Submission for Indication Studied in the ANCHOR Phase 3 Clinical Trial Under Special Protocol Assessment Agreement With FDA
BEDMINSTER, N.J. and DUBLIN, Ireland, Feb. 26, 2013 (GLOBE NEWSWIRE) -- Amarin Corporation plc (AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today that it has submitted a Supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration (FDA) seeking approval for the marketing and sale of Vascepa(R) (icosapent ethyl) capsules for use as an adjunct to diet in the treatment of adult patients with high triglycerides (TG >=200 mg/dL and <500 mg/dL) with mixed dyslipidemia. Amarin expects to hear within 74 days from the FDA whether the sNDA submission has been accepted for review (inclusive of the standard 60-day review and the standard 14-day communication periods).
"This submission marks another significant milestone achieved for Amarin. Data from our pivotal Phase 3 placebo-controlled ANCHOR study showed that Vascepa is unique in that it significantly lowered both triglycerides and LDL-cholesterol on top of optimized statin therapy and exhibited a safety and tolerability profile similar to placebo, unlike the clinical results of other triglyceride-lowering therapies," said Joseph S. Zakrzewski, Chairman and Chief Executive Officer of Amarin. "The submission of this sNDA for Vascepa follows the FDA approval and recent launch of Vascepa for use as an adjunct to diet to lower triglyceride levels in adult patients with severe (TG >=500 mg/dL) hypertriglyceridemia. If approved for the ANCHOR indication, Vascepa will be the only approved prescription omega 3 therapy for cardiovascular health management in this patient population (TG >=200 mg/dL and <500 mg/dL with mixed dyslipidemia) and will represent the next generation of lipid management for potentially millions of patients."
It is estimated that one in five, or nearly 40 million U.S. adults, have triglyceride levels greater than 200 mg/dL. In the United States alone, it is estimated that 75 million adults have triglyceride levels greater than 150 mg/dL (population studied in the ongoing Vascepa REDUCE-IT cardiovascular outcomes study), including 4 million people with severe hypertriglyceridemia (Vascepa approved indication) and 36 million people with high triglyceride levels (the triglyceride range studied in the ANCHOR trial). Clinical treatment guidelines include recommendations for triglyceride reductions in adults with triglyceride levels greater than 200 mg/dL1 and it is believed that each group represents a potential multi-billion dollar market opportunity. In the top seven world markets it is estimated that the number of people with elevated triglyceride levels is at least two times that of the United States alone.
1Executive Summary of the Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). JAMA. May 16, 2001;285(19):2486-97
About Vascepa(R) (icosapent ethyl) capsules
Vascepa(R) (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.
FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM
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(R) (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
This press release contains forward-looking statements, including statements about regulatory submissions and the timing and potential for FDA acceptance, review and approval of such submissions, the efficacy and safety of Amarin's product candidates and market opportunities for Vascepa and the clinical importance of Vascepa. 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 the following: uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, including whether Amarin has, in the FDA's view, reached substantial enrollment in its REDUCE-IT outcomes study of Vascepa, a prerequisite to the FDA's acceptance of the sNDA for the ANCHOR indication. 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 lower 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.
Stephen Schultz or Joseph Bruno
Investor Relations and Corporate Communications
In U.S.: +1 (908) 719-1315