Mea Culpa: Allergan is Not Closing a Botox Production Facility

I inadvertantly misreported the story about Allergan closing an Irish manufacturing facility. I want to thank a reader for correcting the error.  The company is closing the production facility in Arkow which manufactures silicon implants.  Another facility in Westport produces Botox.  I guess getting rid of wrinkles is still de riguer whereas larger breasts may not in vogue anymore.

I apologize for myerror...stuff happens!  And thanks to those intrepid individuals who actually take the time to read what I post!

Until next time....

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

Allergan to Close a Botox Manufacturing Plant in Ireland

Allergan Inc., the maker of Botox, will close a plant in Ireland, eliminating 300 jobs, and transfer production to a factory in Costa Rica.

Ireland has lost about 10 percent of its manufacturing jobs over the last six years, as labor costs climb. As many of you may know, many US pharmaceutical and biotechnology companies set up production facilities in Ireland over the past 10 years or so because of its well trained workforce and lower labor costs.  However, because the Irish economy has grown so quickly and its middle has prospered, labor costs have been rising and manufacturers are now looking elsewhere to control costs. Unfortunately, this is likely to be harbinger of things to come for markets that were once sources of cheap, skilled labor.

Until next time….

Good Luck and Good Job Hunting Lasses and Laddies!!!!!!!!

Authorized Generics Have Arrived: Wyeth Launch's a Generic Version of its Protonix Brand

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)!!!!!!!!!!!!

Carl Ichan Declares War on Biogen

Despite putting itself up for sale and finding no buyers, Carl Icahn still believes that Biogen is an attractive buyout opportunity for some unsuspecting pharma company. In fact, it was Carl who forced Biogen to put itself up for sale last fall (to avert a nasty proxy fight that he threatened). Carl, who owns 4.2 % of the company, believed that Biogen was underperforming and its stock price was too low.

To make his ongoing dream a reality, Mr. Icahn moved today to appoint three members (loyal to him) to the Biogen board. In an SEC filing, Mr. Ichan said that at Biogen's upcoming shareholder meeting he will nominate three people to Biogen's board (which elects four directors each year), and seek to cap the board's size at 12. If successful, Mr. Icahn would then be “within striking distance” to control a majority of Biogen's board by next year.

The three people that Icahn nominated were Alexander Denner, managing director of the Icahn investment vehicle Icahn Partners; Richard Mulligan, professor of genetics at Harvard Medical School and Dr. Anne Young, head of the neurology at Massachusetts General Hospital. Interestingly, Dr. Mulligan and Mr. Denner also serve on the board of ImClone Systems, which elected Icahn chairman last year, after a bitter battle during which Icahn accused the ImClone management of improperly developing its cancer drug Erbitux.

Carl has taken a fancy to biotech in recent years and now considers himself to be somewhat of maven.  Although there a molecular biology building at Princeton University which bears his name (he is an alumnus), he is still a corporate raider at heart. After moving into MedImmune stock in early 2007, Icahn threatened a proxy contest at the annual meeting if it did not find a buyer. Several days later, AstraZeneca said it would buy MedImmune for a whopping $15.6 billion. Carl usually gets what he sets out to do.

It appears that Biogen has not heard the last from Mr. Icahn. I suspect that things will continue to get ugly in Cambridge. Stayed tuned for updates!

Until next time…

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

More Pfizer Employees to Lose Their Jobs

 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)!!!!!!!!!!

Unraveling the Cholesterol Conundrum

Unraveling the Cholesterol Conundrum

By now, I am sure that everyone is sick of hearing about Zetia, Vytorin, cholesterol levels and heart disease. Whether you like it or not, results from the now infamous Enhance study have certainly caused many scientists and physicians to rethink the relationship between cholesterol levels and heart disease and stroke. Conventional wisdom (and current medical dogma) holds that low LDL cholesterol levels reduce the risk and incidence of heart disease and stroke. This belief is now so widespread and entrenched in that the medical community that FDA now approves drugs to prevent heart disease, as it did with Zetia and Vytorin, solely on the evidence that they lower LDL cholesterol levels. Unfortunately, Enhance study results indicate that lowering LDL cholesterol levels alone are not sufficient to reduce the incidence of heart disease or stroke. 

Zetia, one of the active ingredients of Vytorin, lowers blood LDL cholesterol levels by reducing absorption of cholesterol in the gut (from foods that we eat). In contrast, the other ingredient in Vytorin, Zocor, is a statin that acts to lower LDL cholesterol by interfering with its production in the body. The results of the Enhance study, which showed that Vytorin doesn’t reduce the risk of heart disease or stroke any better than Zocor itself, suggest that the only way to prevent heart disease and stroke (by lowering LDL cholesterol) is through statin use. This assertion is supported by results from clinical trials involving Lipitor and Zocor (both statins), which showed that lowering LDL cholesterol also resulted in a lower incidence of heart disease and stroke. This suggests that statins may act to reduce heart disease and stroke by mechanisms other than their LDL cholesterol-lowering properties. Indeed, statins have also been found to reduce inflammation, keep artery walls flexible and healthy and help to maintain LDL and HDL cholesterol balance in the blood.

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FDA to Expand Scope of Foreign Inspections-Gee, What a Novel Idea!

The US Food and Drug Administration announced late last week that it intends to post inspectors in embassies and consulates throughout the developing world to improve the quality of the food and medicines that flow into the US. FDA Commissioner Andrew C. von Eschenbach (Bush’s latest appointee to head the agency), said that he wants to have “boots-on-the-ground in developing nations like India and China and regions like Central and South America and the Middle East.” At present, less than 1% of the food imported into the US is inspected each year

As many of you know, FDA inspectors are required to visit both domestic and foreign manufacturing facilities that produce food, cosmetics and medicines that are sold in the US. By law, these inspections must take place every 3 years. Unfortunately, due to budget shortfalls and inspector shortages, routine inspections at domestic facilities are now taking place every 4 to 5 years– it is unclear how frequently inspections occur at foreign manufacturing facilities.  Based on von Eschenbach’s call for more foreign-based inspectors, the answer is likely “not frequently enough.”

