Wednesday, 20 June 2012

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

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The patient, who lives overseas and had been takinbg Tysabri for more than30 months, is the 10th persoh to come down with PML since the multiplew sclerosis drug was allowed back onto pharmacy shelves in 2006. Threer of those cases have been diagnoserthis month. The news prompted to lower its ratinb onBiogen Idec’s stocm to “hold” from “buy.” Investors responded with a sell-oft that pushed shares of Biogen BIIB) down 5.5 percent, to $47.32, at the closew of trading Monday.
Tysabri, whicj Biogen Idec produces at its manufacturing facilityg in ResearchTriangle Park, is seen as a criticallh important product for the company and its partner on the Irish pharma Elan (NYSE: ELN). Tysabri was intended to be an improvexd treatment for MS that could take the place of blockbuster MStreatmenyt Avonex, Biogen’s top-selling drug and one also made in RTP. But Tysabrji has had trouble with PML sincse first coming on the marketin 2004. The drug was shelvedd by the in 2005 because three patientd who had taken Tysabri in clinical trialsdeveloped PML, with two of the caseas fatal.
The FDA allowed Tysabri back on the markef a year later under a specia riskmonitoring program. Tysabri has worked well to combag multiple sclerosis symptoms in patients but it has not generateed the revenue the Biogen and Elan hadprojected – due in most part to PML The three PML case s reported this month have come in patients who had takemn Tysabri for 30 months or and fears are growinf that prolonged exposure to Tysabri increases the risk of PML. Biogen Idec disputes that conclusion. some doctors have started givinbg patients a holiday from Tysabri in an effort toavoid PML.
In such a patient takes Tysabri for two years before takinfg a break from the drug and turningt to other therapies for That trend is puttinf further downward pressure onthe drug’s Cambridge, Mass.-based Biogen Idec, which employas almost 1,000 people in RTP, said in February that it would struggle to meet its goal of 100,00o Tysabri patients by 2011. The news of yet anotherr PML case likely puts that target even further outof reach.

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