Amarin Corp Plc (AMRN): Icosapent Ethyl has been scientifically...

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Biobillionair

Re: None

Tuesday, 04/30/2013 7:22:23 AM

Tuesday, April 30, 2013 7:22:23 AM

Icosapent Ethyl has been scientifically accepted as an EPA pro drug.
I don't have time to post all the links but they include the FDA, Physician's, and Pharm. D's.

Pro drugs have been controversial in being granted NCE status, yet in recent times all have succeed. (That I'm aware of)

Emend:
http://www.accessdata.fda.gov/drugsatfda_docs/NDA/2008/022023s000_AdminCorres_P2.pdf

Pro drug FDA:
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 aprodrug for EPA, as it is hydrolyzed enzymatically by esterases, particularly pancreaticlipase, to liberate the free acid EPA.

pg 20 in the medical review:
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202057Orig1s000MedR.pdf

This pro drug label has nothing to do with the approval of Anchor and is a new development for me. I'm back to NCE can happen at anytime before Anchor.

Williams