug discovery programs were largely ignored and had begun to fail largely because of management’s inexorable focus on acquiring blockbuster drugs rather than developing them internally. In the early 2000s, recognizing that blockbuster drugs were becoming harder to purchase, the company bet its financial future on a new cholesterol-lowering drug called torcetrapib (which, by the way, was developed by Pfizer scientists). The buzz surrounding torcetrapib—a potential blockbuster drug that was expected to replace Lipitor—reached a fever pitch in 2006 as Pfizer’s stock price soared. Unfortunately, Pfizer was forced to abandoned clinical development of torcetrapib in late 2006 because it exhibited potential life-threatening side effects in pivotal Phase 3 clinical trials This failure, coupled with the impending loss of  patent protection for several of its top selling drugs, most notably Lipitor, has placed Pfizer in its current precarious financial situation.

Like many of its competitors, Pfizer believes that biotechnology is the “next big thing” and its executives have publicly disclosed their intentions to get into “protein-based therapeutics.” While this strategy may represent a way for Pfizer to correct its current downward trajectory, the company, as a whole, lacks the requisite biopharmaceutical experience and expertise to commercially compete in this space. To obviate this, Pfizer has hinted that it would consider purchasing a large biotechnology company or a pharmaceutical company that has biotechnology products on the market.  Enter Wyeth—another pharmaceutical company that is trying to reinvent itself as a biopharmaceutical company. However, unlike Pfizer, Wyeth markets and sells two successful biotechnology products—Enbrel, a treatment for rheumatoid and psoriatic arthritis and Prevnar a blockbuster anti-pneumococcal vaccine. However, it is important to note that neither Enbrel nor Prevnar were developed at Wyeth. Further, while Wyeth has achieved commercial success with both Enbrel and Prevnar, several of its non-biotechnology drugs have recently hit regulatory snags and their future approval is uncertain.

On the surface, a Pfizer-Wyeth merger may make sense—both companies are struggling, Pfizer needs an entrée into biotech and Wyeth has marketed biotechnology products and biomanufacturing capability. However, a closer examination of the deal reveals some major flaws. First, Wyeth’s internal biotechnology discovery pipeline is sparse (although it does have a few, niche protein-based products in early stage clinical development). While Enbrel sales are increasing and consistently have topped $1 billion in annual sales in recent years, Wyeth only owns the non-US rights to Enbrel (Amgen owns the US rights). Second, Prevnar is coming off patent soon and GlaxoSmithKline (GSK) has developed a competing vaccine that is expected perform as well or better than Wyeth’s next generation version of Prevnar. Finally, Prevnar has been a huge money maker for Wyeth because there are currently no other approved pneumococcal vaccines on the market. The introduction of GSK’s competing vaccine will undoubtedly have a negative impact on the sale of Prevnar and its successor. If neither company has strong internal drug discovery pipelines and both lack sufficient expertise in biopharmaceutical product development, why are Pfizer and Wyeth actively engaged in M&A discussions?

For the past several months, rumors have been circulating that Pfizer might acquire Amgen. While a Pfizer-Amgen deal makes more sense to me that a Pfizer-Wyeth one, I don’t think that acquiring another large pharmaceutical company is in the best interests of Pfizer shareholders (they are still paying for the past two mergers!). That said, if Pfizer does acquire Wyeth, the combined entity will still hold the distinction of being the world’s largest pharmaceutical company—at least there is that!

Until next time...

Good Luck and Good Job Hunting (hope that a merger doesn’t take place—there will be layoffs!)

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While the domino theory was incorrect when it came to the spread of communism during the Cold War, there may be a kernel of truth to it when it is applied to today’s pharmaceutical industry. On Tuesday, Pfizer announced that it would lay off 800 researchers. Not to be outdone by Pfizer, Roche announced today that it plans to lay off about 780 workers over the next two to three years because of “worsening economic conditions.”

After spending the last decade or so associated with the pharmaceutical industry, one thing that I have learned is that there isn’t a single company that I can think of that wants to be the first to do anything. However, when a pharma company makes a bold move, the others are very quick to follow because they “don’t want to be perceived as not being “cutting edge” or keeping pace with their competitors. To that end, the domino theory may warrant some further investigation when it comes to day-to-day operations of big pharma.

Until next time,

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

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I received an e-message from a reader who alerted me about new information and rumors that are swirling about the layoffs announced yesterday by Pfizer.  For more info, check out the post at the Daily Anchor.

Seems like other things may be brewing at Pfizer.

Until next time...

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

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Long rumored, Pfizer announced yesterday that it will eliminate another 800 research jobs outside of its six core therapeutic areas: cancer, pain, inflammation, diabetes, Alzheimer’s disease and schizophrenia. The new cuts represent 5 to 8 percent of Pfizer’s approximately 10,000 researchers worldwide. According to a company spokesperson, the company will continue to evaluate its current staffing to make decisions that are consistent with its future goals. In short, expect more layoffs to occur in the near future.

Industry analysts expect additional cuts to occur in R&D and Pfizer’s dwindling sales force. To date, Pfizer has eliminated about 10,000 jobs, mostly in R&D and sales. Pfizer became the world’s largest pharmaceutical after going on a 12 year buying spree that began in 1996 after its acquisition of Warner Lambert, the company that developed the blockbuster anti-cholesterol drug Lipitor. The company currently employs about 85,000 people worldwide.

