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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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