Amarin Corp Plc (AMRN)

[Biobillionair]

Patel
CP was hand deliverered Feb 6 2013, two weeks to the date MAPP 5021.1 was posted.

The CP requested a change in the OB for Lovaza after the FDA spent 6 months defining the differences between Lovaza and Vascepa, including two RLD's.

MAPP 5021.1 Naming of Drug Products Containing Salt Substances:
PURPOSE
"This MAPP describes how CDER will apply the United States Pharmacopeia (USP)
Monograph Naming Policy for Salt Drug Substances in Drug Products and Compounded Preparations1 (the USP Salt Policy2) to prescription drug products3 to ensure consistent drug product naming when the USP Salt Policy becomes official on May 1, 2013. This MAPP also provides information to help reviewers determine when the USP Salt Policy’s exceptions should be granted."

MAPP 5021.1 has to do with naming the active moiety, the CP requested Lovaza's Active Moiety change from mix of ethyl esters to 900 mg of EPA x mg and DHA x mg.

It's my assertation a former Attorney ,for the FDA, filed a CP with inside knowlege of 5021.2 to further delay the exclusivity of Vascepa. It's well known CP have been used before to manipulate exclusivity and generic entries.
The client of Crowell & Moring has some explaining to do and so does the FDA.

This BS exclusivity delay changed Amarin's whole game plan.