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The recent bad press about Gardasil, Merck’s anti-cervical cancer vaccine, must have been keeping its marketing and advertising executives up at night because the company recently launched a marketing campaign called Charm4Life—a line of jewelry designed to raise awareness about cervical cancer. According to a post at the Pharmalot Blog, women (or concerned men) can pay $32 for any of four “limited edition” bangles designed by Carolyn Rafaelian, a designer with Alex and Ani.  The Charm4Life campaign could also be in response to the likely approval early next year of Cervarix, GlaxoSmithKline’s anti-HPV vaccine.

Merck insists that the campaign is to promote awareness about cervical cancer and that all proceeds from sale of the bangles will go to the Prevent Cancer Foundation. Of course, the real goal of the campaign is to promote Gardasil vaccination by raising their awareness of cervical cancer.  

The $32 price tag for the bangles is way cheaper than the $365 it costs for the Gardasil vaccination series. That said, I hope women don’t buy the bangles and forego Gardasil vaccination.

 

Hat tip to Ed at Pharmalot

 

Until next time…

 

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

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It was only a matter of time after J & J launched its health channel on YouTube two weeks ago, that other pharma companies would begin to post videos on video-sharing sites. As a general rule, nobody in pharma wants to be first but after the first company takes the plunge, nobody wants to be left out or behind. Therefore, it came as no surprise when late last week, GlaxoSmithKline (which has a tendency to be second-to-market with competing products), launched a beta version of it so-called GSKCIC channel on You\Tube.

 According to a post on the Pharmalot blog, so far there are only two videos on the channel. One describes the company ongoing commitment and fight against disease in the developing world (ironically, the video ends prematurely).The second, which is full length, features CEO Andrew Witty telling us about his career at GSK (which began in 1985 as a management trainee) and how GSK is looking for a few good employees who “like a good challenge.” Curiously, the day after the Witty video appeared on YouTube, GSK announced that it was laying off about 90 workers or 10% of its work force at its manufacturing plant in Zebulon, North Carolina. A company spokesperson said that more cuts are expected at the North Carolina facility.

Maybe someone at GSK ought to tell its CEO that the company isn’t hiring at the moment?????????

Hat tip to Ed at Pharmalot!

Until next time….

Good Luck and Good Job Hunting!!!!

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The Avandia debacle is still ravaging the employee ranks at GlaxoSmithKline especially at its Research Triangle Park, North Carolina and in Philadelphia locations. According to a post at Pharmalot, the UK-based drug manufacturer is cutting as many as 350 jobs (2.0% of its workforce) at both locations. This represents an almost 40% reduction in drug discovery and development activities that take place at both sites.

These cuts come after GSK closed a factory and drastically cut its sales force late last year. To make matters worse (particularly for those folks who lost their jobs) GSK purchased an early-stage drug discovery company called Sirtris Pharmaceuticals for about $720 million earlier this year. Clearly, company executives have more faith in external rather than internal drug discovery at GSK.

The saga continues……

Until next time

Good Luck and Good Job Hunting (forget North Carolina)!!!!!

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As many of you may recall, Merck tried unsuccessfully last year to lobby state and federal officials to pass legislation that would require mandatory vaccination of girls aged 9-26 with Gardasil, its anti-HPV, cervical cancer vaccine. Merck came under fire for its efforts (which seemed ethically disingenuous to many). Consequently, the company’s image took a hit and its stock price started to tumble. Although Merck stopped its lobbying campaign (mostly because of bad press and a flagging stock price), Gardasil ads continued to run and went largely unnoticed.

Because GlaxoSmithKline may be close to launching Cervarix^Tm—its cervical cancer vaccine—  the company recently decided that it was time to ramp up its Gardasil advertising efforts. Starting this past Saturday and continuing through June 26, Gardasil ads will be gracing the screens of a theater  near you. The ads will be shown with films like “Sex and the City” (hmmm, clever wouldn’t you say?), “Get Smart” (who doesn’t remember Barbara Feldon), “The Happening” (what woman doesn’t love a scary movie), “You Don’t Mess with the Zohan” (Adam Sandler is hot) and several others. I want to thank Ed Silverman over at Pharmalot for the heads up on this story!  I don't know about you, but I think that showing commercials at the movies, especially those hawking pharmaceutical products, is just plain wrong!!!!!!!!

