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The regulatory problems at Wyeth continue. The US Food and Drug Agency announced that it issued an approvable letter for Tygacil (Wyeth’s tetracycline-like antibiotic) to treat community acquired pneumonia (CAP). Apparently, FDA regulators want more data on the effectiveness and safety of Tygacil in severe cases of CAP and additional information on possible liver toxicity.

Tygacil, an intravenously administered antibiotic, won FDA approval in 2005 to treat adults with complicated intra-abdominal infections and complicated skin and skin-structure infections. Tygacil had about $138 million in sales last year; falling far short of the projected $500-$800 million in annual sales that it was expected to yield when it was first brought to market. If Wyeth gains approval for CAP, expect Tygacil sales to soar.

In other regulatory news, FDA granted Wyeth “fast-track approval” for a new version of its market-leading pediatric pneumococcal vaccine called Prevnar. The new 13-valent formulation will provide protection against 13 different pneumococcal serotypes. The older version only provided protection against 7 serotypes. Wyeth hopes to complete its filing for pediatric use of the new Prevnar vaccine in early 2009. Prevnar is Wyeth’s second-leading product with sales of about $2.5 billion in 2007.  

The new Prevnar vaccine will likely go head-to-head with GlaxoSmithKline’s new 10-valent pneumococcal vaccine  called Synflorix^Tm which is in late stage clinical development and is currently being reviewed for marketing approval in the EU. Unlike Wyeth’s vaccine, Synflorix^Tm  was found to be effective in protecting against otitis media (ear infections) caused by Haemophilus influenzae.

Until next time,

Good Luck and Good Job Hunting (avoid Collegeville, PA)!!!!!!!!

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I want to thank my esteemed colleague, Ed Silverman at Pharmalot, for the heads up on this post.  As part of Wyeth’s asset realignment program dubbed “Project Impact”, the company announced today that it would cut another 1,200 jobs at “all facilities in all capacities.”  Meanwhile, late last Friday 141 people at Wyeth’s Pearl River, NY, facility were laid off. Most of the jobs that were cut were in manufacturing and R&D. Of interest, last Friday was also Bob Essner’s last day as Wyeth’s CEO (he will continue as Chairman through December 31, 2008). For those of you who may be interested, Bob’s total compensation package in 2007 was about $20 million (his base salary was a paltry $1.73 million).

The most recent layoffs were made as part of the drug maker’s previously announced plan to cut up to 10 percent of its global workforce of 50,000 by 2011. Wyeth executives contend that Project Impact is warranted because of increased generic drug competition and a weak product pipeline. As you may recall, Wyeth previously laid off 1,240 sales reps late last month due to sagging sales of several of its consumer and pharmaceutical brands.

These new layoffs couldn’t come at a worst time for Wyeth employees. For those of you who still have jobs at the company, I highly recommend that you begin to explore alternative career opportunities. It is going to be a long and difficult ride!

Until next time… 

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

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According to a post on the Wall Street Journal Health blog, Wyeth announced today that it is laying off about 1,200 marketing and sales representatives who helped support Protonix, its blockbuster heartburn and acid reflux medication. The job cuts are part of a previously announced “asset reallocation plan” that is designed to reduce the size of the company’s workforce by about 5% this year, and by 10% over the next three years.

The company employees about 50,000 people worldwide with roughly half of them in the U.S.  Like some of its competitors, Wyeth is facing stiff generic competition for several products that are slated to lose patent protection over the next couple of years and recently has had trouble getting many of its new drugs approved by the US Food and Drug Administration.

Until next time….

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

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Is it luck or good planning that has prompted many pharmaceutical and biotechnology companies to set up manufacturing and research operations in Ireland? In my opinion, the recent Irish pharma and biotech explosion has little to do with luck and everything to do with strategic vision, excellent planning and a well trained, inexpensive workforce.

Currently, 28 out of the 50 top pharmaceutical/biotechnology companies in the world have facilities in Ireland. Some of these companies are Merck, Wyeth, Genzyme, GlaxoSmithKline, Pfizer, Johnson and Johnson, Schering-Plough and Bristol-Myers Squibb. Seven out of 10 of the world’s top selling blockbuster drugs are now manufactured in Irish production facilities. 

Pharmaceutical companies were the first to set up shop in Ireland. However, biotechnology is growing rapidly and biomanufacturing is starting to over shadow traditional small molecule production. Companies including Wyeth, Centocor, Bristol-Myers Squibb, Organon Biosciences (now part of Schering Plough) and Allergan manufacture biologics and biotechnology products in Ireland. In fact, Ireland is home to the world’s largest biomanufacturing facility, Wyeth’s € 1.3 billion Grange Castle near Dublin.

