October 10, 2012
Amarin (Nasdaq: AMRN ) generated a lot of investor excitement this summer when its hypertriglyceridemia drug Vascepa was approved by the FDA. Its main competitor in this therapeutic area is GlaxoSmithKline's (NYSE: GSK ) Lovaza.
While the stock is up significantly year to date, its share price took a hit today on news that the FDA still hasn't decided whether Vascepa qualifies as a New Chemical Entity, or NCE. Drugs that gain NCE status enjoy five years of exclusivity on the market, while those that don't only get three years. Nevertheless, in both cases Amarin will have to rely on its intellectual property to shield Vascepa from generic competition beyond these time frames.
In the following video, health care analysts Max Macaluso and David Williamson expand on these points and discuss Amarin's drop today.
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