DUBLIN and MYSTIC, Conn., Aug. 17 Amarin Corporation plc (Nasdaq: AMRN), a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today announced that Colin W. Stewart has been appointed President, Chief Executive Officer (CEO) and a member of the Company's Board of Directors effective August 16, 2010. Mr. Stewart will be responsible for driving forward the Company's strategy to maximize the value of its lead product, AMR101, a new drug being studied in Phase 3 clinical trials for the treatment of high triglycerides. The Company announced last week that one of its Phase 3 trials, the MARINE trial, completed patient enrollment and randomization earlier than expected with top-line results now expected in early 2011.
Mr. Stewart has more than 30 years of experience in executive management and commercial positions for pharmaceutical companies, including five years as President and CEO of CollaGenex Pharmaceuticals, Inc. where he was responsible for the company's growth leading to its successful sale in 2008.
In addition, Mr. Stewart served ten years with the ASTA Medica Group, where he managed several business units in the United States and internationally. He began his career in sales and marketing for Winthrop Laboratories, Ltd. in the United Kingdom, and subsequently held a number of positions of increasing responsibility within the Sterling-Winthrop Group.
Dr. Declan Doogan, who has been serving as the Company's Interim CEO, will continue to support the Company as Chief Medical Officer providing Amarin access to the majority of his time.
Amarin's Chairman of the Board, Joseph Zakrzewski, commented, "We are very excited by the addition of Colin Stewart to the Amarin team. He brings a wealth of commercial and executive management experience, which complements the already strong technical and financial functions within the Company. Colin is expected to play a key role as we weigh our various alternatives for commercialization of AMR101." Mr. Zakrzewski went on to state that, "Declan Doogan deserves many thanks for his contributions as Interim CEO and we look forward to his continued contributions."
Mr. Stewart added, "I am very impressed by the progress Amarin has made since being restructured and recapitalized late last year. This progress is a tremendous credit to the whole team at Amarin with which I really look forward to working. With Phase 3 studies of AMR101 for two indications advancing well and scheduled to report in 2011, we will continue to explore every opportunity to maximize the potential commercial value of this promising drug, including potentially through one or more collaborations with larger pharmaceutical companies."
AMR101 is ultra pure ethyl icosapentate (ethyl-EPA). Significant scientific and clinical evidence supports the efficacy of ethyl-EPA in reducing triglyceride levels. Near the start of 2010, Amarin initiated two Phase 3 clinical trials to investigate the efficacy of AMR101 in reducing elevated triglyceride levels in two patient populations (the ANCHOR and MARINE trials). As separately reported, patient enrollment and randomization to dosing (2 grams, 4 grams and placebo) has been completed in the MARINE trial and is over half completed in the ANCHOR trial. Amarin expects to report preliminary top-line results from both trials in 2011 with results from the MARINE trial expected in the beginning of 2011.
Amarin Corporation plc is a clinical-stage biopharmaceutical company with expertise in lipid science focused on the treatment of cardiovascular disease. The Company's lead product candidate is AMR101 (ethyl icosapentate), which is presently being investigated in two Phase 3 clinical trials, one for the treatment of patients with very high triglyceride levels and the other for the treatment of patients with high triglycerides with mixed dyslipidemia on statin therapy. Both of these Phase 3 trials are conducted under Special Protocol Assessment (SPA) agreements with the U.S. Food and Drug Administration (FDA). Amarin also has next-generation lipid candidates under evaluation for preclinical development. For more information please visit www.amarincorp.com.
This press release contains forward-looking statements, including statements about the timing and success of clinical trial results, partnering and creation of shareholder value. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein are the following: anticipated operating losses and the likely need for additional capital to fund future operations; uncertainties associated generally with research and development, clinical trials and related regulatory approvals; the risk that historical clinical trial enrolment and randomization rates may not be predictive of future results; uncertainties relating to the timing of data collection and analysis for the ANCHOR and MARINE trials; dependence on third-party manufacturers, suppliers and collaborators; significant competition; loss of key personnel; and uncertainties associated with market acceptance and adequacy of reimbursement, technological change and government regulation. A further list and description of these risks, uncertainties and other matters can be found in Amarin's filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 20-F. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
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SOURCE Amarin Corporation plc