The obvious solution to this problem is to increase the agency’s budget to hire and train new inspectors. However, despite repeated attempts by lawmakers, the Bush administration has steadfastly refused to endorse or consider budget increases for the agency. Instead, White House officials have urged the agency to uses any means possible to “bolster the aggressiveness and effectiveness of foreign health regulators” to prevent unsafe or tainted products from reaching the US market. I do not want to sound overly cynical but good will can go only so far with financial inducements or incentives.

Despite the obvious need for more inspectors, von Eschenbach admitted that his plan to post inspectors in foreign countries is “only in its infancy”. Also, he hasn’t decided whether he will ask Congress for additional funding for the agency or find money in the current budget for the foreign inspectors. I suspect that “finding money” in the current budget would translate into curbing other regulatory activities at FDA –something that would not bode well for the already-embattled agency. The inability of von Eschenbach to secure funding to train and deploy new inspectors is another reason why I believe that the FDA Commissioner ought not to be a political appointee!

Until next time…

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

Job Cuts Announced at Wyeth

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)!!!!!!!!!

Some Good News for Amgen

Amgen announced yesterday that its osteoporosis drug, denosumab, was safe and outperformed Merck’s Fosamax to improve bone density in a small Phase III clinical trial that included almost 1,200 patients. Unlike Fosamax which is taken orally once a month, denosumab (a fully humanized monoclonal antibody) only needs to be injected twice a year. As mentioned in a previous post, Fosamax will be losing patent protection and Merck recently announced that it will sell an authorized generic version of the drug. Fosamax and its generic equivalent represent the stiffest competition for denosumab if it receives regulatory approval.

Despite being the largest biotechnology company in the world, Amgen has struggled for the past year due to declining sales from its EPO franchise. Amgen’s pipeline is thin and company executives have bet the future on denosumab becoming a top seller. That said, the key measure for any osteoporosis drug is whether it can reduce or prevent bone fractures. Results from a pivotal Phase III clinical trial with over 8,000 patients comparing denosumab to placebo in fracture prevention are expected later in 2008.

I bet  a lot of employees in a Thousand Oaks have their fingers crossed!

Until next time….

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

Time for Some Belt Tightening: Eli Lilly Trims Retirement Healthcare Benefits

The Indianapolis Star reportsed that more than 20,000 Lilly employees will have to pay a larger share of their health-care premiums when they retire, and some might wind up working longer than expected to earn their full pensions, The changes are designed to keep benefits plans sustainable for years to come, according to a Lilly spokesman. Also according to Lilly, the drug maker, which has been shedding workers through attrition, is not using the changes to further reduce head count or to increase retirements-YEAH RIGHT!

I find it ironic that Lilly is spending millions of dollars to lobby against legislation allowing importation of lower-priced prescription drugs – and at the same time– is requiring its former employees (who EARNED their retirement benefits) to pay more for their medical coverage because of skyrocketing prescriptions drug and healthcare costs! 

Go figure!!!!!!!!!!

Until next time...

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

Never Bite the Hand That Feeds You!

The New York Time reported today that the American Heart Association (AHA) publicly advised patients who are taking Vytorin “not to abruptly stop taking the medication without consulting their physicians.” On the surface, this would appear to be sage advice from physicians who have their patient’s' health and best interest at heart (so to speak). However, it  could be interpreted differently when you learn that the AHA receives nearly $2.0 million form Merck Schering/Plough Pharmaceuticals, the joint venture that markets and sells Vytorin! Call me crazy-but no matter which way you slice, dice or spin it-there is an inherent conflict of interest here. How can you expect a professional organization (that subsists largely on member dues and advertising revenue) to be objective about a product that is manufactured by a company that underwrites part of its operating budget? As one of the democratic candidates asserted the other night in the South Carolina debate –whether you accept campaign contributions yourself or the contributions are accepted on your behalf, you know in the back of your mind that you owe that individual/corporation something in return. As the old adage goes “Never bite the hand that feeds you”.

Don’t get me wrong, I don’t care where or how the AHA gets its money. That said, if AHA had disclosed that it receives money from Merck /Schering Plough Pharmaceuticals, the public recommendation about Vytorin use might have been viewed in a different light. The failure of AHA to disclose its financial relationship with Merck/Schering Plough Pharmaceuticals has, in my opinion, hurt its image and weakened its credibility with the American public. 

Until next time….

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

GSK to Close US Penicillin-Manufacturing Plant

Hat tip to Ed Silverman over at Pharmalot for alerting me to story. GlaxoSmithKline announced Tuesday that it will begin laying off workers at its pharmaceutical manufacturing plant in Bristol, TN.

The company plans to lay off all 236 people currently employed at its manufacturing plant, then cease operations. Layoffs are scheduled to begin April 7 and be completed by Oct. 31, 2009. GSK originally announced plans to close its 400,000-square-foot plant in 2006, citing declining sales of its leading penicillin drug, Augmentin. The Bristol facility is the only U.S. manufacturing facility still producing –all other Augmentin production occurs overseas.

It will take 18 months to close the facility because of existing contracts and complications related to cleaning the building. GSK plans to sell the facility once it closes.

In addition to the jobs that will be lost, the company pays almost $900,000 per year in city and county property taxes and is one of the city’s largest users of electricity, water and sewer services. "One of the big problems is that building has produced penicillin-based medicine and that limits what can go back into it" Sparks, said Bristol Deputy City Manager Sparks. "It’s a big, big hit on the community and if we can do something to replace them we will."