This isn’t the first appearance of Gardasil ads at the cinema—I recall seeing an ad for Gardasil the last time I went to the movies (I don’t remember the movie but I clearly can recall the ad!). According to a Merck spokeswoman (aren’t pharmaceutical companies clever?), “We purchased advertised space that is relevant for our older female target audiences; specifically for the summer movies that are relevant to those aged 19 through 26.” 

As Ed so eloquently stated in his Pharmalot post: “Of course, plenty of teenagers will be seeing some of these flicks, too. Zohan and Get Smart are rated PG-13. And Sex and The Happening are rated R, but the restrictions only apply for kids under 17– some of whom will, no doubt, see them anyway.  In any event, Gardasil is unlikely to be available as a value pack that includes soda and popcorn. But we (Pharmalot) are curious to know whether the Gardasil beach towel is about to make a comeback.”

 Until next time….

Good Luck and Good Movie Watching!!!!!!!!!!

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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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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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US Food and Drug Administration regulators announced on Friday that it will take three months longer than expected to decide whether Entereg, a treatment for post-operative ileus being co-developed by GlaxoSmithKline, will receive marketing approval. The drug was originally supposed to be reviewed for an up-or-down decision on Feb. 10.

Entereg is being co-developed with Pennsylvania-based Adolor Corporation. Post-operative ileus affects patients after bowel surgery. Symptoms include constipation and other gastrointestinal dysfunction.

An FDA advisory panel recommended approval in January but said Adolor needed to come up with a better plan to manage long term use of the drug. FDA regulators are concerned about safety data showing that long term use of Entereg can have adverse cardiovascular effects.

Adolor has submitted a new risk-management plan to the FDA, which will take the extra three months to review it.  GlaxoSmithKline will split the revenue from any U.S. sales of Entereg with Adolor and is responsible for commercialization of the drug outside the country.

Until next time…

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

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Last December, the US Food and Drug Administration (FDA) asked GlaxoSmithKline for additional information related to its cervical cancer vaccine Cervarix. The company has yet to reply to unspecified queries in the FDA's "complete response letter" that it received last December.

Many analysts believe Cervarix is now unlikely to be launched until 2009 at the earliest. GSK won European regulatory approval last July for the vaccine and had originally anticipated a US launch by the start of this year. However, FDA requested clarification after GSK's submission last April based on interim clinical data that the submitted from its most comprehensive five-year clinical trial for the vaccine. Financial analysts believe that FDA concerns may center on GSK's proprietary AS04 adjuvant that is used  in Cervarix to improve the effectiveness of the vaccine.

The delay has been a serious blow to GSK’s efforts to generate fresh product sales and catch up with Gardasil, the rival HPV vaccine developed by Merck & Co, which is available in the US and Europe.

I wonder whether the delay at FDA is really based on legitimate regulatory and scientific concerns. As you may recall, Merck launched a flat-out, take-no-prisoners lobbying campaign to get State and Federal legislators to mandate that all girls 10-21 years old be vaccinated with Gardasil. While Merck abruptly abandoned its lobbying efforts last fall after it came under fire from various legislative and regulatory sources, I can’t help but wonder whether Merck achieved its intended objectives anyway—to keep Cervarix out of the US market as long as possible so that Merck can capture a majority share of the lucrative American cervical cancer market.

Until next time….

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

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As many of you know, the pharmaceutical industry has been trending downward for the past year or so. Weak pipelines, uncontrolled corporate expansion and soaring drug prices have been offered to explain the recent down turn. However, the real back story to the downturn is the loss of  future revenues that is expected to occur starting in 2010 when many current blockbuster pharmaceutical products, e.g., Lipitor (Pfizer), Plavix (Sanofi Aventis), Avandia (GlaxoSmithKline), Zyprexa (Lilly), and others lose patent protection.

