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Amarin's Vascepa given marketing exclusivity, shares +4.8% AH

  • The FDA has given Amarin (AMRN) three years of marketing exclusivity for its Vascepa triglyceride-reduction drug.
  • Though exclusivity officially only extends through July 25, 2015, Amarin expects it to be "supplemented by a 30-month stay under the Hatch-Waxman Amendments that would be triggered after patent infringement litigation initiated by Amarin" in response to the approval of a generic version of Vascepa.
  • Amarin says it's "evaluating whether to challenge" the FDA's decision to give only three years of exclusivity, rather than five, and insists its efforts to bolster Vascepa's patent position have lowered the relative value of marketing exclusivity.
  • More on Amarin/Vascepa
Comments (7)
  • WilsonWagwa
    , contributor
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    At least the corrupt FDA is uniform in its treatment of Amarin. What else would you expect from the best agency money can buy?
    21 Feb, 08:45 PM Reply Like
  • Bob 88
    , contributor
    Comments (47) | Send Message
     
    I am a gambler and I am holding the Amarin stocks since after the FDA approval of Vascepa. This is a real and cruel torture . This is the first good news delivered by FDA for the last two years+. Amarin management still wants to evaluate whether to challenge the exclusivity term, 3 years granted verse 5 years expected. Do they learn how slow and inefficient FDA works? Good luck! I think any mediocre "good" news like this will not revive Amarin. Hopefully, this FDA exclusivity will add some value to the company for any potential buy-out (if any) in the unknown future.
    21 Feb, 09:10 PM Reply Like
  • SharkDude
    , contributor
    Comments (500) | Send Message
     
    Incredible. Stock would have been 20 bucks If this was done a year ago. Our government is the worst.
    21 Feb, 09:44 PM Reply Like
  • SharkDude
    , contributor
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    I stand corrected. What a slap in the face. Thanks FDA. Who do you work for? The people or GSK and Amgen? Easy answer. I bet they are really patting themselves on the back for this brilliant decision. I bet they worked real hard at it too.
    21 Feb, 09:53 PM Reply Like
  • WilsonWagwa
    , contributor
    Comments (50) | Send Message
     
    Like I said earlier. The way the corrupt FDA handled the entire process for AMRN was the best money could buy from big pharma (GSK etc etc} They were determined to bring AMRN down as to not let them get approval for major population group because of the success they generating million upon millions of dollars in that group.
    23 Feb, 08:15 AM Reply Like
  • cashewking
    , contributor
    Comments (210) | Send Message
     
    Just wondering has anyone ever successfully sued the FDA ?
    23 Feb, 08:43 AM Reply Like
  • silver6698
    , contributor
    Comments (4) | Send Message
     
    Corruption at its best.......
    23 Feb, 09:27 AM Reply Like
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