In addition to the antibiotic operation, GSK plans to close its print shop and an off-site plastics processing facility that makes bottles for the Bristol plant.

Until next time….

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

Celgene Promises Bonuses to Pharmion Employees Who Remain With the Company

When was the last time that you heard that a company which was acquiring another one was willing to pay employees bonuses to induce them to remain at the company until the acquisition was complete? Usually, acquisitions are followed by corporate right-sizing and job layoffs! Sometimes good things happen to good people!

As many of you may know, Summit, NJ -based Celgene (the company that turned thalidomide, a product with a long history of serious safety issues, into a safe and efficacious multi-million dollar treatment for leprosy and certain types of cancer) announced plans last November to acquire Denver, CO-based Pharmion for $2.9 billion.

To make the transition smoother, Celgene announced today that it would offer bonuses to Pharmion employees who remain with the company until the acquisition is complete. According to a Celgene representative, Pharmion workers hired by the Nov. 18 announcement of the $2.9 billion sale will qualify to receive pay 25 percent above their normal pay grade for staying on until June 1; staying between then and the end of the year triggers 50 percent pay bonuses. The bonuses apply to all non-field sales employees. Executive staff with contracts that spell out departure payments will receive different payments.

Celgene plans to make Pharmion a wholly-owned subsidiary and, in doing so, pickup the right to distribute the treatments for myelodysplastic syndromes and other drugs that Pharmion has been seeking regulatory approval in the United States and Europe.

Pharmion employed about 550 people, about 50 of whom worked at its Boulder headquarters. The rest were spread among offices in Overland Park, Kan., San Francisco, London and elsewhere.

Until next time…

Good Luck and Good Job Hunting (try Boulder after June 1st)!!!!!!!!!

Eli Lilly & Co Vows to Fight US Legislation That Allows Importation of Lower-Priced Prescription Drugs

As the cost of prescription drugs continues to spiral upward, the affordability and accessibility to prescription drugs and healthcare will likely be fiercely debated and may influence the outcome of the presidential election next November. Despite growing public concern over the cost of prescription drugs in the US, Eli Lilly has vowed to fight federal legislation that will allow Americans to import lower-priced prescription drugs from Canada, Japan, Australia and many European nations. Lilly spokespeople and their lobbyists in Washington DC argue that the policy would put consumers at huge risk of consuming dangerous and unsafe counterfeit drugs. Big pharma has been using the drug safety argument for the past decade or so to stifle drug importation legislation. That said, blocking prescription drug importation legislation has very little to do with drug safety and everything to do with profit margins and corporate stock prices.

The stakes of prescription drug importation are high for drug makers. In contrast with the US, most other countries keep drug prices low through government distribution programs and strict price controls. Because the US government does not control prescription drug prices, American typically pay two-thirds more than Canadians, 80% more than Germans and 100 per cent more than French residents for identical prescription drugs. Lilly and other big pharma companies contend that price controls for prescription drugs stifle innovation and competition (tell that to the European and Japanese drug companies). Currently, according to government and industry surveillance data only a tiny fraction of counterfeit drugs (about 5 per cent) actually enter the US market. But Lilly and other pharmaceutical companies argue that there could be enormous increases in the number of counterfeit drugs that enter the US annually if Congress relaxes the federal ban on imported prescription drugs.

Pharma’s counterfeit drug argument is a convenient scare tactic that it has been using to lobby against relaxing current drug importation legislation. What the drug makers don’t tell you is that they routinely import and sell drugs in America that are manufactured in foreign production facilities. Further, many of drugs that are sold in Canada, Europe, Japan and Australia are manufactured in the same production facilities that supply drugs that are sold in the US. This begs the question —if drugs are manufactured in the same foreign production facilities and one lot is sold in the US and the other in Canada, would American consumers really be at a greater risk if they bought a Company’s drug in Canada or the US? The answer to the question is a resounding NO–unless you believe that the Canadian Regulatory Agency is less competent at monitoring and approving drugs than the US FDA The real story is this–.counterfeiters stand to make much more money selling bogus prescription drugs in the US than in other countries because there are no price controls in the US (which means much larger profit margins for the counterfeiters–duh!)

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Merck and Schering Plough Fight Back to Calm the Cholesterol Controversy

Merck and Schering Plough have taken out two-page ads in several major newspapers defending their cholesterol drugs Zetia and Vytorin whose efficacy has been seriously questioned following release of data from a clinical study called ENHANCE late last week. The new ad campaign takes direct aim at the fallout from ENHANCE which showed that neither Zetia nor Vytorin (Zetia plus Zocor) is more effective in preventing heart attack or stroke than a cheaper generic version of Zocor alone.

The ad offsets the most important line in boldface: "All of us at Merck and Schering-Plough proudly stand behind the established efficacy and safety profiles of ZETIA and VYTORIN." And then it's "signed" by Robert J. Spiegel MD, Chief Medical Officer of Schering and Merck’s VP of External Medical and Scientific Affairs, Richard Murray MD. However, this advertising blitz may be too little, too late. Consumer and physician confidence in Merck and Schering Plough have fallen precipitously after the ENHANCE data were released last week.

According to various sources, the companies reportedly spent more than $100 million on a highly visible, slick marketing campaign to promote Vytorin and Zetia last year. Who doesn’t recognize the ubiquitous commercials with the folksy violin music and the "colorful" relatives dressed to look like food to accentuate the point that cholesterol levels are related to family history (genetics) and the foods that one consume. They have taken a new tact with today’s ads which showcase a matter-of-fact advertising approach. We'll see if it the new, less flamboyant advertising campaign can staunch the hemorrhaging that it taking place today at both companies.