The loss of patent protection of branded blockbuster products is almost always accompanied by the development and subsequent, regulatory approval of lower cost, generic versions of the drugs. The Hatch Waxman Act permits generic manufacturers to begin to develop generic versions of branded products five years prior to patent expiry. This allows generic manufacturers to develop and gain regulatory approval of their products well in advance of a patent expiry date. Further, generic manufacturers usually launch their products (and flood the market) with generic versions of a branded product on the same day that its patent lapses. To induce and hasten generic development, Hatch Waxman grants market exclusivity for 180-days (6 month) to the first company that gains US regulatory approval for a generic version of a branded product that has lost patent protection.

Revenue generation and a company’s market share of branded drug products generally fall precipitously following introduction of less costly, generic versions of the drugs. From a financial standpoint, this is not surprising—why would anybody chose to pay more for a branded product when there is a cheaper and therapeutically efficacious generic alternative available?  In the past, most pharmaceutical companies chose to neglect (and ultimately abandon) blockbuster products after generic versions were introduced.  Many companies chose this strategy because, in the past, there was always another blockbuster in the pipeline that would replace the lost revenues caused by generic competition.

Unfortunately, as we all know, the days of the billon-dollar-a year blockbuster drug are long gone! This realization has caused many pharmaceutical companies to rethink their business strategies when a blockbuster drugs lose patent expiry. Many pharmaceutical companies are experimenting with a relatively new kind of product called an authorized generic–a copycat version of a company’s branded drug that is sold through a licensing agreement between the innovator company and a generic-drug manufacturer. This type of arrangement allows the innovator company to hold on to a larger share of a revenue stream from the drug once it loses patent protection and it falls prey to generic manufacturers.

Authorized generics have always made sense to me–who knows how to manufacture, market and distribute a drug better than the company that originally created it? Further, why would a company choose to give up on a revenue stream simply because a product can no longer generate billions each year due to generic encroachment– wouldn’t hundreds or even tens of millions suffice? Much to my surprise, late last week, Merck & Co announced that it had inked a deal for an authorized generic form of its blockbuster osteoporosis drug  Fosamax after the US patent expires on February 6. Merck did not disclose the terms of the deal or the identity of it generic manufacturing partner.

Industry analysts have suggested that cheaper generics will not only batter sales of Merck’s Fosomax but could also hurt rival Actonel (Proctor & Gamble Co/Sanofi-Aventis) and Boniva (Roche/GalxoSmithKline). Generic manufacturers.  Barr Laboratories and TEVA are expected to launch their own generic versions on February 6 and share the 180-day market exclusivity for their respective products.

Merck, once a champion of the old pharma blockbuster model, is slowing emerging as an industry innovator. The company’s recent decision to authorize a generic version of one of its former blockbuster drugs may be a harbinger of things to come in the pharmaceutical industry. That said, I don’t understand why big biotechnology companies like Amgen, Biogen/IDEC and Genentech are unwilling to consider the authorized generic model to stave off generic competition for blockbuster biotechnology products like EPO, Avonex and Rituxan. Whether these companies like it or not, I believe that biogenerics aka follow-on biologics will be a reality in the US in the next five years. Maybe Amgen can bolster is rapidly falling stock price by inking an authorized generic deal for EPO—rather than spending hundreds of millions on patent litigation—“whadda ya think?”

Until next time…

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

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Geneva-based Covalence published its third annual ethical reputation ranking, giving the best ranked companies as well as those companies which have made the most progress in 2007.

Best EthicalQuote Score and Best EthicalQuote Progress are given by confronting positive and negative news. Best Reported Performance is calculated by quantifying positive news only – it shows how companies report on their ethical performance without considering criticisms and demands.

Best EthicalQuote Score

1. GlaxoSmithKline
2. Johnson & Johnson
3. Bristol Myers Squibb
4. Abbott
5. Novartis
6. Roche
7. Boehringer Ingelheim
8. Astra Zeneca
9. Pfizer
10. Sanofi Aventis

Best EthicalQuote Progress

1. GlaxoSmithKline
2. Abbott
3. Johnson & Johnson
4. Sanofi Aventis
5. Boehringer Ingelheim
6. Schering Plough
7. Takeda
8. Astra Zeneca
9. Bristol Myers Squibb
10. Amgen

Best Reported Performance

1. GlaxoSmithKline
2. Abbott
3. Novartis
4. Wyeth
5. Merck & Co Inc
6. Pfizer
7. Johnson & Johnson
8. Eli Lilly
9. Sanofi Aventis
10. Astra Zeneca

Finally, some good news for GSK in 2007!!!!

