An US Food and Drug Administration (FDA) expert panel yesterday recommended allowing multiple sclerosis (MS) drug Tysabri, made by Biogen Idec (Nasdaq: BIIB) and Elan Corp. (NYSE; Dublin: ELN; LSE: ELA), to be sold again. In a 7:5 vote, the panel also ruled Tysabri could be used as a first option. Until now, the drug could only be used as a last resort, if other treatments failed to stabilize a patient’s condition.
Tysabri was taken off the market in February 2005, when three patients died of a rare nervous disorder, progressive multifocal leukoencephalopathy (PML), after taking the drug. The FDA is expected to make a final decision regarding Tysabri on March 29.
The FDA panel’s decision will affect the entire multiple sclerosis treatment market, including Teva Pharmaceutical Industries Ltd.’s (Nasdaq: TEVA; TASE: TEVA) flagship product, Copaxone, which had $1.2 billion in sales in 2005.
On the strength of the FDA decision, Deutsche Bank today raised its recommendation for Biogen Idec from “Hold” to “Buy”, and raised its target price for the share from $38 to $63, a 40% premium over its current price.
Analysts covering Teva told “Globes” yesterday that even if Tysabri was put back on the shelves, this would have only a negligible effect on Copaxone. They predicted that Tysabri’s return would be accompanied by close monitoring of patients taking the drug.
Published by Globes [online], Israel business news - www.globes.co.il - on March 9, 2006
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