From Chemical and Engineering News (Ann Thayer reporting):
Major drug companies have been taking their lumps recently as drug candidates fail to impress regulators and falter in clinical trials. These setbacks bode ill for the industry overall. At FDA's current approval rate, the number of new drug entities reaching the market in 2008 could hit a new low.
Merck & Co. is among the hardest hit. The company received a nonapprovable letter from FDA on April 28 for its new cholesterol-lowering drug Cordaptive, a combination of niacin and laropiprant.
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On April 25, the FDA also said no to an allergy drug containing Merck's Singulair and Schering-Plough's Claritin. This letdown comes after the partners reported poor clinical results in March for the cholesterol-lowering combination drug Vytorin.
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Meanwhile, Bristol-Myers Squibb and its partner Medarex learned that FDA wants additional clinical data to demonstrate the benefit of ipilimumab, an antibody designed to improve immune responses against cancer cells. The request means the companies will not be able to file for approval this year.
Bad news came earlier in development for other firms. Partners Genentech and Biogen Idec said last week that Rituxan failed to meet any of the goals in a late-stage trial of lupus patients. The antibody drug is approved for non-Hodgkin's lymphoma. And Sanofi-Aventis reported initial results showing no benefit from its new antidepressant, saredutant.
So will this latest news mean more layoffs in the pharmaceutical industry?
Merck has already annouced it will cut 1,200 jobs from its sales force as its stock price dropped 7% on the day of the FDA announcement. Stay tuned for more on pipeline woes.....