Wall Street rewarded Pfizer’s decision to layoff more scientists by pushing its stock share price up 1.3% yesterday. Rewarding a company for eliminating one of its most important and valuable assets has never made sense to me. But, then again, I am a scientist not an MBA-toting Wall Street analyst—what do I know?

Until next time…

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

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Pfizer announced today that it will eliminate almost 1,000 jobs in France through layoffs or voluntary departures. Gerard Bouquet, vice-president of Pfizer France, announced that "This new organization will take effect from Dec. 1, 2009 and there will be no forced layoffs before that date.” The cuts will affect Pfizer’s sales force and at it Paris-based headquarters.

Today’s announcement comes just a few days after Rod MacKenzie, Pfizer’s worldwide head of discovery research told reporters “Given the complexity of the changes within research, I have concluded that we will not be able to provide that clarity [for the layoffs] or communicate them by the end of the year." While it appears that there may some confusion regarding American workers, this is clearly not the case for Pfizer’s European employees.

Until next time…

Good Luck and Good Job Hunting

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Over the past few weeks, the blogosphere was rife with rumors and speculation that Pfizer would be laying off additional R&D personnel in December. However, it seems that the layoffs have been postponed and nobody at Pfizer seems to know when they will take place. Conventional wisdom suggests that job cuts will likely take place sometime after the holidays, probably in mid -January, 09.

Rod MacKenzie, Pfizer’s worldwide head of discovery research told reporters “Given the complexity of the changes within research, I have concluded that we will not be able to provide that clarity [for the layoffs] or communicate them by the end of the year." I suspect that he knows who will be getting pink slips but is reluctant to make the announcement until early next year because it would look awful if Pfizer lets people go right before the holiday season. 

Call me crazy, but I don’t think that publicizing lay offs (to be determined later) is good for employee productivity and morale. I have no doubt that rumors about the impending layoffs have been circulating at Pfizer for months. Unfortunately for Pfizer, one or more of its employees leaked the information and company executives are in damage control and spin modes. The inability of Pfizer executives to control internal information flow is just another example of why many industry analysts believe that Pfizer grew too quickly over the past decade. Nevertheless, hundreds and perhaps thousands of Pfizer employees will lose their jobs in the not so distant future.

Until next time…

Good Luck and Good Job Hunting (forget Groton, CT)

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Pfizer may announce new job cuts by the end of next month as the company tries to curb spending before cheaper generic versions of its top- selling drug Lipitor flood the market in 2010. The cuts will likely take place in sales and marketing—Pfizer has cut more than 14, 000 jobs since 2007. 

Aren’t you glad that you didn’t take me up on that land deal in Florida?

Until next time…

Good Luck and Hang On!!!!!!!!!!!

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Astra Zeneca announced today that it would cut 1400 jobs and close several manufacturing facilities worldwide. According to a post on the Pharmalot blog “about 600 full-time jobs will be lost in Sweden as packaging operations are expanded in Wuxi, China. The cuts will come on top of the 7,600 positions the drugmaker plans to eliminate by 2010. The plant closings will occur in Spain, Belgium and Sweden by 2013. Manufacturing jobs will also be trimmed in Sweden and the UK as production is shifted to lower-cost countries in emerging markets.”

On Tuesday Wyeth disclosed that it was eliminating 70 positions at its Pearl River, New York, facility (which employs 3,200 workers, 118 employees at its Rouses Point facility in upstate New York that employs 725 people work, and 124 jobs at its Sanford, North Carolina manufacturing facility. Ironically, as more and more US workers are laid off, many big pharma companies like Merck, Pfizer and GlaxoSmithKline are expanding operations at their research facilities in India. In fact, Merck is doubling its headcount from 800 to 1,600 employees at its research facility in India that was opened a little over a year ago.

Until next time…

Good Luck and Keep on Looking!!!!

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The Pharmalot blog reported today that Pfizer will likely layoff large numbers of R&D personnel over the next few weeks and months. This should not come as a surprise to Pfizer employees because the company recently announced that it would eliminate research in certain therapeutic areas including heart disease and obesity as part of a global reorganization plan. According to the company, the reorganization is expected to be completed by year’s end and operational in 2009. Inside sources say that the job losses should be significant and far reaching.

In other news, BioJobBlog learned today that Bristol Myers Squibb plans to announce company-wide layoffs by December 1, 2008. As previously reported by BioJobBlog, BMS has been quietly downsizing since last spring because of the impending patent expiry (in 2011) of its blockbuster anticlotting drug Plavix. BMS, unlike Pfizer, has been extremely circumspect about its impending layoffs which is causing a great deal of anxiety among its employees. The recent sale of ImClone, BMS’s partner for the cancer drug Erbitux, to Eli Lilly will undoubtedly contribute to additional layoffs at BMS in the future. Currently, Erbitux is BMS’s top selling biopharmaceutical product.

It goes without saying that it is not a good time to be a pharma employee. Unfortunately, as the old adage goes “things are likely to get worse before they get better”. 

Until next time…

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

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Pfizer announced earlier today that it was going to cut R&D jobs and abandon its research efforts in the areas of cardiovascular diseases, cholesterol management, osteoporosis, anemia and liver and muscle diseases. The company plans to refocus it drug development in five therapeutic areas including Alzheimer’s; diabetes; immune disorders and inflammation; cancer; pain; and mental illness, including schizophrenia. Also, the company will continue its work on anti-thrombotic agents to prevent blood clots.

