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Amarin is a clinical-stage biopharmaceutical company focused on developing improved treatments for cardiovascular disease. The Company is currently focusing its efforts on AMR101, a prescription-grade omega-3 fatty acid, comprising not less than 96% ultra pure icosapent ethyl (ethyl-EPA).

Cardiovascular Programs

Amarin has completed two pivotal Phase 3 studies of AMR101 under Special Protocol Assessment Agreements (SPA) with the U.S. Food and Drug Administration (FDA), MARINE and ANCHOR.

The MARINE study: A multi-center, placebo-controlled, randomized, double-blind, 12-week pivotal study to evaluate the efficacy and safety of 2 grams and 4 grams of AMR101 in 229 patients with fasting triglyceride levels of ≥500 mg/dL. Patients with this level of triglycerides are characterized as having very high triglyceride levels as outlined in the National Cholesterol Education Program (NCEP) Expert Panel (Adult Treatment Panel III, 2002), or the NCEP Guidelines. The primary endpoint in the trial was the percentage change in triglyceride level from baseline compared to placebo after 12 weeks of treatment. Amarin reported top-line results of this trial in November 2010 demonstrating that AMR101 effectively lowered triglyceride levels in patients with very high triglycerides (≥500 mg/dL) without significantly increasing low-density lipoprotein cholesterol (LDL-C). The MARINE trial results also included favorable findings with respect to significant reductions in total cholesterol, non-HDL-C, Apo B (Apolipoprotein B), and Lp-PLA2 levels, together with a safety profile for AMR101 comparable to placebo. The trial's primary endpoint, the percent change in triglyceride levels from baseline to week 12 compared to placebo, was met for both the 4 gram and 2 gram dose groups. The MARINE trial was required to meet a stringent level of statistical significance of 1% (p < 0.01), as agreed in our SPA with the FDA.

Amarin submitted a New Drug Application (NDA) to the FDA in September 2011 requesting approval to market and sell AMR101 for the indication being studied in the MARINE trial in the United States. The submission is based on the entire data set from the Company's AMR101 development program, including safety and efficacy data from the Phase 3 MARINE and ANCHOR studies.

The ANCHOR trial: A multi-center, placebo-controlled, randomized, double-blind, 12-week pivotal Phase 3 study to evaluate the efficacy and safety of 2 grams and 4 grams of AMR101 in 702 patients with high triglycerides (≥200 and <500mg/dL) who are on statin therapy. Patients in this trial are characterized as having high triglyceride levels, as outlined in the clinical guidelines established by the National Cholesterol Education Program Adult Treatment Panel III (NCEP III), with mixed dyslipidemia (two or more lipid disorders). The primary endpoint in the trial is the percentage change in triglyceride level from baseline compared to placebo after 12 weeks of treatment. The secondary endpoint was LDL-C non-inferiority. In April 2011, the Company reported positive, statistically significant top-line results for the trial's primary endpoint and announced that it also achieved the LDL-C non-inferiority criterion. No prescription omega-3 based drug is currently approved in the United States for treating high triglyceride levels in statin-treated patients who have mixed dyslipidemia.

Amarin plans to submit a Supplemental NDA (sNDA) seeking approval for the indication studied in the ANCHOR trial once the REDUCE-IT cardiovascular outcomes study is substantially underway.

The REDUCE-IT (Reduction of Cardiovascular Events with EPA - Intervention Trial) Outcomes trial: In REDUCE-IT, for which the Company has received a SPA agreement with the FDA in August 2011, Amarin will evaluate the effectiveness of AMR101 in reducing the first major cardiovascular events in an at-risk patient population. The control arm of the study will be patients on optimized statin therapy. The active arm of the study will be patients on optimized statin therapy plus AMR101. All subjects enrolled in the study will have elevated triglyceride levels and either coronary heart disease or risk factors for coronary heart disease. Amarin estimates that the study will require approximately 8,000 patients and take approximately 6 years for completion. The company expects to commence clinical site enrollment for REDUCE-IT prior to the end of 2011.

This page last updated on October 13, 2011.