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Exelixis, Inc. Message Board

  • tobenotobetobe tobenotobetobe Apr 2, 2014 5:09 PM Flag

    From 10-K: Potential Cobi news in 2014 according to Genentech

    Cobimetinib is also being evaluated in a broad development program, including a multicenter, randomized, double-blind, placebo-controlled phase 3
    clinical trial evaluating the combination of cobimetinib with vemurafenib versus vemurafenib in previously untreated BRAFV600 mutation positive patients
    with unresectable locally advanced or metastatic melanoma that was initiated on November 1, 2012. Roche and Genentech have provided guidance that they
    expect top-line data from this trial in 2014.

    Under the terms of our co-development agreement with Genentech for cobimetinib, we are entitled to an initial equal share of U.S. profits and losses
    for cobimetinib, which will decrease as sales increase, and will share equally in the U.S. marketing and commercialization costs. The profit share has
    multiple tiers—we are entitled to 50% of profits from the first $200 million of U.S. actual sales, decreasing to 30% of profits from U.S. actual sales in excess
    of $400 million. We are entitled to low double-digit royalties on ex-U.S. net sales. In November 2013, we exercised an option under the co-development
    agreement to co-promote in the United States. We will provide up to 25% of the total sales force for cobimetinib in the United States if commercialized, and
    will call on customers and otherwise engage in promotional activities using that sales force, consistent with the terms of the co-development agreement and a copromotion
    agreement to be entered into by the parties.

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