The job cuts and refocusing are part of a previously announced plan to cut about $2 billion dollars from Pfizer’s operating budget. Over the past 15 years, Pfizer has gone on an unprecedented buying spree in an attempt to acquire blockbuster drugs and bolster its flagging internal drug development pipeline. Unfortunately, the gamble has not paid off and Pfizer must now attempt to reinvent itself to restore shareholder value and instill investor confidence. 

Unlike many of its competitors, Pfizer failed to invest in and capitalize on early opportunities in the biotechnology industry. The company has been trying to play catch up ever since. To that end, over the past year or so, Pfizer invested in or purchased several small biopharmaceutical companies to demonstrate its commitment to biotechnology.  It may be “too little too late!” Unfortunately, because of a lack of vision and foresight by company executives, many Pfizer employees will have to pay the ultimate price of losing their jobs as the US falls deeper into recession.

Hat tip to Pharmalot and the WSJ Health Blog.

Until next time…

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

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Pfizer announced today that it would withdraw marketing application being considered at FDA and the European Medicines Agency (EMEA) for Dalbavancin an antibiotic it was developing for complicated skin infections caused by bacteria including methicillin-resistant Staphylococcus aureus (MRSA).

Pfizer acquired Dalbavancin after it purchased California-based Vicuron Pharmaceuticals for $1.9 billion in 2005. At that time, Vicuron had filed an NDA with FDA and had expected approval for the novel antibiotic. Instead, after acquiring Vicuron, Pfizer received an approvable letter from FDA that requested additional studies before the agency would approve the drug. Based on the agency’s comments, Pfizer decided to withdraw the original US and European applications filed by Vicuron and conduct addition Phase III clinical trials for the complicated skin and soft tissue infection and pediatric indications. I suspect that results from these trials will determine whether Pfizer files new applications with FDA and EMEA for Dalbavancin.

For those of you who may not know, Vicuron Pharmaceuticals was formerly called Versicor, a company founded by Eric Gordon, Mickey Gorman and others. In 1996, I was recruited to interview for a Vice President of Biology position at the company.  At that time, Versicor had about 15 employees — Eric was CEO and Mickey was a consultant.  Although Eric, Mickey and I became fast friends, I didn’t get the job (they never hired anybody for the position). 

Both Eric and Mickey left Versicor a couple of years later. Eric went on to start Sunesis, a very successful Bay area oncology company and Mickey retired to his home in Key West, FL. From time to time, I would run into Eric at BIO meetings and Mickey and I would meet up at my all time favorite Vietnamese restaurant (Hy Vong) in Little Havana in Miami, FL. Eric has since retired after 30 years in the pharma/biotech biz and Mickey unfortunately passed away from cancer in the early 2000s.

After meeting Eric and Mickey, I knew that Versicor would be a success one day—the $1.9 billion that Pfizer paid for Vicuron tends to validate that notion. While I didn’t benefit financially from Versicor, I was lucky and fortunate to meet two, really smart, fascinating and genuine individuals who helped me to establish my credibility in the biopharmaceutical industry.  As the saying goes “Money isn’t everything!”

Hat tip to Ed at Pharmalot.

Until next time…

Good Luck and Good Job Hunting!!!!!

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A little over a year ago, Bristol-Myers Squibb (BMS) launched its “productivity transformation initiative” (PTI) designed to “transform” the company into a next generation biopharma leader. As most of you may already know, PTI is corporate speak for layoffs and downsizing.

The PTI was largely in response to impending loss of patent protection in 2011 of its blockbuster Plavix, an anti-thrombosis drug that BMS co-markets with Sanofi Aventis. While BMS has a deep and innovative drug pipeline, the likelihood that the company will be able to replace Plavix revenues with one of its investigational drugs is remote.

To make matters worse, late last week, one of Plavix’s likely successors, an investigational anti-clotting drug called apixaban (being co-developed with Pfizer) failed to meet its primary clinical endpoints in a pivotal Phase III clinical trial called Advance 1 which was designed to evaluate the drug for prevention of venous thromboembolism in patients undergoing total knee replacement.  The 3,195-patient study compared apixaban, an oral Factor Xa inhibitor given at a dose of 2.5 mg, twice daily, to twice-daily 30mg injections of Sanofi-Aventis’ Lovenox (enoxaparin). This late stage clinical failure prompted the company to announce that it would no longer seek approval of apixaban in 2009 as previously planned.

Early this week, BMS ratcheted up the PTI and imposed a total hiring freeze for all permanent employees, consultants and leased workers (contractors). Previously, vacated permanent or temporary positions could be refilled if appropriate, qualified job candidates were identified. Finally, the company announced today that it would permanently ground its corporate fleet of jets that was operating out of Mercer County Airport in Trenton, NJ. According to an article in my local paper, the Trenton Times, BMS plans to sell four aircraft and layoff about 32 employees, mostly pilots and mechanics. 

Despite all of the other PTI initiatives implemented to date, the decision to sell all of its corporate jets sends a clear signal to stakeholders that BMS truly “means business”! I guess Jim Cornelius and other BMS executives will have to book commercial flights or take Amtrak to out-of-town meetings for the foreseeable future. That said, I doubt that Jim and others will be driving or taking the train to meetings in New York City or Washington—the corporate helicopter fleet is still operating!!!!!

Until next time….

Good Luck and Good Job Hunting (forget BMS)!!!!!!!

