BEDMINSTER, NJ ( TheStreet) --The U.S. Food and Drug Administration approved Amarin's (AMRN - Get Report) Vascepa on July 26 yet almost two months later, regulators still can't decide if the prescription fish-oil pill deserves five years of market exclusivity as a New Chemical Entity (NCE).
The latest "non decision" on Vascepa's NCE status was disclosed Monday night in an Amarin regulatory filing.
Amarin has a serious problem here, folks.
My read of the tea leaves: FDA decided long ago that Vascepa's chemical structure -- its "active moiety" -- is too similar to GlaxoSmithKline's (GSK - Get Report) Lovaza. Therefore, Vascepa can't be granted NCE status and the much-coveted five years of market exclusivity that goes along with the designation. The FDA's consolation prize is three years of exclusivity for Vascepa, but that also means Amarin will likely face almost immediate generic challenges to the drug's patents.If FDA has made up its mind internally to deny NCE status to Vascepa, why not just come out with the news already? Because Amarin appears to be doing all it can to stave off the bad news, including deploying a small army of lawyers to lobby, cajole and strong-arm FDA to reverse its decision. Remember the June meeting between Amarin and FDA? That's the only logical explanation for this ridiculous delay. Amarin bulls counter with two arguments: 1) NCE status is irrelevant because Amarin's recent Vascepa patents wins are more important; or 2) the recent Vascepa patent wins will persuade FDA to grant the drug NCE status. If NCE status isn't important, why is everyone so keenly focused on it? And why are Amarin shares still trading at a discount to where the stock stood on the day of Vascepa's approval? Moreover, granted patents have no role in the FDA's NCE decision-making process, which is described in the agency's regulations, says John Tucker, an analyst at BioMedTracker. Tucker, a chemist by training, believes Vascepa doesn't deserve NCE status. Nor does Dr. Andrew Goodwin of Chimera Research Group. His argument against can be found here. I used to doubt these guys, but no longer. I think they're right.