Amarin Corp PLC, formerly known as Ethical Holdings plc was incorporated under the laws of England and Wales on March 1, 1989 under the Companies Act 1985. It is a biopharmaceutical company with expertise in lipid science focused on the commercialization and development of therapeutics to improve cardiovascular health. The Company's product Vascepa (icosapent ethyl) capsules is approved by the U.S. Food and Drug Administration for the use as an adjunct to diet to reduce triglyceride levels in adult patients with severe (TG>500mg/dL) hypertriglyceridemia. On January 28, 2013 the Company commenced full commercial launch of Vascepa. The Company refers to its second indication for Vascepa as the ANCHOR indication. The FDA views the proposed ANCHOR indication as ostensibly and impliedly an indication to reduce cardiovascular risk. In addition, in December 2011, the Company announced commencement of patient dosing in cardiovascular outcomes study of Vascepa, titled REDUCE-IT or Reduction of Cardiovascular Events with EPA-Intervention Trial. The REDUCE-IT study is designed to evaluate the efficacy of Vascepa in reducing cardiovascular events in a high risk patient population on statin therapy. On January 28, 2013, the Company commenced full commercial launch of Vascepa in the United States for use in the MARINE indication. The Company now markets Vascepa in the United States through sales force of approximately 150 sales professionals and also employed marketing and medical affairs personnel to support commercialization of Vascepa. As of February 1, 2014, over 16,000 clinicians had written prescriptions for Vascepa. In November 2010, the Company reported top-line data for the MARINE trial. Vascepa was well tolerated in the MARINE trial, with a safety profile comparable to placebo and there were no treatment-related serious adverse events observed. The Company uses third party manufacturers and suppliers to manufacture clinical and commercial quantities of ethyl-EPA, which constitutes the only active pharmaceutical ingredient within Vascepa, to encapsulate, bottle and package Vascepa and to maintain inventory of Vascepa. The Company currently relies on Patheon for the encapsulation of Vascepa. The Companies competitors include GlaxoSmithKline plc and AbbVie, Inc., and Niaspan. The Company is subject to regulation by government authorities, including FDA.
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