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Pfizer announced today that is it closing a manufacturing facility in Cork Ireland.  Approximately 180 people will lose their jobs. Pfizer tried to sell the plant but was unable to find a buyer. The Cork plant will officially be closed sometime in 2009.  Another of Pfizer’s five Irish manufacturing facilities located in Ringaskiddy is also on the block. That facility employs about 300 people. Pfizer cites the 2006 failure of torcetrapib, an experimental cholesterol drug as the reason for the plant closings.

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Yesterday Pfizer announced that it would layoff 275 employees at its manufacturing facility in Kalamazoo County in Michigan. Not to be out done by big pharma, generics manufacturer Perrigo Co. said today that it is going to create 400 new jobs in the western Michigan town of Allegan. According to published reports, Perrigo plans to invest $10.5 million in its Allegan, MI headquarters and manufacturing facility in an expansion that is projected to generate 99 new jobs within a year and 400 others over five years. A Michigan Economic Development Corp’s analysis suggests that the Perrigo expansion could generate up to 1,039 jobs in Michigan by 2020

A Perrigo spokesperson said that as it has done with past jobs cuts in Kalamazoo, the company will recruit the Pfizer personnel losing their jobs. This is good news for the folks who were laid off by Pfizer yesterday. However, when you do the math (275-99), the will be a net loss of 176 pharmaceutical jobs in Western Michigan by year’s end. Although Perrigo said that another 300 jobs will be created over the next five years, I wouldn’t count on many jobs being added until the US economy finds its way out of its current recession.

Hat tip to Pharmalot for the heads up!

Until next ….

Good Luck and Good Job Hunting (Michigan may be better than I thought)!!!!!

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Pfizer is at it again. The company announced today that it will cut 275 jobs from its manufacturing operations in Kalamazoo County before the end of the year. The cut will reduce the company’s total employee roster to about 2,500 at the Portage, MI site.

Pfizer has been steadily streamlining and downsizing operations in Michigan ever since it inherited several Michigan-based sites after it acquired Pharmacia in 2002.

Not surprisingly, a company spokesman said “We operate in a highly competitive and constantly changing environment, and we have to adapt to that.'' Easy for him to say—he still has a job. 

The announcement comes on the heels of a rumor circulating last week that some Pfizer employees at its Croton R&D facility may lose their jobs next fall.

Until next time….

Good Luck and Good Job Hunting (avoid Michigan)!!!!!!!!!!

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According to apost at Pharmalot, rumor has it that Pfizer will lay off a number of chemists at its main R&D facility in Groton, Connecticut as early as next Fall The rumor supposedly began at an R&D blog run by a former Pfizer employee (always a reliable source for inside information). 

M y colleague Ed Silverman who runs Pharmalot contacted Pfizer about the rumor and received this response “A leading R&D organization must evolve, continue to build on its strengths, capture competitive advantage wherever possible and be realistic about what it will take to return Pfizer to growth. What I can assure you is that if and when there are organizational changes, those decisions are never taken lightly. Our guiding principle is that colleagues hear about important Pfizer news from company leadership first and are treated with the utmost respect.” In other words, Pfizer will likely be laying off more employees in the very near future.

Hat tip to Ed!

Until next time…

Good Luck, Good Job Hunting and Happy 4^th of July!!!!!

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As many of you may know, Ranbaxy was involved in a bitter patent dispute with Pfizer over Lipitor, Pfizer’s blockbuster multibillion, dollar anti LDL-cholesterol drug. Ranbaxy was challenging the validity of Pfizer’s intellectual property estate for Lipitor which would have extended patent protection for the drug until 2013 or longer. The patent dispute began after Ranbaxy filled an ANDA with the US Food and Drug Administration to sell generic Lipitor after uncontested Lipitor patents expire in early 2010.

Conventional wisdom suggested that Pfizer would ultimately lose the patent dispute and that Ranbaxy would be able to immediately flood the market with a much cheaper generic version of Lipitor. This would have an enormous negative impact on Pfizer’s financial stability and its future (Lipitor had $12.8 billion in sales in 2007). Nevertheless, untilDaiicho-Sankyo announced its intention to acquire Ranbaxy last week, Pfizer was willing to gamble and run the risk of losing the lawsuit. Apparently, Ranbaxy impending sale was enough of an impetus for Pfizer to settle the patent dispute which has grown increasingly acrimonious over the past year or so.

According to agreement (which needs to be approved by the US Federal Trade Commission), Pfizer was able to get Ranbaxy  to agree to delay the release of generic Lipitor until November 2011 — up to 20 months later than many analysts had been expecting (some insiders believed that generic Lipitor could reach the market as early as March 2010). Further, as part of the agreement, Pfizer will allow Ranbaxy to sell its version of Lipitor in Australia, Canada, Belgium, Germany, Italy, the Netherlands and Sweden two to four months before Liptor’s patents expire. This is likely the sweet part of the deal for Ranbaxy because all of the above mentioned markets are top sellers for anti-cholesterol drugs. Finally, because Ranbaxy was the first to file an ANDA for generic Lipitor with the FDA, it will get 6 months of market exclusivity guaranteed (in the Hatch Waxman Act) to a generic manufacturer that is first to file for generic production of a brand name drug nearing patent expiry.   However, after quickly perusing the terms of the deal, I think that it more closely resembles an authorized generics deal rather than a “true” competitive generics launch.