Until next time…

Good Luck and Good Job Hunting!!!!!

Something is Definitely Fishy: Congress Announces Plans to Expand Vytorin Probe

I want to thank for his intrepid reporting on the Vytorin scandal and keeping BioJobBlog abreast of all late-breaking news and rumors that are flying about. 

In today’s post Ed reports that  “…..the House Energy and Commerce Committee wants to know more about the so-called independent panel formed to review the Vytorin trial data, the study’s Data Safety Monitoring Board, stock sales by Schering-Plough execs and the amount of money spent on Vytorin by the Centers for Medicare and Medicaid Services (CMS), given the Enhance trial results showed the drug wasn’t more effective than cheap generic versions of Zocor, which is part of the Vytorin combo therapy.

The congressmen leading the probe - John Dingell and Bart Stupak, both Democrats from Michigan - sent separate letters today seeking all sorts of info from CMS and Schering-Plough. Already, they’re looking at whether Merck and Schering-Plough concealed or manipulated clinical trial data, given that the release of the Vytorin data was delayed nearly two years and the primary endpoint was briefly changed without the consent of the lead investigator. The probe is also focusing on the heavy advertising for Vytorin.

The Vytorin scandal coupled with the Vioxx debacle has done little to instill any consumer confidence in the pharmaceutical industry or the US Food and Drug Administration. Industry’s growing involvement in the drug regulatory approval process coupled with the Bush Administration’s intentional destabilization of FDA has resulted in the recent approval of drugs with dubious therapeutic efficacy and questionable safety profiles. 

Pharma has made it abundantly clear that profits are more important than patients’ health or safety. It is time for the Congress and the American people to stuff the corporate genie and its unbridled avarice back in the bottle!

Until next time….

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

Vytorin Lawsuits: Let the Games Begin!!!!!

It was only a matter of time. On Thursday, a lawsuit seeking class-action certification was filed against Merck and Schering-Plough in federal court in Seattle, alleging the companies violated state consumer protection laws arising from the sale and marketing of Zetia and Vytorin. The suit claims the companies have known since 2006 that the cholesterol-lowering drugs, Zetia and Vytorin (which is a combination of Zetia and Zocor), were no more effective than a generic version of Zocor in blocking arterial plaques that can cause heart attack and stroke, as the drug makers led consumers to believe.

The lawyers who filed the suit charged that Schering-Plough promoted Zetia heavily– advertising that by adding it to a statin treatment like Zocor– patients could more effectively lower LDL cholesterol which they claimed would, in turn, reduce plaque in patients’ arteries. But they maintain that the companies had information that refuted this claim. This assertion was supported by the release, earlier in the week, of results of the ENHANCE clinical study which showed that while Vytorin reduced LDL cholesterol levels it did not significantly reduce arterial plaque or lower the risk of heart attack or stroke any more than simvastatin, a lower-priced, generic form of Zocor.

The suit also calls into question the timing of the release of the ENHANCE study results. According to the complaint, Merck and Schering-Plough knew the results of the trial but delayed sharing the findings with patients for nearly two years, but failed to change their marketing approach. , the US Congress is investigating the same allegation. The lawsuit seeks the return of money to purchasers of Vytorin and Zetia, but won’t seek relief for personal injuries alleged to have resulted from taking Vytorin or Zetia.

Wouldn’t America be a boring place to live without lawyers?

Until next time…

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

BMS Closes Another Puerto Rican Manufacturing Plant

Bristol-Myers Squibb announced today that it will close a 37-year-old pill manufacturing plant in the city of Barceloneta in Puerto Rico. The company plans to shut down operations at the facility over the next 12 months, eliminating about 225 jobs. The reasons for the closing were slowing demand for drugs manufactured at the facility, including two AIDS treatments and an antibiotic and a general need to cut corporate manufacturing costs. As you may recall, Bristol-Myers recently announced a restructuring to eliminate 4,300 jobs and save $1.5 billion.

This is the second time in the past few months that Bristol-Myers has announced plans to close a Puerto Rican production plant.  Last October, BMS announced that it intended to close a manufacturing facility in Mayaguez that made Pravachol (cholesterol-lowering), the Abilify (schizophrenia) and Glucophage (diabetes) that cost 400 employees their jobs. Not to worry–the company said it will continue to operate two other plants in the Puerto Rican cities of Humacao and Manati. About 3,000 high-paying pharmaceutical manufacturing jobs have been lost in Puerto Rico over the past year–given this growing trend, I think that the Puerto Rican government ought to begin to worry about its economic future.

Until next time….

Good Luck and Good Job Hunting (try China, India and Singapore)

When it Rains it Pours: The State of New Jersey Requests Amgen Documents for Off-Label Marketing of Enbrel

Still reeling from lawsuits filed last week by ex-sales reps’ alleging improper marking of Enbrel to treat patients with psoriasis, Amgen was subpoenaed on Monday by New Jersey's attorney general regarding allegations that the company promoted Enbrel for unapproved uses.

In the subpoena served Monday, Attorney General Anne Milgram is seeking "a comprehensive array of documents and information" concerning the marketing and sale of Enbrel from July 2002 to the present.

The subpoena calls for Amgen to deliver the required materials by Feb. 4.

Although doctors are free to prescribe medicines as they see fit, drug companies are only allowed to promote their products for uses that have been approved by the U.S. Food and Drug Administration and appear on product labels.

Until next time…

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

A New DNA-Based Diagnostic Test to Predict Prostate Cancer

Sometimes things just seem to occur randomly or by cosmic convergence. Yesterday, my good friend Pete learned that he had prostate cancer. His prostate specific antigen (PSA) levels were slightly elevated over the past few years (they were in a gray zone that made a definitive diagnosis difficult without doing a biopsy). After being urged by his wife and urologist, he had the biopsy performed and, unfortunately, a diagnosis of prostate cancer was made. Hopefully, his cancer is localized to the prostate and will be easily treated via conventional therapies. As many of you may know, prostate cancer is easily treat and the cure rates high if it is detected early.

