BEDMINSTER, N.J., and DUBLIN, Ireland, May 2, 2014 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today the presentation at the National Lipid Association Annual Scientific Sessions, of new post-hoc analyses of the MARINE and ANCHOR studies that showed the use of Vascepa® (icosapent ethyl) capsules significantly reduced apolipoprotein C-III (ApoC-III) levels. ApoC-III is a small protein that resides on various lipoproteins, and is an important regulator of lipoprotein and triglyceride (TG) metabolism.i This research is being presented today by Christie M. Ballantyne, M.D. from Baylor College of Medicine as part of a peer-reviewed poster session at the National Lipid Association Annual Scientific Sessions in Orlando, Florida.
"The significantly reduced Apo C-III levels with Vascepa in the MARINE and ANCHOR trials add to previously reported TG- and ApoB-lowering effects in patients from these studies," said Steven B. Ketchum, Ph.D., President of Research and Development, Senior Vice President, Amarin Corporation. "We are pleased to continue to analyze and share data from these trials that support the clinical value of Vascepa as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia."
MARINE and ANCHOR were 12-week, phase 3, double-blind studies that randomized patients to Vascepa 4 g/day, 2 g/day, or placebo. MARINE randomized 229 patients with TG ≥ 500 and ≤ 2000 mg/dL while ANCHOR randomized 702 patients at high risk for cardiovascular disease with TG ≥ 200 and < 500 mg/dL despite low-density lipoprotein cholesterol (LDL-C) control while on statin therapy. In the MARINE study, stable statin therapy was permitted but not required. In the ANCHOR study, patients were required to be at high risk for cardiovascular disease as defined by the NCEP ATP III guidelines and on stable statin dose (atorvastatin, rosuvastatin, or simvastatin).
This post-hoc analysis assessed the median percent change from baseline to study end in ApoC-III levels compared with placebo. ApoC-III levels were measured post hoc and lipid levels were measured as previously reported. Total ApoC-III levels were assessed in 148 and 612 patients in MARINE and ANCHOR, respectively. In MARINE, Vascepa 4 g/day and 2 g/day statistically significantly reduced ApoC-III levels by 25.1% (P < 0.0001) and 14.3% (P=0.0154) versus placebo, respectively. In ANCHOR, Vascepa 4 g/day and 2 g/day statistically significantly reduced ApoC-III levels by 19.2% (P < 0.0001) and 8.5% (P=0.0008) versus placebo, respectively. In the MARINE and ANCHOR studies Vascepa significantly reduced TG, Apo B- and ApoC-III levels without increasing LDL-C levels in patients at the dose of 4 g/day.
About Vascepa® (icosapent ethyl) capsules
Vascepa® (icosapent ethyl) capsules, known in scientific literature as AMR101, is a patented, pure-EPA omega-3 prescription product in a 1 gram capsule.
Indications and Usage
- Vascepa (icosapent ethyl) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.
- The effect of Vascepa on the risk for pancreatitis and cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined.
Important Safety Information for Vascepa
- Vascepa is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to Vascepa or any of its components and should be used with caution in patients with known hypersensitivity to fish and/or shellfish.
- The most common reported adverse reaction (incidence > 2% and greater than placebo) was arthralgia (2.3% for Vascepa, 1.0% for placebo).
FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM
Vascepa is under various stages of development for potential use in indications that have not been approved by the FDA, such as the potential indications that are under development in the REDUCE-IT trial. Nothing in this press release should be construed as promoting the use of Vascepa in any indication that has not been approved by the FDA.
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 and is available by prescription. For more information about Vascepa visit www.vascepa.com. For more information about Amarin visit www.amarincorp.com.
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, including statements about the clinical importance of certain parameters and the impact of Vascepa on such parameters. 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 reviews and approvals, including the risk that historical clinical trial results may not be predictive of future results in replicated in larger patient populations and that studied lipid parameters may not have clinically meaningful effect or support regulatory approvals. 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.
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i Ooi EM, et al. Clin Sci (Lond). 2008;114:611-24.
CONTACT: Amarin contact information: Michael Farrell or Joseph Bruno Investor Relations and Corporate Communications Amarin Corporation In U.S.: +1 (908) 719-1315 firstname.lastname@example.org
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