Currently, Lipitor costs about $2.50 to $3 a day. Analysts predict that Ranbaxy can sell its generic Lipitor for about 75 cents to $1 a day, or as low as 10 cents a day at some discount pharmacies. The potential drastic price reduction coupled with Daiichi-Sankyo’s intention to purchase Ranbaxy (which would have provided Ranbaxy with more money underwrite and press on with IP lawsuit, it what I believe forced Pfizer’s hand to act as quickly as it did to settle the suit. The deal, if approved, allows Pfizer to dodge a near fatal financial bullet and will provide it with a potentially lucrative revenue stream from it authorized generics deal that it struck with Ranbaxy. 

Nevertheless, given the financial stakes associated with the Lipitor franchise, it may make more sense for Pfizer to purchase Ranbaxy rather than enter into the pending deal. Also, a Ranbaxy purchase would allow Pfizer to enter the biologics and biotechnology fields—something that Pfizer executives have been talking about publicly to insure the company’s future. Like most other pharmaceutical generics manufacturers, Ranbaxy has active research programs on biosimilar and other biotechnology products. If I was driving the boat at Pfizer I would offer Ranbaxy a lucrative counteroffer to block its sale to Daiichi-Sankyo. I don’t know—the deal just makes sense to me. That said, not many recruiters have been calling me about CEO jobs lately!!!!!!

Until next time…

Good Luck and Good Job Hunting!!!!

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Rumor has it that Pfizer may offer a counteroffer to acquire India-based generics manufacturer Ranbaxy. As you may recall, Japan’s Daiichi Sankyo agreed earlier in the week to pay about $4.6 billion for a controlling interest in Ranbaxy. According to reports many analysts expect Pfizer to attempt to queer to the Daiichi-Ranbaxy deal because “it is battling Ranbaxy in about 18 countries on patent rights of Lipitor, the largest selling cholesterol drug in the world. Lipitor has annual sales of $13 billion. In most countries the patent on the drug will expire starting 2011.”  Ranbaxy has won favorable court decisions on Lipitor in many countries including in the US, the largest drug market in the world, which accounts for 28 per cent of the global generic market estimated at $72 billion.

I tend to agree with the pundits. Pfizer has a lousy pipeline and its recent clinical trial record is horrendous. Consequently, the company must hang on (as long as possible and at any cost) to its blockbuster brands to avoid financial ruin.

Stay tuned for late-breaking news and updates!

Until next time…

Good Luck and Good Job Hunting!!!!!

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Brand name pharmaceutical and biotechnology companies have been quietly spending millions to lobby Congress for changes in US patent law. Specifically, these companies want to overhaul the intellectual property rules dealing with the doctrine of “inequitable conduct”. When a company or individual engages in inequitable conduct, it means that the company or individual has misrepresented or concealed information with the intent to deceive the US Patent and Trademark Office (USPTO). In such cases, a federal judge has the legal authority to void the patent and declare that it is unenforceable. Not surprisingly, brand-name drug companies are lobbying Congress to eliminate or curtail inequitable conduct penalties. 

According to the New York Times, in the last 15 years the US Court of Appeals for the Federal Circuit (which handles appellate patent litigation) have ruled in the affirmative on 40 cases of inequitable conduct–14 of which involved pharmaceutical or healthcare companies. Similar rulings have been issued by federal district judges in an indeterminate number of cases that were not appealed (and never reached the Federal Circuit court). The article contends that some drug makers knowingly submitted false statements to the USPTO, inaccurately described experiments in patent applications or concealed information (usually prior art) that contradicted their claims. In one high profile case, the appeals court ruled that the Danish drug maker Novo Nordisk failed to disclose that it had not performed an experiment described in a patent application for human growth hormone. In another notable case, the court contends that Pharmacia (now Pfizer) used an “inaccurate and misleading” affidavit to win a patent for a new glaucoma drug.  Personally, I am aware of several instances in which companies willfully and knowingly failed to disclose prior art in patent applications that were ultimately approved.

Those of us in the biz know that patents are valuable commodities and that the financial stakes surrounding patent estates and intellectual properly are extremely high. A robust patent estate can either make or break a company. Nevertheless, in my opinion, if a company (or individual) cheats by falsifying, concealing or omitting pertinent information in a patent application, they ought to be penalized for it.  As one former USPTO commissioner, who served under George HW Bush puts it: “Patents can be very valuable. There are strong incentives to want to get them. Cheating occurs from time to time. The inequitable conduct doctrine says that if you cheated to get a patent, you should not be able to enforce it.”

Brand name drug manufacturers contend that generic drug makers routinely attack their patents by accusing them of inequitable conduct, whether they are guilty or not. Further, they claim that unwarranted and endless patent litigation impinges on their ability to discover and bring new drugs to market. Consequently, brand name drug markers argue that the inequitable conduct doctrine should be eliminated from US patent law. Not surprisingly, this would seriously hinder or curtail the ability of generic drug manufacturers to bring their products to market—something that brand name drug makers desperately want to protect their multibillion dollars drug franchises from generic encroachment.

