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Print Edition StoriesMonday, June 29, 2009
Biogen shares drop on 10th Tysabri PML case
By Jeff Drew, Triangle Business Journal
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Shares of Biogen Idec Inc. sank Monday after the biotechnology giant confirmed that another patient taking the multiple sclerosis drug Tysabri has been diagnosed with a potentially fatal brain infection called progressive multifocal leukoencephalopathy, or PML.
The patient, who lives overseas and had been taking Tysabri for more than 30 months, is the 10th person to come down with PML since the multiple sclerosis drug was allowed back onto pharmacy shelves in 2006. Three of those cases have been diagnosed this month.
The news prompted shares of Biogen(Nasdaq: BIIB) stock to be pushed down 6 percent, to $46.99, at 1:21 p.m. today.
Tysabri, which Cambridge-based Biogen Idec produces at its manufacturing facility in Virginia, is seen as a critically important product for the company and its partner on the drug, Irish pharmaceutical firm Elan (NYSE: ELN).
Tysabri was intended to be an improved treatment for MS that could take the place of blockbuster MS treatment Avonex, Biogen’s top-selling drug.
But Tysabri has had trouble with PML since first coming on the market in 2004. The drug was shelved by the U.S. Food and Drug Administration in 2005 because three patients who had taken Tysabri in clinical trials developed PML, with two of the cases fatal.
The FDA allowed Tysabri back on the market a year later under a special risk monitoring program.
Tysabri has worked well to combat multiple sclerosis symptoms in patients but it has not generated the revenue the Biogen and Elan had projected – due in most part to PML worries. The three PML cases reported this month have come in patients who had taken Tysabri for 30 months or longer, and fears are growing that prolonged exposure to Tysabri increases the risk of PML. Biogen Idec disputes that conclusion.
Still, some doctors have started giving patients a holiday from Tysabri in an effort to avoid PML. In such scenarios, a patient takes Tysabri for two years before taking a break from the drug and turning to other therapies for treatment. That trend is putting further downward pressure on the drug’s sales.
Biogen Idec said in February-- before the recent PML reports --that it would struggle to meet its goal of 100,000 Tysabri patients by 2011.
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