So why pharma and biotech are companies flocking to Ireland? First, the Irish labor force is well trained, everyone speaks English (albeit with an Irish lilt) and wages are still low. Second, Ireland has the lowest corporate taxes in the entire European Union. Further, there are R&D tax credits and financial support for start ups.  For example, there is financial support to purchase consultancy and innovation vouchers worth €10,000, a substantial amount of money for any startup! Finally, and perhaps most importantly, the Irish government had the foresight to create a public/private enterprise known as the National Development Plan (2000-2006) that invested € 2.5 billion to create an Irish R&D infrastructure.

The Irish strategy–“built it and they will come”– has certainly paid off handsomely for Ireland. Another country that has embraced a similar strategy is Singapore–which through a public/private initiative has been building a vibrant life sciences and biotechnology industry since 1999. Both countries now compete for pharma and biotech business. For example, in late 2007, Merck decided to build a € 200 million vaccine facility at Carlow Town in Southeast Ireland. Novartis, on the other hand, opted for Singapore to build a new $180 million pharmaceutical tabletting facility along side of its API production plant.

Unlike Ireland, the American pharmaceutical and biopharmaceutical industries are in trouble and losing their competitive edge. Perhaps the US can learn a thing or two from the Irish to give its bioscience industry a much needed shot-in-the arm.

Until next year….

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

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Things are not going well these days for Wyeth or the US Food and Drug Administration. In the latest of a series of complaints over FDA's safety review of drugs and industry influence on the agency, a Senate panel found flaws in its scientific objectivity when it reassigned an agency veterinarian over unfounded conflict –of- interest accusations by Wyeth.

The congressional inquiry looked into how the FDA dealt with Wyeth’s accusations against Dr. Victoria Hampshire, an FDA regulator who was helping to review the safety of one of Wyeth’s lucrative veterinary drugs. The case centers on Proheart 6, an injected dog heartworm medication that Wyeth pulled from the market in September 2004 after Hampshire linked the drug to dog deaths. Wyeth later complained about alleged bias by Hampshire. The company claimed that she intend to sell competing drugs through her own Web site. After Wyeth made the allegations, Hampshire was abruptly reassigned to another job within FDA and her case was referred to the U.S. attorney's office for possible criminal prosecution. Federal prosecutors quickly dropped the case, and much to FDA’s chagrin, in 2006, the U.S. Public Health Service named Hampshire veterinarian of the year.

Congressional investigators discovered that FDA referred Hampshire's case to prosecutors on the basis of mistaken allegations about her Web site that could easily have been checked but were not. As it turned out, Hampshire’s did little business at her website and did not sell any products that competed with Proheart 6. In fact, she actually sold Wyeth’s Proheart 6 until the company pulled it from the market. Go figure….

In a letter to HHS Secretary Michael Leavitt and FDA Commissioner Dr. Andrew von Eschenbach, panel Chairman Senator Charles Grassley (R-Iowa) wrote that the panel’s findings suggest “that the scientific process is being compromised internally" at the FDA. Also, he wrote that the case brings into question "the processes that FDA uses in response to industry allegations of wrongdoing by FDA employees."

FYI, a FDA advisory panel narrowly voted to keep Proheart 6 off the market shortly after Hampshire was reassigned in 2004.

Until next time….

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

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Wyeth announced yesterday that it is introducing a generic version of its blockbuster heartburn medication Protonix. The company is embroiled in nasty patent litigation with Israel-based Teva, one of the world’s largest generic drug manufacturers. The lawsuit, filed by Wyeth, claims that TEVA violated a violation of Protonix's patent which is set to expire in 2010. Teva introduced a generic version of the drug in December, which caused Protonix's sales to plummet, but then agreed to temporarily halt selling its rival product, known as pantoprazole, as the two companies engaged in settlement talks.

Protonix, one of Wyeth's top sellers, posted $1.45 billion of sales in the first nine months of 2007. Wyeth yesterday said its generic version would be distributed by Prasco Laboratories, a closely held Cincinnati company. A Teva spokeswoman declined to comment on what Wyeth's generic version means for settlement talks or whether Teva will resume sales of its own generic.

A steep drop in Protonix sales, which would be expected in the face of generic competition, would deliver yet another blow to Wyeth, which has tried and failed to win approval for some of its new medications including Pristiq for menopause symptoms and bazedoxifene for osteoporosis. Wyeth’s unprecedented move of a introducing a generic version of Protonix before patent expiry indicates how reliant the company is on sales of its blockbuster product.

If a court finds that Teva violated the Wyeth patent, Teva may have to pay triple damages awarded to the patent holder.

Until next time…

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

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Well, it had to happen sooner or later.  Wyeth said on Friday it is considering cost cuts that could eliminate 10 percent of its work force over a three-year period.

Wyeth, whose earnings prospects have been hurt by delays last year in approvals of new medicines and the recent launch of a generic form of its blockbuster Protonix ulcer medicine, currently has 50,000 employees worldwide.

