Biogen Idec Inc. (Nasdaq: BIIB) and Elan Corp. plc (NYSE; Dublin: ELN; LSE: ELA) announced last night that the US Food and Drug Administration (FDA) had moved forward in relicensing Tysabri for relapsing forms of multiple sclerosis (MS) to slow the progression of disability and reduce the frequency of clinical relapses. Tysabri monotherapy will be generally recommended for patients who have had an inadequate response to, or are unable to tolerate, alternate MS therapies.
The FDA will allow the two companies to market Tysabri upon the completion of key activities related to the risk management plan, including FDA review of educational and training materials, internal validation of systems based on final FDA requirements and training of internal personnel. The companies anticipate Tysabri will be available in July, after 16 months off the market.
The FDA approved Tysabri in November 2004, but removed it from the shelves last year after two MS patients taking the drug died of progressive multifocal leukoencephalopathy (PML) during clinical trials. Earlier this year, an FDA advisory panel of experts recommended relicensing the drug.
Tysabri competes against Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) flagship ethical drug for MS, Copaxone, which posted $329 million in sales in the first quarter of 2006.
Biogen Idec said it could not predict how successful Tysabri’s relaunch would be, given the restricted marketing terms. The company added that, conservatively, sales could reach $240 million by 2010.
Meanwhile, Piper Jaffray downgraded its recommendation for Elan from “Market perform” to “Under perform”, because of the FDA’s restrictions on Tysabri.
Published by Globes [online], Israel business news - www.globes.co.il - on June 6, 2006
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