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Amarin's Fat-lowering Drug Meets Goals In First Of Two Late-stage Trials

Monday before the bell, Amarin Corp. plc (AMRN) announced that its first late-stage clinical trial of lead drug candidate - the fat-lowering AMR101, met the primary endpoints with highly statistically significant reductions in triglycerides.

AMR101, an omega-3 fatty acid-based drug, is a semi-synthetic, ultra pure (>96%) ethyl ester of eicosapentaenoic acid (ethyl-EPA). AMR101 is studied under two phase III studies - MARINE and ANCHOR, under Special Protocol Assessment agreements with the FDA.

The MARINE trial, which enrolled 229 patients with fasting triglyceride levels greater than or equal to 500 mg/dl, is a 12-week pivotal study to evaluate the efficacy and safety of 2 grams and 4 grams of AMR101.

According to the company, the MARINE trial's primary endpoint, the percent change in TG (triglyceride) levels from baseline to week 12, was met for both the 4 gram and 2 gram dose groups. The patient group treated with 4 grams of AMR101 showed a significant median TG decrease of 33% compared to placebo, and the patient group treated with 2 grams of AMR101 showed a significant median TG decrease of 20% compared to placebo.

In a subgroup of patients with baseline TG of more than 750 mg/dl, the effect of AMR101 in reducing TG levels was even more significant. The median decrease in TG levels from placebo was 45% for 4 grams and 33% for 2 grams, both of statistical significance in the subgroup.

In the MARINE study, 25% of patients were on background statin therapy and they had much greater median reductions in TG, which were also statistically significant, than those not on statin therapy.

The common TG-lowering agents are known to elevate LDL cholesterol (bad cholesterol) levels by 40%-50% in patients with very high TG levels. However, AMR101 did not result in an increase in median LDL cholesterol compared to placebo at either dose, according to the company.

The ongoing ANCHOR study is a 650-patient, 12-week study to evaluate the efficacy and safety of 2 grams and 4 grams of AMR101 in patients with high triglyceride levels of 200-500 mg/dl who are on statin therapy (mixed dyslipidemia).

Based on the positive results of the MARINE trial, Amarin has preponed its plan of submitting a New Drug Application for AMR101 from 2012 to 2011.

The only one omega-3 fatty acid-based drug approved in the U.S. for treatment of patients with very high triglycerides (>500 mg/dl) is GlaxoSmithKline plc's (GSK) Lovaza. The same product is marketed in Europe as Omacor. In 2009, Lovaza logged in sales of £450 million ($702 million), up 31% over 2008. In the nine months ended September 30, 2010 Lovaza sales totaled $590 million.

According to Amarin, AMR101 is different from GlaxoSmithKline's Lovaza in that Lovaza contains ethyl esters of EPA and DHA while AMR101 contains ethyl ester of only EPA. DHA is known to elevate LDL cholesterol (bad cholesterol) levels. Therefore, AMR101, which is devoid of DHA, may not have the LDL effect. The daily dose of Lovaza is 4 grams (or 4 capsules) per day for patients with severe elevations of triglycerides of 500 mg/dl or above, while the daily dose of AMR101 is likely to be only half that of Lovaza.

Commenting on the results, Joseph Zakrzewski, Executive Chairman and CEO of Amarin, said, "The MARINE study was conducted in a population representative of millions of people with very high triglyceride levels, including more than 3.8 million in the U.S. alone. We believe that these results and the overall profile of AMR101 position the drug candidate to be best in class in this market.

AMRN closed Friday's trading at $3.55. In pre-market trading Monday the stock is up 19% to $4.23.

by RTT Staff Writer

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