Amarin Corp Plc (AMRN)

[Biobillionair]

Ty
Dr. Goldenberg's thoughts:
"The active moiety in GlaxoSmithKline’s Lovaza, a similar agent for the treatment of hypertriglyceridemia, is a mixture of omega-3-acid ethyl esters that includes icosapent ethyl (EPA), docosahexaenoic acid (DHA), and a few others. Without requiring GlaxoSmithKline to specify which ester helps to lower triglycerides, the FDA considered the mixture of EPA and DHA as the active moiety that is responsible for the physiological and pharmacological action of Lovaza. Vascepa might have an advantage over Lovaza; it does not increase LDL-C levels, which has sometimes been observed with Lovaza.

The FDA considers Vascepa to be a new chemical entity. It contains only EPA but not DHA, and it does not contain any appended portions of both EPA and DHA that cause them to be an ester, salt, or other non-covalent derivative. Therefore, its active moiety has not been previously approved by the FDA in any other application submitted under Section 505(b) of the Federal Food, Drug, and Cosmetic Act."
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First, the FDA considers Lovaza to be a mixture of Omega 3 Ethyl Esters, NO Icosapent Ethyl. Lovaza contains "eicosapentaenoic acid ethyl ester (EPAee)".
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM320011.pdf

Second, the FDA considers Icosapent Ethyl to be a prodrug of EPA, Type one prodrug activated by the GI system. "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 Vascepa's Medical review.
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202057Orig1s000MedR.pdf

In my opinion he was right about the mixture, wrong about the Icosapent Ethyl in Lovaza. He new nothing of the Prodrug nor did he have access to the two generic formulations for both Vascepa and Lovaza. I'm sure he would agree today that Icosapent Ethyl is a prodrug of EPA, and thus a NCE completely differentiated from anything in Lovaza.

Williams