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Approval of the ANCHOR sNDA Would Expand Use of Vascepa to Include the Treatment of Patients with High Triglycerides (≥200 mg/dL and <500 mg/dL) with Mixed Dyslipidemia
BEDMINSTER, N.J., and DUBLIN, Ireland, Oct. 9, 2013 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, today announced details for its planned conference call to discuss the results of the U.S. Food and Drug Administration (FDA) advisory committee meeting in connection with the FDA's review of the supplemental New Drug Application (sNDA) seeking approval for the use of Vascepa® (icosapent ethyl) capsules in the proposed ANCHOR indication, as an adjunct to diet in the treatment of adult patients with high triglycerides (TG ≥200 mg/dL and <500 mg/dL) with mixed dyslipidemia. Members of Amarin senior management will host this event on Wednesday, October 16, 2013, at 7:00 p.m. ET, following the conclusion of the ANCHOR advisory committee meeting scheduled for earlier that day.
To participate in the call, please dial 877-407-8033 within the United States or 201-689-8033 from outside the United States. A replay of the call will be made available for a period of two weeks following the conference call. To hear a replay of the call, dial 877-660-6853 (inside the United States) or 201-612-7415 (outside the United States). A replay of the call will also be available through the company's website shortly after the call. For both dial-in numbers please use conference ID 100205. The conference call can also be heard live via the investor relations section of the company's website at
Amarin Corporation plc is a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health. Amarin's product development program leverages its extensive experience in lipid science and the potential therapeutic benefits of polyunsaturated fatty acids. Vascepa
® (icosapent ethyl), Amarin's first FDA approved product, is a patented, ultra pure omega-3 fatty acid product comprising not less than 96% EPA. For more information about Vascepa visit
www.vascepa.com. For more information about Amarin visit
About FDA advisory committee meetings
Advisory committees provide FDA with independent advice from outside experts on issues related to human and veterinary drugs, vaccines and other biological products, medical devices, and food. In general, advisory committees include a chair, multiple members, plus a consumer, industry, and sometimes a patient representative. Additional experts with special knowledge may be added for individual committee meetings as needed. Recommendations from the advisory committee will be considered by the FDA in its review, but the FDA is not bound to follow them in determining whether to approve an application.