Another month, another non-decision by the Food and Drug Administration about Amarin's (NASDAQ:AMRN) new chemical entity status for its lipid-lowering drug Vascepa.
The drug was approved in July, so the status would normally show up in the update in August, but investors have been checking every month -- on the Friday of the second full week of the month -- without an update.
The status hasn't been determined yet because Vascepa is basically a purified version of GlaxoSmithKline's (NYSE:GSK) fish oil Lovaza. There's some precedence for giving purified molecules NCE status, which entitles the holder to five years of exclusivity without generic competition; Sanofi's (NASDAQ:SNY) Lovenox, a low-molecular-weight heparin, was granted NCE status, even though other heparins were already on the market.
In past months, Amarin filed an SEC document letting investors know that it didn't think that the FDA would make a decision that month. But this month, it didn't even bother. Either the company didn't know, or this has dragged on so long that management has determined that the lack of news isn't material.
That's mostly been true from the beginning. The five years of exclusivity for NCE status runs concurrent with any patents, and Amarin has patents listed in the orange book that extend through 2030. If the patents hold up in court, the NCE exclusivity is essentially useless.
VIVUS (NASDAQ:VVUS), for instance, didn't get NCE status for Qsymia since the obesity drug is just a combination of two other drugs on the market. But no one seems to be stressing too much about Qsymia's "new combination" exclusivity, which only lasts three years, because it has patents through 2020.
There are many more important issues for investors to worry about. Whether Amarin can find a buyer/partner, whether it can expand its FDA approval to patients with less severe triglyceride levels, and whether the outcomes study can show that taking Vascepa lowers heart attacks, strokes, and such, are all much more important to Amarin's valuation than whether it gets NCE status.