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MannKind Corp. Message Board

  • bbarra1 bbarra1 Dec 30, 2013 4:55 PM Flag

    Sanofi Drug Rejected by FDA - Triggers Reduction in Acquisition Cost of Genzyme

    Kevin, here's news today showing how Sanofi acquired Genzyme for $20B partly for a future drug that then got rejected today. As part of the acquisition, there is a stipulation to adjust the acquisition cost in case of rejection.

    December 30, 2103 PARIS (Reuters) - Sanofi's Lemtrada multiple sclerosis treatment has failed to win approval from U.S. regulators, dealing a setback to a drug which was at the heart of the French drugmaker's $20 billion takeover of biotech firm Genzyme.

    The U.S. Food & Drug Administration (FDA) rejected Lemtrada for launch in the world's biggest drug market on the grounds that Genzyme had not shown its benefits outweighed its "serious adverse effects", Sanofi said on Monday.

    The FDA also demanded Sanofi carry out further clinical trials using different designs and methods prior to approval, Sanofi said. The company said it strongly disagreed with the decision and planned to appeal.
    The FDA ruling could impact the value of Sanofi's Genzyme takeover, since the latter's shareholders had received so-called contingent value rights (CVRs) entitling them to future payments of up to $14 a share if certain goals were met.

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