Replies to post #5469 on Amarin Corp Plc (AMRN)

[AtlasSnuggled]

the ever illustriuos BioBill has been linking
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=87392292

source
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202057Orig1s000MedR.pdf

Clinical Review Iffat Nasrin Chowdhury, MD NDA 202057 Vascepa/Icosapent Ethyl

4.4 ClinicalPharmacology
Omega-3 fatty acids (omega-3 FA), fats commonly found in marine and plant oils, are considered “essential” fatty acids, meaning that they cannot be synthesized by the human body but are vital for normal metabolism. 8 The three most commonly known omega-3 FA are eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), and alpha-linolenic acid (ALA).

The drug product from Amarin contains a purified icosapent ethyl. Icosapent ethyl (ethyl eicosapentaenoic acid or ethyl-EPA) is the ethyl ester of EPA. Icosapent ethyl acts as a prodrug for EPA, as it is hydrolyzed enzymatically by esterases, particularly pancreatic lipase, to liberate the free acid EPA.

so before you say " waita minute, its an ester, no fair"

http://www.gpo.gov/fdsys/pkg/CFR-2012-title21-vol5/pdf/CFR-2012-title21-vol5-sec314-108.pdf

Active moiety means the molecule or ion, excluding those appended portions of the molecule that cause the drug to be an ester,

[Biobillionair]

Tia, here's the prodrug link for Icosapent Ethyl: "The drug product from Amarin contains a purified icosapent ethyl. Icosapent ethyl (ethyl eicosapentaenoic acid or ethyl-EPA) is the ethyl ester of EPA. Icosapent ethyl acts as a prodrug for EPA, as it is hydrolyzed enzymatically by esterases, particularly pancreatic lipase, to liberate the free acid EPA."

Pg 20 of the FDA's Medical Review for the Marine approval. The review documents started getting posted on March 6.

I haven't found a prodrug that the FDA hasn't awarded 5 yrs of exclusivity to.

Williams