Amarin Corp Plc (AMRN)

[HDGabor]

Thx, but I am still interested in JL's view (I am not 100% sure, it's just my view.

One addition, Amarin CC transcript:

In the October 2013, Vascepa advisory committee meeting, FDA stated that to approve an indication based upon triglyceride lowering in statin treated patients with triglyceride levels below 500 mgs per deciliter, it needs to be confident that triglyceride lowering will result in cardiovascular risk reduction.
As previously disclosed, failed results of the cardiovascular outcome studies of other drugs, fenofibrates and the ACCORD-Lipid study and nicotinic acid in the AIM-HIGH and HPS2-THRIVE studies, reduced FDA's confidence in the use of triglycerides alone as a surrogate for regulatory approval of a drug focused on cardiovascular risk reduction in this population, such that the FDA would like to see outcomes data to confirm cardiovascular reduction benefit.
This is a regulatory policy focused issue for the FDA. The FDA has considered against the backdrop of HDL rising drugs that fail to show cardiovascular benefit.
In our communications with FDA, it is clear that in the backdrop of these HDL studies, FDA has revaluated the situation and has adopted a more conservative approach than previous applied for biomarker based approvals targeted towards cardiovascular risk reduction. FDA expressed to us that the accumulation of the scientific information that led FDA to conclude that HDL cholesterol could not be used as a surrogate end point for cardiovascular risk reduction occurred in the same timeframe as its decision to rescind the ANCHOR SPA agreement.
FDA noted to us that this illustrates that the science related to the use of drug induced changes in lipid parameters as surrogates for cardiovascular risk reduction remains unstable and fluid. FDA noted an exception for LDL cholesterol for which there have been successful outcome studies. So, they went onto mention that even for LDL cholesterol, there may be new answers which come out of future studies.

For Amarin, reduce it or answer a less regulatory legal and more patient focused questions that goes well beyond the validity of triglyceride as a surrogate, specifically, whether the cumulative effects of Vascepa will result in cardiovascular risk reduction in the high risk patient studied. The effects of Vascepa including improvement in triglyceride level and other lipid lipoprotein and inflammatory biomarkers that were demonstrated in the ANCHOR trial, as well as potentially other effects not yet fully studied, but explored and described in the scientific literature. The safety profile of Vascepa that was established in the completed Phase 3 studies is comparable to placebo and compares favorably to existing drug therapies for use as [indiscernible] to statin therapy in treating this at-risk patient population.
Although for regulatory approval purposes, FDA's confidence in the use of triglycerides is a cardiovascular risk to surrogate was lowered by the cited studies of different class drugs. FDA could not and specifically did not rule out that triglyceride lowering effects of Vascepa could result in cardiovascular risk reduction in the ongoing REDUCE-IT study. We discussed with FDA that REDUCE-IT's future success might also be attributable to other favorable effects of Vascepa and its unique single active ingredient, EPA.
The ANCHOR SPA agreement remains rescinded. There has been no determination on the ANCHOR sNDA. We tried to engage FDA on the ANCHOR sNDA with every available opportunity over the last 10 months and offered a number of compromises. But FDA maintained the SPA appeal and sNDA are two separate matters and did not address the ANCHOR sNDA in our communication on the ANCHOR SPA appeal.

Amarin continues to believe that approval of an indication based upon the ANCHOR clinical trial results is in the best interest to patient care. As a reminder, Vascepa achieve all primary and secondary endpoints in the pivotal ANCHOR Phase 3 study. As previously disclosed, prior to completion of a successful outcome study, we see FDA approval of an ANCHOR indication and approval of ANCHOR data in the label as an uphill battle.
As to steps forward, aside from stating that we're again reaching out to FDA for resolution on the sNDA, we will not detail our plans on this call. We have continued to consult with our nationally recognized regulatory clinical and legal advisors who share our passion for approval of the ANCHOR indication.

Maybe also the new question put to the AdCom advisors

Agree, but It's done I wrote earlier that well before (or instead of) the Oct 16 public "ANCHOR" AdCom meeting, FDA had to address this question to an AdCom, to special government employees, or to other consultants.