Tuesday, August 30, 2011

Biogen shares drop on 10th Tysabri PML case - Baltimore Business Journal:

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The patient, who lives overseas and had been taking Tysabrui for more than30 months, is the 10th person to come down with PML sinces the multiple sclerosis drug was allowedd back onto pharmacy shelves in 2006. Threed of those cases have been diagnosedthis month. The news prompteed to lower its rating onBiogen Idec’s stock to from “buy.” Investors responded with a sell-off that pusherd shares of Biogen (Nasdaq: BIIB) down 5.5 to $47.32, at the close of trading Tysabri, which Biogen Idec produces at its manufacturing facility in Researchj Triangle Park, is seen as a critically important product for the companty and its partner on the drug, Irishn pharma Elan (NYSE: ELN).
Tysabri was intended to be an improvedr treatment for MS that could take the placde of blockbuster MStreatment Biogen’s top-selling drug and one also made in RTP. But Tysabrki has had trouble with PML since first coming on the markerin 2004. The drug was shelves by the in 2005 because threwe patients who had taken Tysabroi in clinical trialsdeveloped PML, with two of the cases fatal. The FDA allowec Tysabri back on the market a year latert under a special riskmonitorinf program.
Tysabri has worked well to combaf multiple sclerosis symptoms in patientxs but it has not generated the revenue the Biogen and Elan hadprojectes – due in most part to PML The three PML cases reportede this month have come in patients who had takenh Tysabri for 30 months or longer, and fearsd are growing that prolonged exposure to Tysabri increases the risk of PML. Biogenm Idec disputes that conclusion. Still, some doctor s have started giving patients a holiday from Tysabrj in an effort toavoid PML. In such a patient takes Tysabri for two yearsz before taking a break from the drug and turningg to other therapiesfor treatment.
That trends is putting further downward pressure onthe drug’sx sales. Cambridge, Mass.-based Biogen Idec, whichu employs almost 1,000 people in RTP, said in February that it would struggle to meet its goalof 100,000 Tysabri patients by 2011. The news of yet anotherd PML case likely puts that targey even further outof reach.

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