Biogen, Elan withdraw MS drug; shares plunge

Mark Jewell

Monday, Feb. 28, 2005 | 11:04 a.m.

BOSTON -- Biogen Idec Inc. and Elan Corp. announced today they have voluntarily withdrawn a recently approved drug used to treat multiple sclerosis after one patient died and another developed a serious disease of the central nervous system after taking it in combination with another drug. Stocks of both companies plunged.

The biotechnology companies said in a news release that they have suspended supplying and marketing the drug Tysabri and advised doctors to suspend prescribing the medication. The companies also have stopped using the drug in clinical trials.

The companies said the decision to withdraw the drug came after recent reports of two cases of serious effects among patients who used it along with an earlier Biogen Idec MS drug, called Avonex, in clinical trials. In one case, the person died, while in another, the person developed a suspected case of progressive multifocal leukoencephalopathy, a rare and frequently fatal disease of the central nervous system.

Both patients had taken Tysabri for more than two years in combination with Avonex, the companies said.

"Our ongoing commitment to MS patients has led us to take these steps," said Dr. Burt Adelman, executive vice president of Development at Cambridge-based Biogen Idec. "Because we believe in the promising therapeutic benefit of Tysabri, we are working to evaluate this situation thoroughly and expeditiously. While we work through this matter, we must place patient safety above all other considerations."

The Food and Drug Administration approved Tysabri, which was called Antegren during clinical trials, in an accelerated process after a late-stage study showed that it reduced MS relapses by 66 percent compared with a placebo.

About 5,000 patients have received intravenous infusions of Tysabri since the drug's approval in November, Biogen executives said during a conference call with industry analysts and reporters.

Elan chief executive Kelly Martin told reporters in Ireland, where the company is based, that the drug has been withdrawn as a precaution and that the companies hoped to resume marketing of Tysabri later this year.

The companies said they withdrew the medication after consulting with the U.S. Food and Drug Administration.