The use of PSA levels to diagnosis prostate cancer is notoriously unreliable and inaccurate.Today, a group of Swedish scientists announced that they developed a DNA-based test that showed that men carrying a combination of known risk genes run a four to five time higher risk of developing prostate cancer. They envision that this test could be used in tandem with PSA monitoring to more accurately diagnose prostate cancer. I hope that they are right!

Unfortunately, the new test wasn't developed in time to help Pete; but perhaps it can be used in the future to more accurately assess the risk and diagnose prostate cancer quickly so that treatment begins as soon as possible!

Until next time…

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

Inhalable Insulin: Not Worth the Effort?

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!!!!!!!!!!

Methinks "Something is Rotten in the State of Switzerland (?): Novartis' Profits Drop by 45% and Job Cuts Continue

Swiss drug maker Novartis on Thursday reported a 45% drop in its fourth-quarter profit, after taking a $444 million charge to revamp its pharmaceutical business affected by generic competition for several of its blockbuster products and a failure to roll out new drugs in a timely fashion.

A Novartis spokesperson said the $444 million charge will help pay for a program that will slash 2,500 of its nearly 100,000 jobs, as the company attempts to save $1.6 billion by 2010.

The company’s pharmaceutical business was hurt by a 21% drop in sales from the United States due to generic competition for its blood-pressure medication Lotrel, the Lamisil nail-fungus treatment, epilepsy drug Trileptal and herpes drug Famvir. The suspension of a bowel-syndrome drug Zelnorm over heart risks also weighed on U.S. sales. Novartis also has struggled to get its Galvus diabetes drug approved in the US. FDA declined to approve Galvus without the company conducting another clinical trial– and Novartis is still in talks with the FDA over what that trial should be.  Novartis also has failed to win FDA approval for a painkiller called Prexige.

Until next time….

Good Luck and Good Job Hunting (try Roche or Sanofi Aventis)!!!!!!!!!!

Lowering Cholesterol May Not Benefit Fred Hassan or Schering Plough

Fred Hassan joined Schering Plough as its CEO five years ago. At that time, Mr. Hassan inherited a company that was being investigated by FDA for regulatory compliance violations and the SEC was investigating it former CEO for investing and accounting irregularities. Since his arrival at the company, Mr. Hassan increased sales of key products, filled an empty product pipeline and returned profitability to a company that posted losses in 2003 and 2004.  

Much of his success can be attributed to Zetia and Vytorin, cholesterol-lowering drugs Schering Plough sells jointly with Merck & Co. Zetia lowers blood cholesterol levels by preventing absorption of dietary cholesterol from the gut. Vytorin is a combination product that contains Zetia and Merck’s statin drug called Zocor. Statins help to reduce blood cholesterol by inhibiting its production in the liver. Sales of both drugs have doubled to $5 billion a year since 2005. But that rich revenue stream is at risk following this week's disclosure that results from a large scale clinical trial called ENHANCE (which was initiated in 2002) showed that Vytorin did not reduce the incidence of atherosclerosis or lower the risk of heart attacks or strokes.

Schering and Merck said Monday that results of the now-controversial ENHANCE study showed that Vytorin failed to slow progression of heart disease more effectively than simvastatin generic form of Zocor that is sold at a far lower price. After learning about the results of the study, Dr. Steven E. Nissen, chairman of cardiovascular medicine at the Cleveland Clinic  quipped "Here we are, six years after this drug was marketed and promoted with a massive marketing campaign and has become a $5 billion drug" without evidence that it works as well as a statin. Now, "the first trial we have, is reported much too late and doesn't show really any evidence of benefit."

As reported in the Wall Street Journal “The impact of the finding was amplified by a long delay in releasing the results, and the revelation in November that the researchers considered altering the study's primary goals -- widely considered a violation of scientific protocol. The developments exposed the companies to suspicions -- which they have denied -- that they had postponed announcing the results because they were unfavorable. Also, the results of the Enhance trial were announced at a press conference rather than published in a peer reviewed scientific journal.”

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Authorized Generics: A New Business Model for Pharmaceutical Companies?

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.

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Tysabri: A Drug Snatched from the "Jaws of Defeat"

You gotta give Biogen/IDEC and Elan credit for winning regulatory approval for a product that was previously pulled from the market because of serious and potentially life-threatening side effects. On Monday, the US Food and Drug Administration granted regulatory approval for Tysabri as a treatment for patients with severe Crohn’s disease who do not respond to more conventional biotechnology treatments like Humira (Abbott Laboratories) and Remicade (Johnson & Johnson). About 500,000 patients in the US suffer from Crohn’s disease (an autoimmune disease) and usually causes diarrhea, fever and severe intestinal inflammation and bleeding. Currently, there is no known cure for the disease.

As many of you may recall, Tysabri, a treatment for multiple sclerosis, was temporary pulled from the market in 2005 after three patients treated with the drug developed a rare and sometimes fatal nervous disorder called multifocal leukoencephalopathy (MFL). FDA allowed the drug back on to the market in 2006 but only under a restricted distribution program. Tysabri is used by more than 12,000 Americans with multiple sclerosis . Since its reintroduction, there have been no new reports of MFL or other serious side effects. Because of its past safety record, patients with Crohn’s disease who use the drug must also enroll in a distribution program similar to the one required for MS patients treated with Tysabri.

The approval of Tysabri for a new therapeutic indication may make Biogen/IDEC a more attractive  takeover candidate. As many of you may know, Biogen/IDEC put itself up for sale about 3 months ago and was unable to find a buyer.

