Amarin Corporation plc (Nasdaq:AMRN) reported positive, statistically significant top-line results for both of its two pivotal Phase 3 clinical trials for AMR101 (icosapent ethyl), the MARINE trial (investigation of AMR101 as a treatment for patients with very high triglycerides [>=500 mg/dL]), as reported in November 2010, and the ANCHOR trial (investigation of AMR101 for the treatment of patients on statin therapy with high triglycerides [>=200 and =500mg/dL). The NDA for AMR101 is supported by data from both Phase 3 AMR101 clinical trials, MARINE and ANCHOR, in which trials AMR101 achieved all of the primary endpoints and was well tolerated with a safety profile comparable to placebo. The application will be subject to a standard review and will have a Prescription Drug User Fee Act (PDUFA) date of July 26, 2012. The PDUFA date is the goal date for the FDA to complete its review of the NDA.



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