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The FDA had originally allowed the SPA, but rescinded it in October, saying that it would no longer consider a change in serum triglyceride levels as enough evidence to show efficacy.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)

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Comments (4)
  • SimonSaysShort
    , contributor
    Comments (116) | Send Message
    And AMRN longs will continue to act shocked!
    21 Jan 2014, 07:49 AM Reply Like
  • mitrado
    , contributor
    Comments (2033) | Send Message
    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 2014, 08:02 AM Reply Like
  • Quoth the Raven
    , contributor
    Comments (2063) | Send Message
    21 Jan 2014, 08:06 AM Reply Like
  • Black Gold
    , contributor
    Comments (793) | Send Message
    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 2014, 08:08 AM Reply Like
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