The number of patent applications submitted to the USPTO has doubled in the past 10 years and more than tripled since 1987. According to Jon Dudas, the current undersecretary of commerce for intellectual property “We are getting more and more unpatentable ideas and worse and worse quality applications”. Historically, the annual number of patents that are allowed (approved) ranges from 62 to 72%. After reaching a high of 72% in 2000, it dropped to 43% in the first quarter of 2008. These data suggest that, the probability of getting new patents allowed is diminishing. This is making brand name drug companies anxious and extremely competitive when it comes to patent applications. And, when competition increases, it is not uncommon for companies and individual to resort to unorthodox (and sometimes overtly unethical or illegal methods) to insure success. In my opinion, the doctrine of inequitable conduct and the penalties associated with it are what keep illegal and unethical behaviors in check. With this in mind, I think it would be extremely unwise for Congress to eliminate or severely curtail the penalties for inequitable conduct.

Based on the small number of inequitable conduct cases that have reached the Federal Circuit, it appears that the current system is working the way it was designed to function. This begs the question: “Why fix something that isn’t broken? “ Oh wait, this debate isn’t really about ethics or legality–it is about making money–silly me!

Until next time….

Good Luck and Good Job Hunting (try intellectual property law)!!!!!!!!

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Pfizer the world’s largest and least innovative pharmaceutical company  announced yesterday that its profits dropped by 18% last year. The company attributed the loss to reductions in the sale of its blockbuster anti-cholesterol drug Lipitor, which is slated to lose patent protection in the next few years.

Pfizer, which has about $25 billion in cash, has been on something of a buying spree the past couple of years. The company is desperately trying get into biotechnology (too little, too late?) and believes, as it always has, that the best way to enter a new therapeutic area is to buy its way into it! To that end, Pfizer has already purchased two “biotech” companies in 2007 (more purchases are likely on the way) and entered into financially-lucrative, long term research collaborations with several others. Although this strategy has previously worked for Pfizer in the short term, it has proved to be financially disastrous for the company in the long term. Nevertheless, Pfizer said it still expects earnings this year to grow about 11%, due largely to a cost-cutting program that has eliminated 25,000 jobs, or 23% of its work force since 2004.

Until Pfizer executives realize that a robust internal drug discovery and development program is the key to success, Pfizer will continue to be the world’s biggest pharmaceutical company with a constantly flagging stock price.

Until next time….

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

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Has it really been 10 years since the launch of Viagra, the first drug that was approved to treat erectile dysfunction (ED)?  Why it seems like just yesterday. For those of you who don’t know, Pfizer was originally developing Viagra as a treatment for cardiovascular disease (it increases blood flow). However, members of the Viagra clinical development teams quickly observed Viagra’s unmistakable erectogenic potential and understood the impact that it would have on male sexual function for years to come.

Before Viagra’s launch in 1998, impotence, (the term previously used to describe what is now known as ED) was rarely discussed or mentioned by anyone, including many physicians. Now, with the advent of Viagra, Levitra and Cialis ED has become a part of the American lexicon.  So-called tough guys like Bob Dole to NFL players are no longer ashamed to mention that they suffer from ED now that they can take a pill to overcome the condition. All kidding aside, Viagra has helped many men with conditions ranging from diabetes, atherosclerosis to prostrate cancer. But, there is one question that I have. “Are there really that many men who suffer with ED to account for the roughly $6.0 billion per year that is spent on Viagra and related medications? 

Anyway, Happy Birthday Viagra! Maybe the little blue guy’s birthday can get a “rise” out of Pfizer’s stock today–sssshhhhhhh, let’s not put too much pressure on Viagra, it may interfere with its performance!

Until next time....

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

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Cambridge, MA-based Alkermes announced today that it is restructuring its operations following the termination by Eli Lilly and Company of its inhalable AIR Insulin program (Alkermes manufactured the inhaler delivery device). The company is reducing its workforce by approximately 150 employees and closing its AIR commercial manufacturing facility in Chelsea, MA. The company is taking these actions based on its current expectations of the financial impact of Lilly's termination of the AIR Insulin program.

The job cuts, effective this week, represent almost 18% of Alkermes’ total workforce. Employees affected by the restructuring will be eligible for a severance package that includes severance pay, continuation of benefits and outplacement services. The company expects cost savings from the restructuring in the range of $15 million to $20 million in fiscal 2009.

In other news from across the pond, the trade group, the Association of the British Pharmaceutical Industry (ABPI), reported today that the UK pharmaceutical industry lost about 8.000 pharmaceutical jobs or about 10% of its workforce over the past three years. The ABPI asserts that there is a direct link between job cuts and changes to the British government’s pricing mechanisms for medicines. A spokesperson for the group said “Every time a new PPRS (Pharmaceutical Price Regulation Scheme) comes into force there is a decline in the number of jobs”. Not surprisingly, the group is urging the government to not make any changes in the PPRS.

The UK pharmaceutical workforce has taken a number of big hits of late– Pfizer recently closed a manufacturing plant in Kent, while British drug makers AstraZeneca and GlaxoSmithKline both announced substantial global job cuts many of which were located in Britain.

Until next time….

Good Luck and Good Job Hunting!!!!

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Maybe Pfizer executives ought to ask their doctors for Zoloft prescriptions to deal with the compulsive buying spree that they have been on for past 6 months or so. After acquiring after Encysive Pharmaceuticals just two weeks ago,  Pfizer announced plans to acquire Serenex, a privately-held biotechnology company that specializes in oncology.  Pfizer also acquired Copely Pharmaceuticals last November.

