Amarin Corp Plc (AMRN)

[HDGabor]

Pharmacydude & ziploc_1 & BB,

Vascepa (and not Marine or Anchor or R-IT) was entitled for NCE, it is always started by the date of the first approval (in this case July 26, 2012).

FDA refers to the new policy / interpretation of active moiety of naturally derived mixture (one-to-many instead of one-to-one). I could not find any policy or guidance which dealing with this and I think FDA has right regarding this, since EPA is definitely an active moiety in Lovaza, HOWEVER it’ not relevant for NCE determination, since moiety is “just” an interpretation of the statue by FDA. As Amarin said: “FDA has improperly substituted the words “active moiety” for the statute’s words (“active ingredient”).”

FDA was always consistent to decide NCE based on active moiety, however it was rejected by court several times as the statue (USC) is stronger, higher level than CFR.

I do not know when, but the final court ruling will grant the NCE status to Vascepa for the period 2012 – 2017 based on statue and previous decisions. (ie.: CONFUSION PERSISTS AROUND DRUG EXCLUSIVITY AND PATENT TERM EXTENSIONS FOR NEW CHEMICAL ENTITIES)

btw: I think that the new Fixed-Combination Guidance, is not relevant to Vascepa.