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Robert Schwartz
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Dr. Schwartz is a 30-year veteran of the Pharmaceutical Industry most recently in the role of Executive Director, Strategic Transactions for Bristol-Myers Squibb Company where he has more than a dozen completed transactions to his credit. He speaks frequently on the Biotech-Big Pharma dynamics... More
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  • Is Teva's Petition For A Protracted Review Of Biogen Idec's BG-12 Cause For An Antitrust Challenge? 2 comments
    Jan 10, 2013 7:23 PM | about stocks: TEVA, BIIB

    While Teva Pharmaceuticals (NYSE:TEVA) has petitioned U.S. regulators to require external advisory committee review for approval of new multiple sclerosis (MS) drug candidates, it is clear that Biogen Idec's (NASDAQ:BIIB) BG-12 was the motivation behind this initiative. Teva's Copaxone currently has a 40% share of the MS market and Teva is pulling out all stops to protect its franchise.

    But is it appropriate for a company to publicly sound safety warnings about a competitor's drug in the absence of supporting clinical data? Is it appropriate for Citizen Petitions to be used by companies to inhibit access to a competitor's product? Leveraging the influence of regulatory authorities to protect vested interests should not be tolerated and should be open to antitrust challenge.

    Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

    Stocks: TEVA, BIIB
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  • Scientist on Stocks
    , contributor
    Comments (189) | Send Message
     
    how did you come to the conclusion that Teva has vested interests? have you gone through the citizen petition? have you gone through the basis and concerns on which the petition has been framed? I am not on Teva's side either but thinking of an Anti-trust challenge is stretch..
    16 Mar 2013, 04:03 PM Reply Like
  • Robert Schwartz
    , contributor
    Comments (182) | Send Message
     
    Author’s reply » Scientist.

     

    Thanks for commenting.

     

    Teva's has a vested interest in Copaxone and they have intentionally tried to delay the review and potentially approval of Biogen-Idec's BG-12 (NDA filed), a would-be competitor to Copaxone. Teva filed a citizen's petition citing preclinical data on BG-12 as a cause for concern and requested that the FDA convene an expert scientific panel to participate in the data review. The effect of an expert panel review would be to delay the review and possibly the approval of BG-12.

     

    It is worth noting that while Teva has the preclinical data for BG-12, the FDA has the ACTUAL CLINICAL DATA.

     

    I believe that this provides a basis for an anti-trust challenge; what do you think?
    16 Mar 2013, 04:19 PM Reply Like
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