Until next time...

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

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The New York times reported today that Britain’s Serious Fraud Office has demanded documents from GlaxoSmithKline, Astra Zeneca and a British affiliate of Eli Lilly & Company in connections with allegations that the companies paid bribes to secure lucrative drug contracts in Iraq while Saddam Hussein was in power. The 3 companies are accused of violating the United Nations’ oil-for-food program that was instituted in post war Iraq in the 1990s.

A report from the fraud office in 2005 accused some 2,200 companies from 40 countries of colluding with the Hussein regime to cheat the UN program out of about $1.8 billion. As I have stated time and time again, drug companies are no different than other companies–profits and stock prices always come before ethics, morality and sometimes the law!

Until next time….

Good Luck and Good Job Hunting!!!!

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GlaxoSmithKline announced today that the U.S. Food and Drug Administration wants more information on its cervical-cancer vaccine called Cervarix before clearing it for sale, giving Merck & Co. more time before a rival comes to market. As you may know, Merck was first to market with its highly touted (and somewhat controversial) cervical cancer vaccine called Gardasil. Both vaccines protect against infections with certain human papilloma virus (HPV) strains that cause over 99.9% of all cases of cervical cancer. Gardasil targets four strains of HPV - including two causing cancer and two causing genital warts, while Cervarix targets only the two cancer strains.

According to Ed Silverman at Pharmalot, “the FDA has issued a so-called ‘complete response letter’ for its Cervarix vaccine. Although it’s not clear, though, whether the agency wants additional trials, leaving open the possibility that the unexpected delay in approval can last anywhere from just six months to up to two years.”

As you may recall, Merck was actively lobbying state and federal legislators earlier this year to make Gardasil vaccination mandatory for girls aged 12 and older. I find it interesting that the agency is questioning Cervarix’s approvability given Merck previous and extremely vigorous lobbying campaign for mandatory vaccination with Gardasil.  “executives shouldn’t blame their problems on FDA being slow to green light new medicines”. Thank you for the insight Mr. Clark!
GSK has high hopes for Cervarix expecting it to be a billion-dollar-a-year product. FDA’s decision to delay approval of Cervarix is more bad news for GSK which has taken big revenue hit because of safety concerns with its anti-diabetes drug Avandia. Look for continued right-sizing at GSK.

Until next time….

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

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The New York Times reported today that an independent study that analyzed thousands of older people with diabetes found that those treated with the widely used drug Avandia had significantly elevated risks of heart attack and death.

According to the Times article, the finding, published on Tuesday, in this month’s Journal of the American Medical Association (JAMA), could rekindle the debate about whether Avandia, a controversial treatment for Type 2 Diabetes, should remain on the market. Earlier studies drew similar links between Avandia and cardiac risks.

The new study concludes that Avandia users had a 60 percent increased risk of heart failure, a 40 percent increased risk of heart attacks and a 30 percent increased risk of death compared with patients taking other oral diabetes medicines.

Sales of the drug, formerly a $3.4 billion product globally, have declined sharply since June 2007 when an article appears in the  questioning the drug's safety.

Not good news for GSK. The big question now is whether the company ought to cut its losses and take Avandia off the market or continue to squeeze as much money out of the product until lawsuits begin to accumulate.

Until next time…

Good Luck and Good Job Hunting (not at GSK)!!!!!!!!!!!

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A sharp drop in sales of its blockbuster diabetes medication Avandia has forced GlaxoSmithKline (GSK) to embark on a major cost cutting campaign that includes job cuts. It is not clear where the cuts will take place or how many jobs will be lost. The company said it would close some of its manufacturing plants, including a plant in Puerto Rico which employs around 900 workers and has been a target of regulatory scrutiny because of ongoing quality control issues.

Although this is the first official public announcement of layoffs at GSK, my inside sources tell me that several hundred employees have already lost their jobs at GSK’s Collegeville, PA facility.

GSK’s announcement coupled with a sharp drop in Amgen’s third quarter profits and Lilly’s problems with clinical development of prasugrel (its highly anticipated anti-clotting drug) indicate that the road will be rather bumpy for the biopharmaceutical sector in the near future.

Until next time…

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

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