BEDMINSTER, NJ and DUBLIN, IE--(Marketwired - November 17, 2014) - Amarin Corporation Plc (AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today the presentation of new data and related analyses from the MARINE and ANCHOR phase 3 studies. The data show that use of Vascepa® (icosapent ethyl) capsules significantly reduced remnant-like particle cholesterol (RLP-C) levels -- a cardiovascular risk factor -- including significant placebo-adjusted reductions in RLP-C in studied patient populations with triglyceride (TG) levels ≥ 200 mg/dL and ≥ 500 mg/dL, including patients that received statin therapy. The data were presented today by Dr. Christie M. Ballantyne as part of a moderated poster session at the American Heart Association Scientific Sessions in Chicago.
Remnant-like particle cholesterol is an important emerging risk factor for cardiovascular disease and represents the cholesterol content of a subset of triglyceride-rich lipoproteins (TRL) called remnants. In the fasting state this subset of TRLs is comprised of very low-density lipoproteins (VLDL) and intermediate-density lipoproteins (IDL), and in the non-fasting state includes these two types of lipoproteins together with chylomicron remnants.1-3 Elevated plasma TG levels are a marker of elevated remnant cholesterol and are associated with increased risk for cardiovascular disease.4-6
"As we have seen in multiple studies to date, RLP-C is a significant predictor of cardiovascular disease, and is known to be atherogenic," said Christie M. Ballantyne, M.D., Baylor College of Medicine and the Methodist DeBakey Heart and Vascular Center, Houston, Texas, and principal investigator of the ANCHOR trial. "These analyses of data from the MARINE and ANCHOR studies show significant reductions in RLP-C in patients treated with Vascepa compared to placebo, particularly in those patients with higher triglyceride levels and those being treated concomitantly with statin therapy."
MARINE and ANCHOR were each 12-week, double-blind phase 3 studies that randomized patients to Vascepa 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).
These analyses assessed the median difference in percent change from baseline to study end in RLP-C levels compared with placebo. RLP-C levels were measured with an immunoseparation assay in 218 and 252 patients in MARINE and ANCHOR, respectively. Compared with placebo, Vascepa (4 g/day) significantly reduced median RLP-C levels by 29.8% (P=0.0041) and by 25.8% (P=0.0001) in the MARINE and ANCHOR studies, respectively. Compared with placebo, Vascepa (4 g/day) significantly reduced RLP-C in statin-treated patients in the MARINE study, significantly reduced RLP-C in patients receiving moderate- to high-intensity statins in the ANCHOR study, and significantly reduced RLP-C in subgroups with higher baseline TG levels in both studies. RLP-C reductions were seen to a greater extent in subgroups with higher baseline TG levels in both studies.
About Vascepa® (icosapent ethyl) capsules
Vascepa® (icosapent ethyl) capsules, known in scientific literature as AMR101, is a highly-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). There was no reported adverse reaction > 3% and greater than 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. 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. Amarin's clinical program includes commitment to an ongoing outcomes study. Vascepa® (icosapent ethyl), Amarin's first FDA approved product, is a highly-pure, EPA-only, omega-3 fatty acid product 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 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.
Availability of other information about Amarin
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