Amarin Corp Plc (AMRN)

[Biobillionair]

After a little DD it appears the argument can be made for ATM (active ingrediate in Atorvastatin) as qualifying for NCE. Atorvastatin is a prodrug of ATM. A mixture of EPA and ATM appears to be most effective lower agent of lipids and LDL. More so than EPA/CRESTOR. The basis of the argument rest with the success of Emends NCE status.
http://www.accessdata.fda.gov/drugsatfda_docs/NDA/2008/022023s000_AdminCorres_P2.pdf

There's a number of studies about ATM, it wasn't sought after as a single agent due to the superior results of the prodrug Atorvastatin. However when combined with EPA (Vascepa), the combo turns into the most potent cholesterol/lipid agent ever.

Amarin's 994 patent application I suspect will win out on the non obviousness of the combo potency, while Pfizer R&D struggles to figure out who to fire.

A 505b2 application could be filed after approval of '994 requesting 5 yrs NCE, data for ATM can be used from a zillion different studies. The increase in potency is probable due to the synergistic antioxidant mechanism with the Icosapent ethyl.
http://www.ncbi.nlm.nih.gov/pubmed/16464853

This raises the bar significantly in a BO, and is perhaps the greatest Amarin patent thus far.

Sleep tight shorty.