Amarin prevails in law suit against FDA on Vascepa NCE exclusivity

Judge Randolph Moss of the federal district court for the District of Columbia has granted US biotech firm Amarin’s (Nasdaq: AMRN) motion for summary judgment in the company's law suit against the US Food and Drug Administration seeking an order requiring FDA to recognize five-year, New Chemical Entity (NCE), marketing exclusivity for Vascepa(icosapent ethyl) capsules.

Amarin's shares rose as much as 44% to $2.80 on the Nasdaq on the news, but later drifted back to $2.16.

It is an interesting and probably precedent-setting ruling, comments Kanak Kanti De, in a posting of Seeking Alpha. The law suit was a mess created by the FDA itself, when it tried to interpret a previous legislation in a proprietary manner. The matter concerned the definition of "active moiety" and how the five-year exclusivity (in practice, probably a little longer) shall follow. This is critical for a company because with the exclusivity from its NCE, it can virtually prevent competition for a few more years, he added.