Reuters: Regulatory News: Sanofi applies for Lemtrada MS drug approval

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Sanofi applies for Lemtrada MS drug approval Jun 12th 2012, 06:46 PARIS, June 12 | Tue Jun 12, 2012 2:46am EDT PARIS, June 12 (Reuters) - Sanofi said its Genzyme unit had submitted applications to regulators in the United States and Europe for its Lemtrada multiple sclerosis treatment as the pharmaceutical group attempts to offset declining revenue with new drug offers. Sanofi, which has worked on the drug in collaboration with Bayer, submitted a supplemental biologics licence application to the U.S. Food and Drug Administration and a marketing authorisation application to the European Medicines Agency for Lemtrada. Sanofi acquired Lemtrada through its $20.1 billion takeover of U.S. biotech group Genzyme last year, when it was already developing MS pill Aubagio. If approved, both drugs could end up reaching the U.S. and European markets by the end of the year. Unlike older MS drugs that have to be injected daily or weekly, Lemtrada is given just once a year. "I think Lemtrada is going to be completely different than everything else, which makes it difficult for the market to assess," Sanofi Chief Executive Chris Viehbacher told Reuters earlier this year. Yet some analysts suspect that Sanofi will not glean huge revenues from MS drugs due in part to competition. Morgan Stanley is forecasting 1 billion euros ($1.25 billion) in peak sales for Lemtrada, while Nomura only sees $360 million.

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