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FDA Meeting to Discuss Development Plan Completed Successfully
DUBLIN, Ireland | July 22, 2008 | Amarin Corporation plc (NASDAQ: AMRN) today announced that the Company recently met with officials at the U.S. Food and Drug Administration (FDA) to discuss the Company’s plans to develop AMR101 for the treatment of hypertriglyceridemia. Following these discussions, the Company is proceeding to Phase 3 with AMR101 in hypertriglyceridemia.
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 path forward for the program. We are particularly pleased that we can proceed to Phase 3”.
Thomas Lynch, Chairman and Chief Executive Officer of Amarin, added “Over the past year we have assembled a highly experienced team of cardiovascular experts to develop AMR101 for this significant indication. Our initial objective of designing the Phase 3 program and obtaining FDA feedback has been achieved. Having completed our recent financing, we now look forward to 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 has previously investigated AMR101 in central nervous system (CNS) disorders in several double-blind, placebo controlled studies, including Phase 3 trials in Huntington’s disease. Over 900 patients have received AMR101 in these studies, with over 100 receiving continuous treatment for a year or more. In all studies performed to date, AMR101 has shown a very good safety profile.
Hypertriglyceridemia refers to a condition in which patients have high blood levels of triglycerides and is associated with increased levels of heart disease. It is one component of a range of lipid disorders collectively referred 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 those diagnosed with hypertriglyceridemia.
Numerous studies have demonstrated the safety, tolerability and efficacy of Ethyl-EPA in lowering plasma triglycerides in patients with high triglyceride levels of varying degrees of severity. In Japan, an Ethyl-EPA prescription product has been approved for the treatment of high triglycerides and has been on the market for seventeen years. Data from Amarin’s Huntington’s disease trials indicate that AMR101 lowers triglycerides in patients with elevated baseline levels.
About Amarin
Amarin is a biopharmaceutical company focused on improving the lives of patients suffering from cardiovascular and central nervous system (CNS) diseases. Amarin’s cardiovascular programs, including AMR101 for hypertriglyceridemia, capitalize on the known therapeutic benefits of essential fatty acids in cardiovascular disease. Amarin’s CNS development pipeline includes programs in myasthenia gravis, Huntington’s disease, Parkinson’s disease, epilepsy and memory. Amarin is listed in the U.S. on the NASDAQ Capital Market (“AMRN”).
SOURCE: Amarin |
