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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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I am old enough to remember when the artificial heart was invented and used to extend the life of Barney Clark, a dentist in Seattle, WA. It was a phenomenal accomplishment back in the day. So, it seemed appropriate to me that Robert Jarvik, the guy who invented the artificial heart, appeared in Pfizer’s Lipitor ads as a spokesperson to promote heart health. However, a Congressional committee examining consumer drug advertising has questioned whether the Lipitor ads may have misrepresented Dr. Jarvik and his credentials to promote the drug.

Although Dr. Jarvik has a medical degree, he is not a cardiologist nor is he licensed to practice medicine! Further, one television ads depicts Dr. Jarvik as an accomplished rower but the ad used a body double for him and, as it turns out, he does not even row! To make matters worse, a former colleague of Jarvik contends that he is not the actual inventor of the artificial heart. He suggested that the distinction belongs to Jarvik’s mentor Willem J. Kolff and his associate Tetsuzo Akutsu at the University of Utah. Go figure! Despite the firestorm, Pfizer continues to air the television ad ( I saw it just a few days ago).

Pfizer has spent more than $258 million advertising Lipitor (a cholesterol-lowering statin) since January 2006, most of it on the Jarvik campaign in an attempt to protect Lipitor from generic competition. Lipitor is the world’s best selling drug and generated $12.7 billion in revenues in 2007. While Lipitor has patent protection until 2010, some patients have already switched to a generic version of a competing cholesterol drug Zocor. According to published reports Pfizer agreed to pay Jarvik about $1.35 million under a two-year contract that expires next month. I think it is safe to assume that Jarvik will not appear in any future Lipitor ads.

As many of you may know, drug companies FDA is not required to review direct-to-consumer ads before they are aired to the American public. While some companies request FDA review of their promotional materials before they are used in advertising campaigns, the vast majority of companies do not. Unfortunately, because of this regulatory loophole, direct-to-consumer advertising has turned into something of a cat and mouse game–there are only consequences and penalties if you get caught misrepresenting or not fully disclosing information about your products.

In my opinion, Pfizer’s misrepresentation of Jarvik’s credentials (and Jarvik’s complicity) is unethical and unconscionable. More importantly, it demonstrates how easily and willing companies are to “bend the truth” to preserve blockbuster drug franchises that generate billions of dollars in annual revenues. I think that what Pfizer did was wrong and shameful. The company should be fined and sanctioned for the Lipitor campaign. That said, it is likely that the size of the fine levied by FDA will pale in comparison to Lipitor revenues generated by the Jarvik campaign. I believe that it is time for Congress and FDA close the loopholes in current direct-to-consumer advertising regulations–the safety and health of the American public depends on it!

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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According to an article in the Ann Arbor News, hundreds of Pfizer employees and their guests gathered at Eastern Michigan University's Convocation Center late last week for a good-bye party sponsored by the company.

The party included a live band parodying popular songs with Pfizer-themed material, with the participation of site director David Canter, and a retrospective video documenting change at the Ann Arbor site since it was built in the late 1950s.

Nobody was crying in their beer or anything like that," said a seven-year employee. "There was good food, nice music ... people were there just to have a nice time with their colleagues. ... It's hard to be bitter when you had such great people to work with." Gee, with such loyal employees, you wonder why Pfizer shut down the facility?

I guess business is business–at least Pfizer Ann Arbor ex-employees know that the company appreciated them a lot and that there are no hard feelings.

Until next time…

Good Luck and Good Job Hunting (I hear Ann Arbor is nice)

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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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Pfizer said on Tuesday it will eliminate another 40 workers from factories in Puerto Rico. Pfizer closed a plant in Arecibo, Puerto Rico in 2005 and last year announced 210 layoffs in the U.S. Caribbean island territory

As pointed out by Ed Silverman over at Pharmalot, Puerto Rico has long been a manufacturing hub for US pharmaceutical companies. Over the past 30 years, pharmaceutical manufacturing has accounted for a quarter of the island’s gross domestic product and currently employs about 20,000 Puerto Rican citizens.

