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Monday, June 24, 2013 9:44:07 AM
Vascepa is Icosapent Ethyl, the API
Icosapent Ethyl's active moiety is EPA
(http://www.fda.gov/ohrms/dockets/ac/99/slides/3506s2/tsld013.htm)
Draft Icosapent Ethyl guidance
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM347002.pdf
EPA metabolites produce the mechanisms of actions, reducing triglycerides, and reducing inflamation by increasing the concentrations of Resolivins (RvE1 & RvE2). This is the cellular level mechanism of actions of "fish oil" not under stood by Wall Street last week.
"Potential mechanisms of action include increased ß-oxidation; inhibition of acyl-CoA:1,2-diacylglycerol acyltransferase (DGAT); decreased lipogenesis in the liver; and increased plasma lipoprotein lipase activity."
From the Vascepa Label---http://www.vascepa.com/full-prescribing-information.pdf
In addition to beta-oxidation & inhibition of Acyl-CoA, EPA is metabolized by the cytochrome P 450 system. This is one of the natural pathways to Resolvins, and the cellular mechanism of action of systemic inflamation reduction.
EPA metabolism can be manipulated by drugs at multiple levels in the above mechanism to produce MASSIVE amounts of tissue specific Resolvins to treat Cancer, rheumatoid arthritis, Insulin resistance, obesity, CVD, Crohns Dz. on and on.... It's through these mechanism and manipulations that have GREATLY increased the value of EPA beyond the World statin sales number of $34 billion.
NCE and old generics can be combined with Vascepa (EPA) to target these systems. Aspirin, Tylenol, & Indometacin are available now to use off label. Vascepa 2 gms + Excedrine in the AM, Vascepa 2gms + 81 mg ASA in the PM... Has greatly reduced the pain in one Fibromyalgia patient in a weeks time.
The true value of this asset is only starting to be recognized and is likely the reason for the slow exclusivity decisions at the FDA level;)$$$
Williams
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