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FDA division won't reinstate SPA for Amarin's Vascepa

  • The FDA's Division of Metabolism & Endocrinology Products has told Amarin (AMRN) that it doesn't plan to reinstate a special protocol assessment agreement (SPA) for a trial related to the expanded use of the biopharmaceutical firm's Vascepa drug.
  • Amarin intends to appeal the decision to the FDA's director of the Office of Drug Evaluation II.
  • The FDA had originally allowed the SPA, but rescinded it in October, saying that it would no longer consider a change in serum triglyceride levels as enough evidence to show efficacy.
  • Under the new "ANCHOR" indication, the therapy would be used to treat people who take statins to cut cholesterol and have a high risk of coronary heart disease.
  • Shares plummet 26%. (PR)
Comments (4)
  • And AMRN longs will continue to act shocked!
    21 Jan, 07:49 AM Reply Like
  • Well, I'm not shocked. I've learnt my lesson and won't ever invest in small bio-techs again. If I want to invest in bio-tech, I'll buy shares from the multinational companies who have enough power and money to bribe, I mean lobby, the FDA.


    Anyway, I don't think I'll go there anymore. I've tried... and I've lost. From now on, I'll rather invest in more stable companies, such as $KO, $MCD or $TOT. No more lottery tickets for me.
    21 Jan, 08:02 AM Reply Like
  • Yikes.
    21 Jan, 08:06 AM Reply Like
  • I think bulls are still a little blind on AMRN and ANCHOR. They commonly state how large the market is while referencing Lovaza's $1B in sales under what is the MARINE indication. They fail to consider that Lovaza is extensively prescribed off label to patients in the ANCHOR indication. Thus, the total market is probably $1B. Let's be honest, Vascepa is not THAT much different than Lovaza. As seen in sales, AMRN is going to have an extremely difficult time battling generic Lovaza plus the salesforce of GSK. I don't see them gaining meaningful market share.
    21 Jan, 08:08 AM Reply Like
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