Over the past few years, companies like Watson Pharmaceuticals (generics), GlaxoSmithKline, Teva (generics), Bristol Myers Squibb and Schering Plough have either closed or will close manufacturing facilities on the Island. These closings were somewhat surprising because the Puerto Rican workforce is one of the best pharmaceutical manufacturing workforces in the world. That said, US pharmaceutical companies are looking elsewhere to produce their drugs because of rising wages, changing tax structures and the high cost of electricity (supplied by oil-fired power plants) on the island. Further, over the past decade, there have been ongoing compliance and quality assurance problems at many of the shuttered manufacturing facilities. Officials from these companies explained that it was less costly to shut down and move operations elsewhere rather than modernize the plants and bring them into regulatory compliance.

Despite these recent facility closings, the island’s pharmaceutical manufacturing industry still produces 13 of 20 best selling drugs in the US. However that number will likely continue to dwindle over the next few years. Many companies that have closed or are considering closing production facilities are moving operations to Asian destinations like Singapore, China, Thailand (and even Vietnam) where there are trained workforces, lower wages and cost structures and many people speak English.

Unlike most pharmaceutical companies, Amgen, Abbot and Lilly recently built or relocated biomanufacturing operations to Puerto Rico. Because of a trained workforce and Puerto Rico’s ongoing familiarity with FDA regulatory requirements, I suspect that other biotechnology and specialty pharmaceutical companies will consider establishing biomanufacturing facilities in Puerto Rico– pharma’s loss may well be biotech’s gain!!!!

Until next time….

Good Luck 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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First, there was the torcetrapib catastrophe and now the Exubera debacle. Pfizer announced late yesterday that it would stop selling Exubera, the first approved inhaled insulin product, less than two years after its approval. Despite heavy promotion by Pfizer, Exubera sales were tiny, with prescriptions amounting to less than 1% of the multi-billion dollar insulin market.

Once heralded as a potential blockbuster drug by industry analysts, Exubera was plagued with questions about its safety, efficacy, convenience and cost. The bottom line is that it worked no better than injected insulin and, results from clinical trials showed that Exubera could decrease patients’ breathing ability. This coupled with the appearance of the delivery device, which resembled a bong (not that there is anything wrong with that), contributed to the inability of Exubera to gain acceptance among patients and physicians.

Exubera was originally developed by Nektar, a small publicly traded California-based biotechnology company that specializes in inhalation technology and protein delivery systems that include PEGylation. Pfizer bought the marketing rights from Nektar and assumed responsibility for clinical development of Exubera.

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 that is will establish a biotechnology research and development center in the Bay area in the near future. I think that it 's about time that the world’s largest pharmaceutical company finally realized that its future growth and success no longer lie exclusively in the realm of small molecules–duh!!!! I ask–“Where have Pfizer executives been and what have they been doing for the past 20 years"? I guess they subscribe to the old adage; “better late, than never”. Tell that to all of the right-sized Pfizer employees who lost their jobs in the past few years.

Maybe Pfizer is on-track and will get it right this time. One can only hope!

Until next time….

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

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Can anything else go wrong at Pfizer? Unfortunately for Pfizer employees, the answer is yes. Pfizer and FDA announced late last week that they found detectable levels of the mutagen/carcinogen ethyl methanesulfonate (EMS) in Viracept, the company’s flagship anti-HIV medication. EMS has long been known to be a potent mutagen and carcinogen. I can attest to the mutagenic potential of EMS, because in my former life as a bench scientist I routinely used it to generate point mutations in the bacteria that I was working with.

Pfizer and FDA agreed not to recall the drug in the US because the quantity of EMS found was “low”. However, Roche, the company that sells Viracept in Europe, did recall the drug (slightly higher levels of EMS were found in the European version of Viracept). Predictably, FDA cautioned that although there are no human data, EMS has been shown to cause mutations, tumors and birth defects in animals and is a "potential human carcinogen. Not surprisingly, Pfizer advises children and pregnant women not to start the drug, although children already taking it may continue (really?).
How EMS got into both the US and European versions of the drug remains a mystery. If I had to guess, it is likely that there are significant quality control and quality assurance issues at the manufacturing plant(s) that produces Viracept. Alternatively, the EMS may have always been present in Viracept (as a contaminant or chemical by product) but nobody thought to look for it until recently. According to one report, “Pfizer is working with the FDA to prospectively limit EMS levels in Viracept, while still considering the immediate needs of patients on therapy. This is nonsense. There are other protease inhibitors that HIV-infected patients can try before they continue to take EMS-tainted Viracept. I think that Pfizer should voluntarily recall Viracept and eliminate all traces of EMS before it is reintroduced to the US and European markets!

Until next time….

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

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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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