A company spokesperson said "It is premature to even begin to discuss which positions will be affected or how (job cuts) will be achieved. We are evaluating our business and trying to find ways to be more efficient, and part of that is to keep costs under control". He noted that details of the initiative will be presented to employees toward the end of March.

Stay tuned for more details!!!!!!

Until next time….

Good Luck and Good Job Hunting (avoid Collegeville, PA)!!!!!!!!!

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Wyeth and its development partner, Tarrytown NY-based Progenics Pharmaceuticals Inc, said on Thursday that U.S. regulators have delayed a review of their experimental drug to treat opioid-induced constipation in order to further review certain safety data.

The U.S. Food and Drug Administration asked for the results of a recently completed study of the drug, methylnaltrexone, on QT prolongation, a disorder of the heart's electrical system. The companies said the study submitted to the FDA examined the effect of intravenous methylnaltrexone, which is being developed for post-operative ileus, a dysfunction of the gastrointestinal tract following surgery.

Both companies hope that FDA will review the application by the end of April, three months later than expected. I suspect that the old adage “If at first you don’t succeed, try, try, and try again” may be the new mantra at Wyeth these days!

Until next time….

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

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I am sure that most of you have heard by now that it takes about $1.0 billion to shepherd a new drug from discovery through commercialization. It is a nice round number but methinks that “something is rotten in pharma land”. The massive pharma layoffs in 2007 were justified because of nearing patent expiry, encroachment by generic manufacturers, over zealous FDA scrutiny and failing stock prices. To that end, how do you explain this little tidbit about Wyeth that my colleague Ed Silverman at Pharmalot reported on late last week? 

As you may know, about three months ago Wyeth’s CEO Bob Essner announced his pending retirement as from the struggling drug maker. It turns out, that Bob will remain chairman through December 31, 2008 and will receive the same $1.73 million in 2008 that he received this year as company CEO.As Ed reported “Bob will also be entitled to a bonus based on his 2008 salary that is “consistent with (his) position,” although his duties are not defined—nor his title. Presumably, Bob is now a consultant.” I along with Ed will look forward to hearing his ideas and what he will be doing for Wyeth over the next 12 months. Maybe he and Bernie Poussot, Wyeth’s new CEO (who will be making a measly $1.5 million this year) can have lunch from time to time to discuss strategy.

Maybe this is why it takes a billion to commercialize a new drug?

Until Next Time

Good Luck and Good Job Hunting (try Wyeth, they apparently have money to burn)

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The AP reported today that Wyeth raised the salary of its new chief executive.

President and Chief Executive Bernard Poussot will receive an annual base salary of $1.5 million, effective Jan. 1, and receive 120,000 restricted stock units that will begin to vest after three years. Poussot was promoted to CEO effective in January.  Remember, this is just Poussot's base salary.

I guess the Board of Directors felt that Bernie needed some front end incentives to keep Wyeth's stock price above $45 per share-not that there is anything wrong with that!  However, I find it troubling that executives are still getting pay raises when thousands of pharma and biotech employees are losing their jobs.  Go figure.....

Until next time...

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

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The news from Wyeth gets more and more interesting every day.  It was reported today that Wyeth intends to follow in the steps of Johnson & Johnson and pull its baby cold medications off the market over industry concerns that some caregivers are misusing the drugs, resulting in accidental overdose.

A Wyeth spokesman reported that the company will stop making Robitussin Infant Cough DM Drops, and will recall two products it discontinued last year, Dimetapp Decongestant Plus Cough Infant Drops and Dimetapp Decongestant Infant Drops. Wyeth also plans to place a warning on its other cold medications advising they should not be used on children under two years of age.

Until next time...

Good Luck and Good Job Hunting (not at Wyeth...)

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On Thursday of last week, Wyeth suffered another blow in a long string of regulatory missteps and intellectual property disputes after a judge ruled that Teva (one of the world’s leading generics companies) and its marketing partner Sun Pharmaceuticals could begin marketing a generic version of Wyeth’s popular anti-heartburn medication Protonix. In the decision, a US district court judge refused to uphold Wyeth’s request to extend an injunction against Teva from marketing its version of Protonix. Teva, which is involved in a patent lawsuit with Wyeth and Altana over Protonix, has not yet said whether it will launch the product.
The patent lawsuit between the companies dates back to 2004. In July 2007, Teva agreed not to launch a generic version of Protonix until either a preliminary injunction was denied or it expired (which happened on Friday). Teva could launch the drug, but it would be considered at-risk because of the pending patent dispute.

The company could face fines if it launches the generic version and ultimately loses the patent lawsuit. The Protonix patent is due to expire in 2010. Protonix sales average around $2.0 billion per year. Introduction of a generic version of the drug could result in a 50% loss in sales for Wyeth.
Wyeth stock price fell sharply after the decision was announced. Wyeth stock has been hammered hard in the past three weeks, which is likely to result in layoffs and job cuts in the near future.

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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