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Saturday, June 22, 2013 7:13:29 PM
"Studies suggest that EPA reduces hepatic very low-density lipoprotein triglycerides (VLDL-TG) synthesis and/or secretion and enhances TG clearance from circulating VLDL particles. 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
DGAT-1 inhibitors have potential for the treatment of obesity[6][7] and a number of DGAT-1 inhibitors are in clinical trials for this indication.[8]
http://en.wikipedia.org/wiki/Diglyceride_acyltransferase
Possible pediatric indication for prevention of obesity with at risk children? Also prevention of type 2 DM, DGAT mechanism and insulin resistance. p450 metabolism of EPA producing RvE1 & RvE2
http://jimmunol.org/cgi/content/meeting_abstract/190/1_MeetingAbstracts/130.13
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I have a TON of circumstantial evidence that the FDA is intentially delaying Amarin's process due to the anti inflammatory metabolites of EPA. The money flows through C-Path, a non profit organization financed by donations and grants from the FDA. It was "think tanked" on the Vioxx disaster. Dr. Janet Woodcock, CDER director, happens to be on the board of directors. Critical Path institute or C-Path used my tax dollars in the form of grants to pay 52 employees $6,661,380 in salarys for 2012.
The real interesting players: Dr. Alastair Wood, he's a partner in Symphony Capital, "a leader in bio pharmaceutical structured investing". On top of his board of director job at C-Path he's busy with chairing Ad Com committees, FDA non-prescription and COX-2 inhibitors. Vioxx, is his great success story, as under his leadership the FDA saw fit to allow Merck to continue to sell their product. Including a vote from Amarin's friendly cardiologist Dr. Steven Nissen. For those that don't know much about Vioxx, the FDA approved it and kept it on the market, giving people two times the MI risks as OTC COX-2 drugs. At least the mind set for C-Path was cemented and Dr. Woodcock and Dr. Wood could get whatever stupid Azz politicians approval for C-Path.
Another notable VIP board member with Dr. Woodcock is Peter B. Corr, he happens to be the Chairman of the Board for Auven Therapeutics. Auven leading drug candidate Kiactar was "lucky" enough to get orphan status. I'm sure it's just chance that the mechanism of action blocks AA and GAG interaction. That might sound familiar if you've heard of an AA:EPA ratio. Auven Thearpeutics also happens be a major partner in Resolvyx, their lead drug candidate is RvE1, Resolvin.....
It also great to know all of the above is supported by the NIH, they happen to hold the most solid patents on Resolivins. Resolvins, for a refresher...is the last active metabolite produced for EPA & DHA.
You'd think that was enough, right! ShaAuhree Buckman is also on the Board of C-Path, she's the boss at CDER biostatistics....
http://c-path.org/
http://www.symphonycapital.com/
http://c-path.org/project-pipeline.cfm
The active metabolites of Amarin's Vascepa, cut's many pipeline drugs out of the loop. The "FDA" is just talking to their friends first before they make a decision. You tax payers and investors will just have to wait for the politician to get rich first.
Just my opinion
Williams
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