Until next time….

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

Update on the PEGylation Wars: Schering Plough vs Roche

There are currently two injectable products on the market that are used to treat chronic Hepatitis C infections. Both products, PEG-INTRON (Schering Plough) and Pegasys (Roche) are PEGylated versions of the cytokine interferon-alpha that are used in combination with ribavarin (an orally-delivered small molecule drug) to treat patients infected with Hepatitis C virus.  

PEG-INTRON (peginterferon alpha-2b) was co-developed by Schering Plough and Enzon in the early 1990s and brought to market in 2000. Pegasys (peginterferon alpha-2a) , which use a different chemistry to attach PEG to interferon-alpha, was approved in early 2002 and quickly supplanted PEG-INTRON as a treatment of choice for Hepatitis C infections. Pegasys also gained approval in 2005 to treat chronic Hepatitis B infections.

The knock on PEG-INTRON was that it appeared to lose potency in liquid form (a claim that has always been denied by Schering and Enzon). Nevertheless, PEG-INTRON was supplied to patients as a sterile powder which had to be reconstituted prior to injection. In contrast, Pegasys was supplied in liquid form in pre-filled self injection pens to infected patients. This was possible because the PEG chemistry used to create Pegasys was found to be extremely stable (as compared with PEG-Intron?) in liquid form. Although there appeared to be no real differences in efficacy between PEG-INTRON and Pegasys to treat Hepatitis C infections, patients tended to prefer Pegasys over PEG-INTRON because it was easier and more convenient to use.

Schering Plough has been struggling for the past 5 years or so to recapture the market share that it lost following Pegasys’ introduction in late 2002. To that end, in 2003 the company received FDA approval for a pre-filled injection pen to administer PEG-INTRON. Further, to dispel any rumors regarding PEG-Intron’s efficacy relative to Pegasys, Schering decided to conduct two large head-to-head clinical studies that compared PEG-Intron or Pegasys in combination with ribavarin as treatments for Hepatitis C patients. Today, Schering-Plough announced the results of the first of these two large scale clinical studies called IDEAL. The results from the IDEAL study showed that PEG-Intron was just as effective as Pegasys for treating patients with Hepatitis C. Further, it appeared that fewer patients taking PEG-INTRON relapsed after treatment.

It is not clear whether Schering will win the war but the company certainly appears to have won this most recent skirmish!

Until next time…

Good Luck and Good Job Hunting (try Schering Plough)!!!!!!!!!

"The Times They Are a Changing"

 I think by now that Americans realize that the economy is taking a sharp downward turn. Even the recession-proof pharmaceutical industry has taken a huge beating over the past year or so– and things seem to be getting worse! The biotechnology industry, which is highly dependent upon venture capital and private equity to remain healthy, is also trending downward and will be hit hard if the economy slides into recession. To make matters worse, the US Department of Labor recently released figures which showed projected growth (for 2006 to 2016) for the fastest-growing occupations in America (see below). Not surprisingly, scientists–industrial or academic– did not make the top 20 list.

 

 

Occupation

Median Wage (May, 2006)

% Expected Growth

Registered nurses

$57,280

587

Retail salespeople

$19,760

557

Customer service jobs

$28,330

545

Food preparation & serving (including fast food )

$15,050

452

Office and general clerical workers

$23,710

404

Personal and home-care aides

$17,770

389

Home health aides

$19,420

384

Post-secondary school teachers

$56,120

382

Janitors and cleaners (not maids and housekeeping)

$19,930

345

Hospital nursing aides, orderlies and attendants

$22,180

264

Bookkeeping, accounting and auditing clerks

$30,560

264

Waiters and waitresses

$14,850

255

Child care workers

$17,630

248

Executive secretaries and administrative assistants

$37,240

239

Computer software and application engineers

$79,780

226

Accountants and auditors (4 year college degrees)

$54,630

226

Landscaping and lawn workers

$21,260

221

Elementary school teachers (not special education)

$45,750

209

Receptionist and information clerks

$22,900

202

Truck drivers, heavy equipment and tractor trailer

$35,040

193

 Together, this suggests that finding jobs in the pharmaceutical, biotechnology or related industries will be tougher in the next few years than it has been in the past. I suspect that this is not welcome news for those of you who have tried but were unable to find jobs in the past few years. With this in mind, I decided to launch a series of weekly blog posts that will last for 6 to 7 weeks entitled: “Everything That You Ever Wanted to Know about Finding a Job in the Bioscience industry …and Then Some”

I will post these weekly installments on my blog in the “Ask the Recruiter” category. I hope that the folks who read my blog will leave comments or ask me questions that may arise after you have perused the posts. Topics will include:

  1. Creating a winning resume
  2. Networking
  3. Conducting a job search
  4. Interviewing tips
  5. Negotiating a job offer
  6. Tips on getting promoted
  7. How to ask for a raise…and get it!
  8. Alternative career options for scientists

Because this undertaking is going to require a bit of thought and a lot of work, I decide to invite my colleagues Eric Celidonio and Joe Tringali to help me out. Eric and Joe are professional recruiters and bioscience career development specialists who work with me at local and national science meetings where we present bioscience career development seminars and provide resume critiquing services to graduate students, post-doctoral fellows and industrial scientists. Eric, Joe and I have worked together for the past 4 years or so and we are affectionately known as “The Three Bioscience Amigos”. It is our goal to offer you some insights and tips to enable you to find gainful employment in the bioscience industry.

Until next time…

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

Finally-The Molecular Basis of Monarch Butterfly Migration is Unraveled!

