AMRN Exclusivity Decision Likely Delayed; Investors Should Look to Patents for Real Protection

Amarin (NASDAQ:AMRN) announced on Monday that it is unlikely Vascepa’s regulatory exclusivity will be listed in the August Orange Book supplement, due out in mid-September. After communications with the FDA last week, AMRN says the regulatory agency has yet to make a decision on Vascepa’s status as a New Chemical Entity, which would grant the drug longer market exclusivity – you can read about the implications in PropThink’s previous articles. While we view this delay as temporary, and significant progress on new long-term patents suggests that regulatory exclusivity is not a major issue – see PropThink’s previous report – some investors are still focused on the event, producing weakness in AMRN Tuesday. On the 4th, AMRN received what may be its most important patent, 12/702,889, and received three additional patents in the last week. Expect the stock to be off today, but investors should buy on the weakness, as the strong intellectual property around Vascepa means that the product is well protected. AMRN could even have a deal with a major drug company or potentially be acquired before year’s end.