Amarin Announces New Clinical Data Showing Significant Reductions in Apolipoprotein C-III Levels in MARINE and ANCHOR Studies of Vascepa(R)
April 08, 2013
BEDMINSTER, N.J., and DUBLIN, Ireland, April 8, 2013 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today additional data from Amarin's previously announced MARINE and ANCHOR Phase 3 clinical trial results of Vascepa® (icosapent ethyl) related to the effect of Vascepa on apolipoprotein C-III (Apo C-III). The lipoprotein Apo C-III is thought to inhibit the clearance of triglycerides from the blood. People who do not produce Apo C-III have lower levels of triglycerides and lower instances of cardiovascular disease.
In Amarin's MARINE and ANCHOR trials, the 4 gram dose of Vascepa achieved reductions in Apo C-III levels of 25.1% (p < 0.0001) and 19.2% (p < 0.0001) compared to placebo, respectively. Amarin previously announced the efficacy and safety results of its MARINE and ANCHOR trials, including achievement of the primary endpoints of these studies with respect to triglyceride reduction as well as the positive effect of Vascepa with respect to levels of apolipoprotein B (Apo B), non-high-density lipoprotein (non-HDL-C), total cholesterol (TC), and very low density lipoprotein cholesterol (VLDL-C). The data on Apo C-III were collected from post-hoc analyses of the MARINE and ANCHOR trials. Amarin plans to present additional data related to Vascepa's effect on Apo C-III at an upcoming scientific meeting.
"Amarin is proud of the robust performance of Vascepa in the MARINE and ANCHOR studies," stated Steven B. Ketchum, Ph.D., President of Research and Development of Amarin. "The Apo C-III data announced today are another example of these positive results." About Amarin
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 www.amarincorp.com. The Amarin Corporation plc logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=13817
Forward-looking statements This press release contains forward-looking statements, including statements about the potential efficacy, safety and therapeutic benefits of Amarin's product candidates, Amarin's clinical trial results, and the expected timing of future publication, including statements about the clinical importance of certain biomarkers and the impact of Vascepa on such biomarkers. 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 include uncertainties associated generally with research and development, clinical trials and related regulatory approvals, including the risk that historical clinical trial results may not be predictive of future results in replicated in larger patient populations. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin's filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-K. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Amarin 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.Nothing in this press release should be construed as marketing the use of Vascepa in any indication that has not been approved by the FDA.
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