Another Case Made for Amarin's (AMRN) Vascepa Missing NCE Status
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Amarin (Nasdaq: AMRN) is active in trading today, amid more market chatter over its NCE status.
One important point was brought up about the FDA decision by a biotech watcher: active moiety. The FDA considers this in its decision whether to grant NCE or not, which gives a formulation five-year exclusivity.
For Amarin's Vascepa, its active moiety is EPA, which is also found in Glaxo's (NYSE: GSK) Lovaza. Th FDA already granted Lovaza NCE status, making it unlikely that Amarin would have anything but a fight on its hands with the FDA to get Vascepa pushed through. Hence the delay in the FDA's decision, as Amarin continues to battle and appeal an FDA decision that is negative. The FDA can, after all, make an exception to the rule if a worthwhile cause is argued, but may come with some restrictions.
In terms of patents, those don't mean much and won't block competition from launching "one off" products, as cited earlier this week.
Shares of Amarin are down modestly Friday, having started off positive and plunging lower at the start. Third-quarter results from the pharma are expected out next Thursday after markets close, with the Street seeing a loss of 22 cents per share and no revs.
One important point was brought up about the FDA decision by a biotech watcher: active moiety. The FDA considers this in its decision whether to grant NCE or not, which gives a formulation five-year exclusivity.
For Amarin's Vascepa, its active moiety is EPA, which is also found in Glaxo's (NYSE: GSK) Lovaza. Th FDA already granted Lovaza NCE status, making it unlikely that Amarin would have anything but a fight on its hands with the FDA to get Vascepa pushed through. Hence the delay in the FDA's decision, as Amarin continues to battle and appeal an FDA decision that is negative. The FDA can, after all, make an exception to the rule if a worthwhile cause is argued, but may come with some restrictions.
In terms of patents, those don't mean much and won't block competition from launching "one off" products, as cited earlier this week.
Shares of Amarin are down modestly Friday, having started off positive and plunging lower at the start. Third-quarter results from the pharma are expected out next Thursday after markets close, with the Street seeing a loss of 22 cents per share and no revs.
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