BEDMINSTER, N.J. and DUBLIN, Ireland, May 30, 2013 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, today presented additional data on Vascepa® (icosapent ethyl) and its effect on lipoprotein particle concentration from the Phase 3 ANCHOR study at the National Lipid Association (NLA) 2013 Annual Scientific Session in Las Vegas, Nevada.
The data presentation titled, "Effects of Icosapent Ethyl on Lipoprotein Particle Concentration and the Fatty Acid Desaturation Index in Statin-treated Patients with Persistent High Triglycerides (the ANCHOR Study)", reported that Vascepa 4 g/day, when added to optimized statin therapy for 12 weeks, significantly reduced median particle concentrations of total very-low-density lipoprotein (VLDL) by 12.2%, total low-density lipoprotein (LDL) by 7.7%, and small LDL particles by 13.5% across the 12 week treatment period, compared with placebo.
The ANCHOR study, authored by Christie M. Ballantyne, M.D. and colleagues, investigated Vascepa as a treatment for high triglycerides (≥200 and <500mg/dL) in 702 patients with mixed dyslipidemia (two or more lipid disorders) on optimized background statin therapy who were at LDL-C (low-density lipoprotein cholesterol) goal, and who were also at high risk of cardiovascular disease. The original results, which were presented at the American Heart Association in 2011, highlighted that Vascepa 4 g/day demonstrated a significant median reduction in triglyceride levels, the primary endpoint, of 21.5%, as well as a significant median reduction in low-density lipoprotein cholesterol (LDL-C) of 6.2%, compared to the group of patients on optimized statin therapy and placebo.
Amarin also presented, or provided financial support for, research surrounding three additional topics at this year's NLA meeting, including:
- pharmacokinetic data showing the lack of drug-drug interaction when Vascepa was administered with atorvastatin, a commonly prescribed cholesterol lowering medication
- pharmacokinetic data showing the lack of drug-drug interaction when Vascepa was administered with warfarin, a commonly prescribed anticoagulant medication
- eicosapentaenoic acid (EPA) and its potential inhibition of the formation of membrane cholesterol crystalline domains
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
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.
Forward-looking statements
This press release contains forward-looking statements, including statements about the effects of Vascepa, as shown in clinical trials, to be accepted by regulatory agencies and, if approved, reflected in clinical results and the likelihood of regulatory submissions and approvals. 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 submissions and 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 Quarterly Report on Form 10-Q. 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.
Vascepa has been approved for use by the FDA as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Vascepa is under various stages of development for potential use in other indications that have not been approved by the FDA. 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.