 No financial details of the deal were disclosed but Pfizer is acquiring the rights to SNX-5422, an oral heat shock protein 90 inhibitor which is currently in Phase I trials for the potential treatment of solid tumors and hematological cancers. The company is also acquiring Serenex’ proprietary drug discovery technology and “extensive small molecule Hsp90 inhibitor compound library”, which has potential uses to treat cancer, inflammatory and neurodegenerative diseases.

Surprisingly absent from the deal are the rights to SNX-1012, Serenex’ lead compound, which is for treatment of oral mucositis in cancer patients. It is scheduled to complete Phase II trials in mid-2008 and researchers working on the drug will form part of a new company that is to be spun off and owned by the current shareholders of Serenex.

I guess the adage “You can’t teach old dogs new tricks” is apt for Pfizer. I guess they still haven’t learned that bigger is always better!!! Go figure.

Until next time

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

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 that 660 jobs will be lost at a Pfizer manufacturing facility in Terre Haute, Ind., a result of Pfizer Inc.'s decision to stop production of its inhaled insulin product Exubera.

Nat Ricciardi, president of Pfizer Global Manufacturing, announced Pfizer's decision to cut staff in Terra Haute because the company did not have another use for the specialized Indiana-based production facility.

Facility workers were told of the decision on Monday morning and that told layoffs would begin in March. The production facility employs about 800 workers in total and a majority of the affected employees are those hired within the last five years to produce Exubera. The remaining 140 workers will support the company's sterile manufacturing operation that included antibiotic production.

When the company announced plans in October to discontinue Exubera, it also said about 60 jobs would be lost at its manufacturing plant in Portage, Ind. They are among a total off 200 jobs the company has said will be cut here before the end of this year.

A Pfizer spokesperson said the company is "committed to providing whatever assistance our colleagues need, including internal job postings, job search tools, career and retirement counseling and severance benefits for those who leave the company." It appears that the Midwest is starting to feel pain associated with contraction of the pharmaceutical industry.

Until next time….

Good Luck and Good Job Hunting (forget the Midwest)!!!!!!!!!!

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The Danish drug maker Novo Nordisk announced today that it was halting further clinical development of its inhalable insulin product called AERx. AERx was in Phase 3 clinical testing as a short-term diabetes treatment. In a press release the company stated that it was halting development of its inhaled insulin compound because the drug was "unlikely to offer significant clinical or convenience benefits" versus current diabetes treatments.” AERx joins Exubera (Nektar Therapeutics/ Pfizer) on the inhalable insulin scrap heap. This leavesEli Lilly and Alkermes’ IR insulin system as the only inhalable short-acting diabetes treatment in Phase 3 clinical development.

Interestingly, Novo didn't say that it was giving up on developing inhalable insulins— only that it was halting its current late-stage AERx program. The company did announce that it plans to pursue a Glucagon_Like Protein (GLP-1) inhalable diabetes treatment which is similar to a product being developed by California-based MannKind. Its product in Phase 1 clinical testing. Unlike Nektar, which partnered with Pfizer to develop Exubera, MannKind, a small startup, is developing its inhalable insulin product alone. Novo also disclosed plans to develop a longer-acting injectable form of insulin which would eliminate the need for daily injections by patients with diabetes.

In theory, inhalable insulins make sense—many people hate daily injections. That said, inhalable insulins may create other problems that obviate their usefulness as alternatives to daily insulin injections-just ask Pfizer and Nektar about that!

Until next time….

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

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Pfizer Inc. said Tuesday it will buy privately-held biotechnology company CovX in a move to augment its own internal pipeline of biotechnology products. CovX’s expertise lies in developing long-acting, peptide-based biotherapeutic drugs.

La Jolla, Calif.-based CovX has already generated one early-stage diabetes candidate and two early-stage cancer treatment candidates, Pfizer said. It will operate as part of Pfizer's Biotherapeutic and Bioinnovation Center in California.

According to Pfizer CEO Jeffry Kindler, “The acquisition of CovX is a further step in Pfizer's strategy to acquire and identify new product candidates that we can put into development, leveraging both Pfizer's expertise and that of world-class scientists charged with discovering and bringing in new compounds.” The truth is: that Pfizer hasn’t seen a deal that it could not resist!

A Pfizer spokesperson said CovX scientists will remain with the company. That is exactly what Pfizer told Warner Lambert and Pharmacia employees after those companies were purchased.
If I was working at CovX I would be updating my resume–just in case

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I hate to be the bearer of bad news (don’t kill the messenger) but 2007 has been rife with corporate downsizing and job layoffs. According to a post at Fierce Biotech, jobs cuts were primarily driven by “Concerns about patent expirations, falling sales due to drug safety concerns, redundancy from acquisitions and a general need to streamline operations”. The companies that have “laid-off” the most workers are:  

1. Pfizer-10,000 
2. Astra Zeneca-7,600 
3. Bayer-6,100 
4. Johnson & Johnson
5. 5,000 Amgen-2,600

Companies that did not make the list but have quietly been laying off workers or freezing jobs include GlaxoSmithKline, Merck, Eli Lilly and Bristol-Myers Squibb.

It is not a good time to be looking for a job in the pharma or biotech industries. That said, there is always hope and let’s “hope” that 2008 is a better year for both industries.

Until next time….

Good Luck (you will need it) and Good Job Hunting!

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I guess the old adage that “You can’t teach old dogs new tricks” applies to Pfizer’s decision to buy Coley Pharmaceuticals. Why isn’t it obvious to Pfizer executives that buying companies is easy, but integrating them into a a pre-existing corporate culture is difficult, time consuming and not cost effective.

