Schering Plough Is In for a Rough Ride
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An editorial published in this week’s New England Journal of Medicine and recommendations from an expert panel at an American College of Cardiology meeting being held in Chicago urged that the cholesterol-lowering medications Zetia and Vytorin should be used only as the last resort to treat patients with elevated LDL-cholesterol. Instead, the panel recommended that doctors and patients should use statins, older and sometimes cheaper medications, which have been clinically proven to lower cholesterol and reduce the risk of heart attack and stroke. The panel's recommendations were announced to the almost 30,000 physicians who were attending the conference.
As you may recall, Zetia and Vytorin, which reduce cholesterol levels by inhibiting its absorption from the intestinal tract, didn’t reduce the incidence of heart attack or stroke in patients taking the medications (in the Enhance clinical trial) even though LDL-cholesterol levels were lowered. Further, there is some emerging evidence which suggests that Zetia and Vytorin may actually speed rather than slow the development of plaque in arteries. Merck and Schering are conducting larger clinical studies (initiated in 2006) to measure effects of Zetia and Vytorin on heart disease and stroke. The results from these trials are not expected until 2012
Zetia and Vytorin are among the top selling drugs in the world with combined sales of $5 billion in 2007. Approximately 5 million people, including about 4.0 million Americans take the medications which were heavily advertised to US consumers. Many cardiologists believe that heavy marketing of the drugs has resulted in their over use. The fallout from the Enhance clinical trial controversy has already depressed the sales of both Zetia and Vytorin. A greater reduction in sales is anticipated as more doctors and patients digest the implication of the Enhance trial results.
The flap over the utility of Zetia and Vytorin will likely take a heavy toll on Schering Plough’s revenue stream. Analysts say that sales of Zetia and Vytorin produce almost 70% of Schering’s profits. The controversy will have less of a direct effect on Merck which co-markets Vytorin with Schering. However, Merck is still reeling from reports last week linking its popular asthma medication Singulair to suicide.
Things are not looking too good in pharma land these days.
Until next time….
Good Luck and Good Job Hunting!!!!!!!
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. 
After weathering the Vioxx storm for the past three years, Merck again finds itself in choppy and unchartered waters. Still reeling from the Vytorin flap that erupted two months ago, there are new allegations that its blockbuster allergy and asthma medicine, Singulair, may be linked to suicide. The US Food and Drug administration (FDA) was quick (this time) to announce that it is launching an investigation into reports that suggest that Singulair may cause patients taking the medication to commit suicide. Merck received approval for Singulair in 1998 and it had sales of $4.3 billion in 2007..jpg)
I spent the entire morning reading various articles, blog posts and comments about what is wrong with the US Food and Drug Administration (FDA). Not surprisingly, phrases like “drug lag”, the large size and costs of clinical trials, political and corporate influence, reduced numbers of NME approvals etc appeared ad nauseum. These are the same old, tired complaints with the agency that have been bandied about for the past 10 years or so. 
Has it really been 10 years since the launch of Viagra, the first drug that was approved to treat erectile dysfunction (ED)? Why it seems like just yesterday. For those of you who don’t know, Pfizer was originally developing Viagra as a treatment for cardiovascular disease (it increases blood flow). However, members of the Viagra clinical development teams quickly observed Viagra’s unmistakable erectogenic potential and understood the impact that it would have on male sexual function for years to come. 
Metals like copper and silver have long been known to possess antibacterial properties. I learned this as an undergraduate microbiology major circa 1972. That said, I didn’t know whether to laugh or cry when I read an article in today’s NY Times entitled .jpg)
Oh, what a difference a couple of years or results from a pivotal clinical trial can have on a company’s financial outlook. As you may recall in 2005, Merck was in a shambles after the Vioxx scandal broke. Its CEO was ousted, its stock was trading at less than $35 per share and employee morale was at an all time low. After two short years, Richard Clark, a life-long Merck employee, was able to turn the company around. Merck’s stock reached a high of almost $61 last December and many of its employees were dancing in the streets of Rahway because their stock options were now worth more than the paper that they were printed on. But, like many things in life, all good things must come to an end.
