Revisiting Amarin Corp.

Amarin Corp. plc (AMRN) was trading around $10 when it was profiled on our site last August. The stock recorded a new 52-week high of $15.50 on Tuesday before closing the day's trading at $15.46. With the approaching FDA decision for AMR101, the company's investigational prescription omega-3 drug for the treatment of high triglycerides, the stock may be worth watching.

Triglyceride refers to a class of fat found in the bloodstream and its desirable level is less than 150 mg/dL. In the U.S. alone, about 40 million people are estimated to have triglyceride levels above 200 mg/dL.

There is one FDA-approved omega-3 fatty acid based drug - Lovaza developed by GlaxoSmithKline plc (GSK), for the treatment of patients with very high triglycerides at values greater than or equal to 500 mg/dl. Lovaza contains ethyl esters of omega-3 fatty acids (EPA and DHA) obtained from the oil of several fish sources.

Amarin submitted the New Drug Application for AMR101 to the FDA last September based on data from two phase III trials namely, MARINE and ANCHOR, seeking approval for the treatment of patients with very high triglycerides at values greater than or equal to 500mg/dL.

AMR101 is an ultra-pure omega-3 fatty acid in a capsule, comprising not less than 96% icosapent ethyl (ethyl-EPA).

According to Amarin, AMR101 is said to have significant advantages over Lovaza due to the fact that AMR101 neither has a fishy taste and smell nor does it elevate LDL-C, also known as 'bad cholesterol', levels like Lovaza. Increasing LDL-C levels is an unwanted effect of triglyceride lowering therapy.

The regulatory agency's decision date for AMR101 is set for July 26, 2012.

Once the AMR101 NDA is approved, the company plans to file a supplemental NDA for the use of AMR101 in treatment of patients with high triglyceride levels in the range of greater than or equal to 200 mg/dL to less than 500mg/dL who are on statin therapy for elevated LDL-cholesterol levels.

Seeking to protect the commercial potential of AMR101 to 2030 and beyond, Amarin is currently prosecuting over 25 pending U.S. patent applications. As recently as July 2, the United States Patent and Trademark Office issued a Notice of Allowance for the patent covering a stable pharmaceutical composition of AMR101 comprising at least 95% EPA that would have a patent term expiring no earlier than in 2030.

The company is also evaluating the efficacy of AMR101 in reducing major cardiovascular events in a high risk patient population on statin therapy in a trial dubbed REDUCE-IT outcomes study. Amarin expects to have the REDUCE-IT outcomes study substantially underway by the end of this year.

Being a clearly differentiated product for existing and new markets, Amarin sees a global blockbuster sales potential for AMR101.

If approved, AMR101 will have to compete with GlaxoSmithkline's Lovaza. In 2011, Lovaza logged $916 million in sales, all of which were generated in the U.S. and Puerto Rico.

Will Amarin's AMR101 clear the regulatory hurdle? Stay tuned!