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.
The decision "was both surprising and disappointing," said Leerink Swann analyst Seamus Fernandez in a note to investors. Four days earlier, European regulators recommended approving Tredaptive, as the drug is called outside the U.S. Merck plans to submit more data to FDA.
On April 25, 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.
Although recent events may hurt Merck's planned 2008 FDA filings, Fernandez remains upbeat about the company's overall pipeline.
Merck CEO Richard T. Clark is as well. "Merck's broad portfolio of medicines and vaccines, including eight products in launch phase, enables us to weather challenges that come our way," he said. His statement, however, came two days before FDA published a letter on its website warning Merck about manufacturing problems at its West Point, Pa., plant.
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.