Amarin Corp Plc (AMRN)

[Biobillionair]

Extremely significant and convinced me to send of two emails and CP comment.

Thanks Zum!

Ms. Behr and Senator Baldwin,

Amarin has publicly filed an update on its REDUCE-IT study. Based on the blinded data Amarin has estimated the scheduled 60% interim look will occur in 2016. The blinded data also affirms the CV event rate of 5.2%. Using this information it can be extrapolated the REDUCE-IT study will have 25% (look early 2016) to > 50% (look at mid-2016) reduction in cardiovascular events.

This leads to explaining to the Senate HELP Committee why the FDA’s delay in expanding the label for Vascepa, the related increased Health care costs assumed and lives lost. This is a Regulatory delay of 4 years, Amarin requested the Anchor data on the 7-26-2012 Marine approval.

(4 yrs) (All CV events in US population)(Vascepa’s Efficasy) = Cost to Americans that could have been saved

Thanks,

Jason R Williams

Amarin’s SEC 8K filing:
http://investor.amarincorp.com/secfiling.cfm?filingID=1193125-14-342253&CIK=897448


Vascepa CP comment 9-20-2014 1jy-8eh5-mviz
I respectfully request the Commissioner immediately grant Actions 1) Overturn CDER's decision to rescind Anchor SPA 4) PDUFA date was requested to be delayed 180 days or Wednesday, June 18, 2014.

I request the Commissioner Not DELAY these actions, until needed investigation can be concluded to answer other actions.

SPA was rescinded based on Fibrate CVOT outcomes studies. This assertation was incorrect based on several new studies and review of FIELD Fibrate sub-population.

Favorable effects of fenofibrate on lipids and cardiovascular disease in women with type 2 diabetes: results from the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study" Diabetologia 2014; DOI: 10.1007/s00125-014-3344-3.

Patients with type 2 diabetes are at increased risk of cardiovascular disease. Fibrate may help decrease the risk of cardiovascular disease in women and could be an option for patients who cannot tolerate statins.

This was a double-blind placebo-controlled study, which looked at 9,795 patients with diabetes, and was a secondary analysis where data were collected from the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study. 3,657 women and 6,138 men were given 200mg/day of fenofibrate or placebo for 5 years. Total cardiovascular events were assessed by sex.

According to data, fenofibrate improved triglyceride levels in both men and women by reducing LDL, non-HDL, and apolipoprotein B to a greater extent in women compared to men. Moreover, fibrate showed 30% reduction in overall cardiovascular outcomes in women (95% CI 8%-46%, P?=?0.008) compared to 13% reduction in men (95% CI -1%, 24%; P?=?0.07).

"Our results indicate that fenofibrate is generally safe for women with type 2 diabetes," authors wrote. "Although in the FIELD study, the primary endpoint of nonfatal (myocardial infarction) plus coronary death was not significantly reduced, the secondary endpoint of total cardiovascular events was reduced."

Overall, fibrates were cardioprotective in both men and women with type 2 diabetes. A reduction in cardiovascular disease risk in patients with low HDL cholesterol and high triglyceride levels was also seen, but there was more reduction in women compared to men. In conclusion, fenofibrate therapy should be considered for both sexes with type 2 diabetes.

Practice Pearls:
•Women with type 2 diabetes are at high risk for future cardiovascular disease.
•This study looks at long-term effect of fibrates on reducing cardiovascular effects in patients with type 2 diabetes
•Fenofibrate showed reduction in CVD risk in both men and women, but more significantly in women.
•Fibrates can be an option for patients who cannot tolerate statins.

Numerous new evidence has surfaced and clinical practice guidance’s changed since the October 16 th Ad Com. Based on the efficacious results of Vascepa in this same Field subset population it is reasonable to presume Vascepa will have like results reducing CVE. Taking into the consideration of Vascepa's safety profile, it's reasonable to grant full approval sNDA 005 with a clear label warning Vascepa has yet to prove it reduces cardiac events, but the trial is currently ongoing.

It's not within the FDA mission to create practice guidelines, or approve of drugs based on selected practice guidelines when clinical opinion varies.

Respectfully,

Williams