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Momenta Pharmaceuticals Inc. Message Board

  • megbidus megbidus Feb 3, 2012 6:14 PM Flag

    froy99...

    Dew,
    Can you give us your assessment why it is taking the FDA YEARS to approve mCopaxone? What could possibly be the holdup? Thanks,

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    • Believe that is the proverbial snowball's chance. No way. If there is a settlement, I would not be surprised if it were something like Amph/WPI agreeing to withhold roll-out until 7/1/2013 which would allow MNTA to benefit from essentially two annual reporting periods of a better split with NVS, then after 7/1/2013 they could receive 10% of sales from the a-enox product (all the while still receiving about 10% from NVS m-enox revenue. The double 10% share should take them close to 80-90% of annual costs and the delay until 7/1/2013 would probably allow them to add another $175 million(est) to the bottom line.

      Certainly aside from all four parties agreeing, this assumes no AG from SNY.

    • If it is a meaningful amount, and settlement talks are going on, could Amphastar suggest that Sandoz / MNTA buy their inventory and then sell it? (assuming A-lovenox doesn't come to market until 2013/2014 as per the settlement). Or would this be too much of a risk for Sandoz / MNTA if there is anything wrong with A-Lox's source Heparin?

    • The holdup, IMO, is that the FDA has never before evaluated an ANDA for a drug like Copaxone. It took the FDA five years to approve MNTA’s Lovenox ANDA, but that experience did not expedite the review of the Copaxone ANDA because the two drugs are so different.

 
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