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Dr. Declan Doogan, Head of Research and Development of Amarin, commented:"The meeting with the FDA was very successful as it gives us a clear pathforward for the program. We are particularly pleased that we can proceed toPhase 3."
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Thomas Lynch, Chairman and Chief Executive Officer of Amarin, added:"Over the past year we have assembled a highly experienced team ofcardiovascular experts to develop AMR101 for this significant indication. Ourinitial objective of designing the Phase 3 program and obtaining FDA feedbackhas been achieved. Having completed our recent financing, we now look forwardto conducting the Phase 3 program."
AMR101 is an ultra-pure ethyl ester of eicosapentaenoic acid (Ethyl-EPA).Amarin has collected a substantial body of data on AMR101 to date. Amarin haspreviously investigated AMR101 in central nervous system (CNS) disorders inseveral double-blind, placebo controlled studies, including Phase 3 trials inHuntington's disease. Over 900 patients have received AMR101 in thesestudies, with over 100 receiving continuous treatment for a year or more. Inall studies performed to date, AMR101 has shown a very good safety profile.
Hypertriglyceridemia refers to a condition in which patients have highblood levels of triglycerides and is associated with increased levels ofheart disease. It is one component of a range of lipid disorders collectivelyreferred to as dyslipidemia. The overall dyslipidemia population in the U.S.is believed to be in excess of 100 million, with over 10 million of thosediagnosed with hypertriglyceridemia.
Numerous studies have demonstrated the safety, tolerability and efficacyof Ethyl-EPA in lowering plasma triglycerides in patients with hightriglyceride levels of varying degrees of severity. In Japan, an Ethyl-EPAprescription product has been approved for the treatment of hightriglycerides and has been on the market for seventeen years. Data fromAmarin's Huntington's disease trials indicate that AMR101 lowerstriglycerides in patients with elevated baseline levels.
About Amarin
Amarin is a biopharmaceutical company focused on improving the lives ofpatients suffering from cardiovascular and central nervous system (CNS)diseases. Amarin's cardiovascular programs, including AMR101 forhypertriglyceridemia, capitalize on the known therapeutic benefits ofessential fatty acids in cardiovascular disease. Amarin's CNS developmentpipeline includes programs in myasthenia gravis, Huntington's disease,Parkinson's disease, epilepsy and memory. Amarin is listed in the U.S. on theNASDAQ Capital Market ("AMRN").
Disclosure Notice
The information contained in this document is as of July 22, 2008. Amarinassumes no obligation to update any forward-looking statements contained inthis document as a result of new information or future events ordevelopments. This document contains forward-looking statements aboutAmarin's financial condition, results of operations, business prospects andproducts in research that involve substantial risks and uncertainties. Youcan identify these statements by the fact that they use words such as "will","anticipate", "estimate", "expect", "project", "forecast", "intend", "plan","believe" and other words and terms of similar meaning in connection with anydiscussion of future operating or financial performance or events. Among thefactors that could cause actual results to differ materially from thosedescribed or projected herein are the following: Amarin's ability to maintainsufficient cash and other li
