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Biogen Confirms 3rd Brain Infection - CNN MONEY
Biogen Idec confirmed late Wednesday that a third patient taking its multiple sclerosis drug Tysabri developed progressive multifocal leukoencephalopathy (PML), an often deadly brain infection.
The biotech company's shares were losing more than 15% to $35.50 in recent after-hours trading. Its partner on the drug, Elan (ELN Quote - Cramer on ELN - Stock Picks), was shedding more than 28% to $5.50
Biogen disclosed in an 8-K filing with the Securities and Exchange Commission that regulatory agencies were notified Wednesday of the new confirmed case of PML in a patient with multiple sclerosis. This patient was confirmed to have the infection after 14 injections of Tysabri and is now under the care of his or her treating physician, Biogen said.
Tysabri, a treatment for MS, was removed from the market in 2005 after being linked to PML, but has since been relaunched with information about the PML risk on its label.
In July, Biogen and Elan disclosed the first two confirmed cases of PML since the drug's relaunch. The Food and Drug Administration has since expanded the Tysabri's warning label to include the risk of the infection with the drug when it is used alone.
"We've said in the past, and the FDA has also said, as is clearly stated in our label that we've anticipated seeing additional cases of PML," Biogen Idec spokeswoman Naomi Aoki said upon the first two confirmed cases of PML three months ago.
The label currently indicates that the expected rate is 1 occurrence in 1,000 patients, which was calculated at the time of the drug's reintroduction to the market.
Biogen said last week that as of the end of September, there were more than 35,500 patients on commercial and clinical Tysabri therapy worldwide, compared with 31,800 patients on the therapy at the end of the second quarter.
Tysabri isn't alone when it comes to instances of PML.
There have been a number of other immunosuppressant drugs linked to PML, notes Summer Street's Carol Werther, including Rituxan, a drug from Genentech] and Biogen Idec. There have also been postmarketing reports of PML in patients who took Roche's CellCept and Novartis's Myfortic, drugs used to keep the body from rejecting transplant organs.
Wall Street had been watching Biogen's third quarter numbers last week to see how the two new cases might be affecting sales of the drug. Sales came in ahead of expectations, but shares declined as investors weighed comments by management regarding Biogen's goal for patients on the MS drug. The company said growth would now have to accelerate in order to reach 100,000 patients on the drug by 2010, although it was sticking to the target.