BEDMINSTER, N.J., and DUBLIN, Ireland, March 7, 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 that the United States Patent and Trademark Office (USPTO) has published notification of a Notice of Allowance for Amarin's U.S. Patent Application Serial Number 13/614,111titled "Stable Pharmaceutical Compositions and Methods of Using the Same." This application includes claims intended to protect the proposed Vascepa® (icosapent ethyl) indication based on Amarin's Phase 3 ANCHOR clinical trial results. In late February, Amarin filed a Supplemental New Drug Application for the Vascepa ANCHOR indication with the U.S. Food and Drug Administration (FDA), and expects an FDA action date on the application before the end of 2013.
A Notice of Allowance is issued after the USPTO makes a determination that a patent can be granted from an application. The issued patent would have a term that expires no earlier than in 2030. Amarin plans to list this patent in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book, after issuance of the patent and the anticipated approval of Vascepa in the ANCHOR indication.
The claims in this allowed application relate to the planned Vascepa ANCHOR indication and cover methods of treating mixed dyslipidemia through the daily administration of 2500 mg to 5000 mg of highly pure EPA to a subject on any statin therapy.
"The claims in this allowed application cover the described method of administration of a pharmaceutical composition comprising EPA over a broader range of daily EPA doses and amounts of EPA per capsule including, for example, a daily dosing regimen of four capsules, each containing approximately 62.5% EPA and 37.5% of one or more other components," stated Joseph Zakrzewski, Chairman and Chief Executive Officer of Amarin. "The issuance of this Notice of Allowance represents the broadest ANCHOR patent to date."
This application is part of an expanding patent portfolio for Amarin with 19 patent applications now either issued or allowed with the USPTO and over 30 additional applications pending in the United States. Amarin is also pursuing patent applications related to Vascepa in multiple jurisdictions outside the United States, including the application for Amarin's MARINE method of use patent in Europe for which Amarin has announced receipt of an Intention to Grant letter.
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 and available by prescription. For more information about Vascepa visit www.vascepa.com. For more information about Amarin visit www.amarincorp.com.
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Forward-looking statements
This press release contains forward-looking statements, including statements about whether the subject patent would be issued and adequately protect Vascepa against competition, the expiration date of the pending patent, Amarin's plan to list the patent, when issued, in FDA's Orange Book assuming FDA approval of the ANCHOR indication, the anticipated approval of Vascepa in the ANCHOR indication, Amarin's plan to protect the commercial potential of Vascepa, the future status of pending patent applications, planned regulatory submissions and expected action dates. 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: events that could interfere with the issuance of a patent, or once issued, the continued validity or enforceability of a patent; Amarin's ability generally to maintain adequate patent protection and successfully enforce patent claims against third parties; commercializing Vascepa without violating the intellectual property rights of others; and uncertainties associated generally with research and development, clinical trial enrollment in Amarin's REDUCE-IT trial and related regulatory submissions, action dates 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 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.
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.