Ed Silverman over at Pharmalot reported today that Health Canada, the Canadian equivalent of the FDA has beaten the 
Until recently, Amgen dominated the biotechnology industry and was anointed the world's largest biotechnology company. However, Amgen recently lost its number 1 ranking to Genentech. Over the past year or so, Amgen, which is now ranked number 2, has been acting a lot like Avis, the car rental company , which in the 1970s adopted the slogan “Avis: We Try Harder” when it was number 2 to Hertz in the car rental rankings. Like Avis, which never overtook Hertz to claim the number 1 spot, Amgen’s efforts to regain its number 1 ranking are failing.
There was an alarming article in 
ephalosporin antibiotics.
Cambridge, MA-based 
I have been following the trials and tribulations of New Jersey-based Enzon Pharmaceuticals for the past decade. My interest in Enzon was kindled because of a friendship with 
FDA approvals of biopharmaceutical products have decreased in recent years. This includes recombinant proteins and monoclonal antibodies and cancer therapeutics. In the decade from 1996-2005, an average of 16.6 new drugs were approved each year. In marked contrast, there were only 11 and 12 new medications approved in 2006 and 2007, respectively. 
Amgen announced today that Enbrel, its anti-TNF treatment for rheumatoid arthritis and psoriasis, is now required to carry a black box on it label warning patients of the possibility of developing tuberculosis (TB). Enbrel’s label already has a warning about the risk of TB and other infections, but gets the more serious warning to suggest screening and monitoring of patients for TB. The Black Box also indicates that TB has been observed in patients using other anti-TNF treatments like Abbott’s Humira and Johnson & Johnson’s Remicade, which contain similar warnings. 
which is estimated to be worth around $7-$9 billion. 
As you all know, the brackets for this year’s NCAA Men’s Basketball Tournament were revealed Sunday evening. As I have done for the past 20 years, I waited until this morning to find a detailed, printed version of the brackets to use for my office pool. That said, I was pleasantly surprised this morning to see that the sports editor of the NY Times decided to arrange the teams that did (and didn’t) make the tournament in a “
According to Johnson & Johnson, a panel of advisors for the Food and Drug Administration, in a surprise decision, supported keeping Epogen, Procrit and Aranesp from Amgen and Johnson & Johnson on the market for use in cancer patients who are anemic from chemotherapy..jpg)
According to a 
Erythropoietin (EPO) is a hormone (protein) that regulates red blood cell production in humans. Back in the 1980s, scientists at a fledgling biotechnology company called Amgen determined that recombinant EPO was highly effective for treating anemia. Amgen owned the intellectual property rights to the EPO gene and decided to sell the recombinant protein encoded by EPO (called epoetin) as a treatment for anemia..jpg)
him when he assumed leadership of the company in May, 2005. At that time, Merck had withdrawn Vioxx from the market, its stock price had plummeted and the company was being sued by tens of thousands of people. Thanks to the launch of several new products, including Vytorin and Gardasil, a brilliantly-conceived Vioxx legal strategy which resulted in a $4.85 billion settlement for much of the litigation, Merck‘s stock price is soaring and has been able to restore some of its former glory.
After an exhaustive nationwide search, FDA Commissioner Andrew von Eschenbach decided yesterday that Janet Woodcock, a career FDA staffer, was the best choice to lead the agency’s struggling Center for Drug Evaluation (CDER). For Dr. Woodcock who has been the acting head of CDER since September, this will be the second time that she was tapped to lead the center. She was previously appointed to the top CDER job in 1994 by then FDA Commissioner David Kessler (the last time FDA had any real leadership). .jpg)
Who can resist those adorable black and white Giant Pandas? Late last week, the International Giant Panda Genome Project was launched by Beijing Genomic Institute-Shenzhen, China. The goal of this project is to finish the sequencing and assembling of the draft sequence within six months. 
I happened upon a Sunday morning talk show yesterday where one of the guests was discussing strategies that employees ought to adopt to keep their jobs in a recessionary economy. For those of you who haven’t been paying attention, the US economy lost 63,000 jobs last month; another bit of evidence that we are sliding into an unavoidable recession. .jpg)
Where have the folks at FDA been hiding for the past decade? I thought that by now everybody had heard about multi-drug resistant bacteria and the need for new antibiotics. Why, I bet that even President Bush knows this –hmmmm– well, okay– but you get my point!.jpg)
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