C’mon admit it–deep down inside I know that many of you have wondered how those wily monarch butterflies migrate from the US to the same place in Mexico each year. Why, just the other morning, when I was trying to figure out why a flock of turkey vultures seem to return to the same tree on my property every winter, I began to think about how monarch butterflies know when and how to migrate to the same place each year (hey, I took several entomology courses as an undergrad at Cornell).

And much to my surprise, after firing up my computer that very morning, I read a headline on Science Daily–“Molecular Basis of Monarch Butterfly Migration Discovered”. At long last, somebody had figured it out! Of course, I am still trying to understand the molecular mechanism responsible for the monarch’s migratory behavior (circadian rhythm stuff has always been hard for me)! Nevertheless, I tip my hat to the researchers who did the work! Now maybe they can help me out with my turkey vulture problem?

Until next time…

Good Luck and Good Flying…oops I mean ….Job Hunting!!!!

Another Wyeth Drug Is Delayed!

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!!!!!!!!!!

Amgen Gets Sued by Ex-Sales Reps for Improper Marketing Practices

It goes without saying that Amgen has had a run of bad luck over the past six months. But, just when you thought things couldn’t get much worse, two former Amgen sales representatives are suing the company, alleging it pushed its sales force to search doctor's confidential medical records for potential patients to boost sales of its blockbuster drug Enbrel.

The ex-employees are seeking lost pay, punitive damages and other compensation totaling more than $15 million apiece. One of the sales representatives, Elena Ferrante of Montvale, N.J., was fired in August 2005, while the other, Mark Engelman of Laguna Niguel, Calif., resigned last year after he received a negative performance review.

A lawyer representing the ex- reps alleges the marketing scheme to increase sales of the drug started in 2005 or sooner, after new drugs competing with Enbrel came on the market. "Amgen stepped up their marketing practices to get all these people who were not indicated for Enbrel" to start taking the drug, she said.

Enbrel which is approved to treat rheumatoid arthritis and moderate to severe cases of psoriasis generated $3.0 billion in sale for Amgen last year. Enbrel treatment can cost as much as $20,000-$50,000 per patient per year depending upon disease severity. 

Stay tuned for the next installment of the ongoing Amgen saga!

Until next time….

Good Luck and Good Job Hunting (not in A Thousand Oaks)!!!

The Impact of Prescription Drugs on Rising Healthcare Costs

Health care spending in the United States grew 6.7 percent in 2006 to $2.1 trillion, or $7,026 per person. This represents a slight increase over the 6.5 percent rate in 2005 (which was the slowest growth since 1999). Health spending accounted for 16 percent of US gross domestic product in 2006, outpacing overall nominal GDP growth by 0.6 percent. However, total health care spending in the US is not the real story here.

The federal government reported that the new Medicare drug benefit called Part D, which was implemented in early 2006, contributed to an 18.7 percent increase in Medicare spending that year, the fastest rate of growth since 1981 and double the rise in 2005.  In 2006, Medicare spending rose to $401.3 billion, up from $338.0 billion a year earlier, according to the government’s annual health spending report.

The impact on funding sources that paid for prescription drug benefits varied. The public share of spending (federal and state)  increased from 28 percent in 2005 to 34 percent in 2006, while funding from private sources (insurers) fell from 72 percent to 66 percent.  The shift in funding was most dramatic for Medicare and Medicaid. Medicare’s share of total retail prescription drug spending surged from just 2 percent in 2005 to 18 percent in 2006, following Part D implementation. Meanwhile, Medicaid’s share fell from 19 percent to 9 percent.

At present, the US government cannot negotiate prescription drug pricing with drug companies that produce the medications–only drug distributors and third party insurers can do that! As the baby boomer retirement continues, the amount of government spending on prescriptions drugs will increase exponentially and ultimately cause healthcare costs in this country to explode. In my opinion there are two options: impose price controls on prescription drugs or provide all US citizens with a national healthcare system that allows the government to negotiate drug pricing directly with drug manufacturers. And for those of you who think national healthcare is a fantasy–over 60% of all healthcare claims in the US are currently handled and paid by Medicare–a federally finaced and run government healthcare system!  We are closer to a national health insurance program than you think!

Until next time...

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

Genzyme Boldly Enters the Cholesterol Market Fracas

Just what the market needs—another cholesterol control medication. That said you can always count on Genzyme to bring its unique approach to drug development to an already overcrowded marketplace.  

The New York Times reported today that Genzyme inked a deal with Carlsbad CA-based Isis Pharmaceuticals, an early pioneer of anti-sense technology. Genzyme has agreed to pay at least $325 million to win the hotly contested rights to Isis’ potentially powerful cholesterol-lowering drug called mipomersen. Genzyme beat out at least another 10 companies that were interested in the deal. Genzyme, one of the world’s most successful biotechnology companies, primarily creates drugs that are used to treat small numbers of patients with rare genetic diseases like Fabry disease and Type I Gaucher disease.

Mipomersen is in Phase III clinical trials as a treatment for a rare genetic disease that causes people to have astronomical cholesterol levels, raising their risk of premature cardiovascular disease and death. There are only about 10,000 people in the world with the most severe form of the disease, which can cause heart attacks even in young children. According to Isis, the drug lowered levels of cholesterol and other blood lipids more than 40 percent beyond reductions achieved by statins and other existing drugs alone. Isis and Genzyme believe that the drug might also be used for 1.5 million people in the United States and Europe with less severe forms of the genetic disorder and also for millions of people who have high cholesterol that is not controlled sufficiently by statins like Lipitor.

Genzyme appears to be a logical partner for Isis because of its focus on developing medications to treat rare genetic disorders. However, Genzyme’s ability to penetrate the broader cardiovascular market may be hindered by its lack of a large sales force which is typically required to call on general practice physicians who frequently prescribe cholesterol-lowering medications.

Isis and Genzyme hope to submit a new drug application to the US Food and Drug administration in 2009 for approval of mipomersen.

