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Amarin Provides 2010 Year-End Review to Shareholders
Date:1/31/2011

d under a Special Protocol Assessment agreement (SPA) with the U.S. Food and Drug Administration (FDA). In contrast to previous studies of omega-3 fatty acids and fibrate treatments of patients with very high triglyceride levels, AMR101 is the first such triglyceride-lowering therapy demonstrated to reduce triglycerides without significantly increasing LDL-cholesterol levels. We expect to present the full data set at an upcoming medical conference this year.

Completed Patient Randomization for ANCHOR Trial Ahead of Schedule with Top-Line Results Expected in Q2 2011The ANCHOR trial, a multi-center, placebo-controlled, randomized, double-blind, 12-week pivotal study, evaluates the efficacy and safety of 2 grams and 4 grams of AMR101 in patients with high triglyceride levels (200 mg/dL to less than 500 mg/dL) who are also on statin therapy. Patients in this trial are characterized as having high triglyceride levels with mixed dyslipidemia (two or more lipid disorders) and are at high risk for the development of cardiovascular disease. Currently, no omega-3 based therapy is approved by the FDA for treating this patient population. The treatment of high triglyceride levels represents a major commercial opportunity as first-in-class prescription medicine, as an estimated 36 million patients in the U.S. alone have high triglycerides. The primary endpoint in this trial is triglyceride reduction from baseline compared to placebo. This trial is being conducted under an SPA agreement with the FDA.

Strengthened Amarin's Senior Management and Board of DirectorsA year ago, we were shifting our operational focus to our Research and Development Headquarters in the U.S., becoming solely focused on cardiovascular opportunities, and launching our Phase 3 trials.  The team as constituted for this mission completed the MARINE trial earlier than initially expected and we believe is poised to do the same with the ANCHOR trial. The team at Amarin, together with it
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SOURCE Amarin Corporation plc
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