Yes, Coley is sort of a “biotechnology company” and, as Pfizer has publicly stated, it wants to get into biotech in a big way. And yes, Pfizer and Coley have had a long standing research and business partnership. But, I am not sure that Coley is going to bring any real value to Pfizer. According to Jeffrey Kindler, Pfizer’s CEO, “This acquisition is an important component of Pfizer's vaccine strategy and reflects our commitment to research new and more effective vaccines to prevent infectious diseases and to treat cancers and other debilitating conditions". Coley has been around for many years but recently re-invented itself as a biotechnology company. A quick perusal of its products indicates that is sells a vaccine adjuvant and has several drug candidates in its pipeline (with only one in early stage clinical development). Although this appears to be a quick fix to “jump start” Pfizer’s biotechnology push, I do not think the acquisition will convince business analysts and Pfizer stakeholders that Coley will allow Pfizer to boldly go where the company has not gone before!

I wish Pfizer luck! I also hope that Coley employees are updating their resumes after today’s announcement.

Until next time…

Good Luck and Good Job Hunting!!!!!

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I was reading a post about the Exubera deal that Pfizer cut with Nektar the other day and I stumbled upon this tidbit–“The two companies will continue to jointly develop an inhaled formulation of PEGylated recombinant human growth hormone (rHGH) to treat growth problems”.

For those of you who may not know, protein PEGylation–developed about 30 years ago by Frank Davis and Abe Abuchowski at Rutgers University– involves chemically attaching polyethylene glycol (PEG) to proteins. PEGylated proteins are less immunogenic and circulate longer in the bloodstream than native, unPEGylated proteins. Protein PEGylation has revolutionized the biopharmaceutical industry because it reduces immunological side effects, improves clinical efficacy and enhances patient compliance (by reducing the number of injections that are required) for many protein-based drugs. Several companies including Schering Plough, Roche and Amgen have used protein PEGylation to create multibillion blockbuster a year biotechnology products like PEG-Intron, Pegasys and Neulasta.

Like most protein-based products, rHGH needs to be injected daily to achieve its desired clinical effects. At present, there are no fewer than 8 rHGH products on the market that are used to treat pediatric and adult growth hormone deficiencies. The holy grail of the growth hormone market is to develop a sustained-release version of rHGH so that daily injections are no longer necessary. To that end, several companies, including Nektar, have developed PEGylated versions of rHGH which are in various stages of clinical development. These products should hit the markets in Europe and the US within the next few years.

Although Pfizer is in the rHGH biz, it is puzzling (to me) why any company would consider developing an inhaled form of PEGylated rHGH –given all of the regulatory hurdles and exhorbitant development costs-when an injectable form of PEGylated rHGH would be far superior and offer greater patient benefits than any of the currently marketed rHGH products? Maybe I am missing something here. That said, the larger question is: Why hasn’t Pfizer learned that the inhaled protein market is a dicey one at best?  Maybe that's why Pfizer is still Pfizer!

Until next time….

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

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Nobody knows how much Pfizer spent on developing and promoting Exubera, but the company took a $2.8 million charge yesterday to cover costs associated with the drug–making it one of the most expensive failures in the history of the pharmaceutical industry.

Despite its status as the world’s largest pharmaceutical company, things are not going well for Pfizer. The company has already consolidated operations and laid off thousands of workers a result of the torcetrapib mess. Further, the ripple effect that the Exubera debacle may have on Nektar and other companies like Eli Lilly that are developing similar inhalable insulin products is unknown at present. 

I do not think that the pharmaceutical and biotechnology industries can withstand much more bad news. Pfizer’s  ongoing bad news, coupled with the GlaxoSmithKline’s Avandia mess and Amgen’s epoetin woes suggest that it may be a good time to load up  your portfolio with already “cheap” pharmaceutical and biotechnology stocks—there is only one way for these stocks to go—and that is up!

Until next time….

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

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Pfizer announced earlier this week

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This morning, Jacob Goldstein at the Wall Street Journal's healthblog, suggested that Wyeth may be an attractive buying opportunity for beleaguered pharmaceutical giant Pfizer.  He based this possibility on a note that he received from Credit Suisse analyst Catherine Arnold, in which she posited that Wyeth's strong pipeline and plummeting stock price (due to recent regulatory setbacks) may  make it attractive as a buyout opportunity for pipeline-challenged Pfizer. 

Call me crazy but I think the assertion is ridiculous and simply an overt attempt by Mr. Goldstein to boost readership for the WSJ's healthblog.  In my opinion, Pfizer has been mired in a downward financial spiral ever since it acquired Warner Lambert (for Lipitor) in the late 1990s.  I think by now that Pfizer executives have learned the lesson that bringing companies with contrasting corporate cultures under a single roof  (regardless of monetary inducements and a financial upside), is more costly and challenging than it appears to be "on paper"

Although Mr. Goldstein's assertion is speculative, I do not  think it is appropriate to start fresh rumors about  possible corporate buyouts that could affect an already erratic and destabilized stock market. That said, I think that bloggers have an ethical responsibility  to consider the impact that their posts have on everyday folks before they begin to speculate on possible corporate mergers or buyouts. Imagine the effects that these rumors could have on the daily lives of already demoralized Wyeth and Pfizer employees! 

Until next time....

Good Luck and Good Job Hunting!!!!!

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