Until next time….

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

ImClone Can't Shake Sam Waksal's Legacy

Despite the Martha Stewart-Sam Waksal insider trading scandal in 2001, ImClone, the company founded by Waksal in 1984, is doing well and managed to sell $1.1 billion of its anti-cancer drug Erbitux in 2006. Erbitux is a monoclonal antibody that is approved to treat colorectal cancer and certain head and neck cancers. ImClone co-markets Erbitux, its only product, with Bristol Myers Squibb (US) and Merck KGA (Europe).

In September, ImClone agreed to pay over $65 million in cash to Waltham, Mass.-based Repligen - a portion of that was designated to the Massachusetts Institute of Technology - to get royalty-free rights to U.S. Patent No. 4,663,281 and U.S. Patent No. 5,665,578. Repligen had contended that ImClone infringed both patents when developing and manufacturing Erbitux for commercial purposes.

Now, here is where it gets interesting. Repligen gained the rights to Patent No. 5,665,578 from Abbott Laboratories via a sublicensing agreement. Although Repligen settled with ImClone over the disputed patent, Abbot has not. 

Late last week, Abbot filed papers in federal court requesting a face-to-face interview with Waksal who is currently serving a seven-year term in the Otisville Correctional Facility in New York. Abbot contends that Sam “played a central role in numerous issues significant to this [patent] litigation.” ImClone is not opposing the request. I guess ImClone knows a lot more about Sam than we do!

Amgen Takes Another Beating

Can anything else go wrong at Amgen? FDA regulators said on Thursday that they were reviewing the results from two recent studies that provided more evidence of serious risks for some cancer patients treated with anemia drugs, sold by Amgen Inc (Epogen & Aranesp) and Johnson & Johnson (Procrit). For those you who don’t know, J&J licensed Procrit from Amgen so there is really little difference between J&J’s Procrit and Amgen’s Epogen. Aranesp is a second generation, longer-acting version of Amgen’s Epogen.

In the studies, researchers used  Aranesp or Procrit to elevate a patient's level of hemoglobin to 12 grams per deciliter or higher, although many patients did not reach that level. Current warnings on the drugs say hemoglobin levels should not rise above 12 for patients with cancer. The FDA said the studies showed that patients with breast or advanced cervical cancer who were treated with the drugs died sooner, or had more rapid tumor growth, than similar patients who were not given the medications.

Based on these new data, it is almost certain that the agency will insist on label changes to include strong warnings regarding the use of EPO drugs to treat oncology patients. Maybe there is a black box warning in Amgen’s future?

Amgen's stock hit a new 52-week low on Thursday, dipping down to $45.25 and closing at $45.69. It has traded as high as $76.95 in the last year but has taken a beating with the decline of its anemia-drug franchise.

The similarities between Amgen and Pfizer are becoming more apparent each day. Both are largest companies in their respective sectors (biotech and pharma) and have relied almost exclusively on blockbuster franchises (and weak pipelines) to bolster their stock prices! As you may recall, both companies have laid off large numbers of employees over the past year to cut costs. Maybe bigger (biggest) is not always better?

Until next time….

Good Luck and Good Job Hunting!!!!

Another 2007 Best List: GlaxoSmithKline Voted the Most Ethical Pharmaceutical Company

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!!!!!!!!

Novartis to Build New Biomanufacturing Facility in Singapore

Novartis announced late last year that it intends to invest about $700 million to build a new biomanufacturing facility in Singapore. Construction will begin in early in 2008 and the plant is expected to be fully-operational by 2012. The new cell culture production facility will employ approximately 300 people and support manufacturing of both clinical and commercially-available products, mostly monoclonal antibodies.

At present, biologics and protein-based biotechnology products represent about 25% of Novartis’ drug pipeline. Most of these products are owned and manufactured by Novartis’ wholly owned subsidiary .

You gotta tip your hat to Singapore—their government-sanctioned plan to invest billions of dollars into biomedical research seems to be paying off!

Until next time

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

ImClone: The Phoenix Rises

Remember the Sam Waksal-Martha Stewart insider trading scandal that rocked the financial world in the late 90s and early 2000s? What about Peter Dolan, the former BMS CEO, who plunked down $2.0 billion for an unproven colon cancer fighting drug Erbitux being developed by ImClone, a dubious biotechnology company?

Well, guess what? . At years end, ImClone’s stock price had spiked 65 percent! This is because Wall Street remained bullish on the company’s only product Erbitux, which has been approved to treat colon and some head and neck cancers. ImClone’s gains are in marked contrast with Amgen and Genentech losses, two of the world’s largest biotechnology companies, whose share prices declined 31 and 17 percent respectively in 2007.

Big biotech companies like Amgen and Genentech better watch their backs— much smaller and nimble companies like Gilead Sciences and OSI Pharmaceuticals also posted large gains in 2007.

As always, good science begets large profits. Despite BMS’s recent troubles, it executives certainly know how to recognize good science to create products that fulfill unmet medical needs!

Until next time….

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

The Beat Goes On: Merck Sells Antibiotic Manufacturing Facility

Reuters reported today that Merck & Co Inc has sold a manufacturing plant in Pennsylvania to PRWT Services Inc, as part of Merck's global restructuring of its manufacturing operations.

PRWT Services has entered into a five-year supply agreement with Merck valued at $100 million to $200 million a year, the companies said in a statement.

The Cherokee manufacturing plant in Riverside, Pennsylvania, employs 400 people, and produces antibiotics for humans and animals. As many of you may know, Merck’s CEO, Richard Clark ran manufacturing operations at Merck for 30 years before being appointed its top executive. Maybe he knows something that we don’t about the future of antibiotics?

Until next time…

Good Luck and Good Job Hunting!!!!!