Amarin Announces FDA Award of Three-Year Exclusivity for Vascepa(R) (icosapent ethyl) Capsules
February 21, 2014
Regulatory Exclusivity Supplements 40 Issued and Allowed U.S. Patents to Date
BEDMINSTER, N.J. and DUBLIN, Ireland, Feb. 21, 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 that the U.S. Food and Drug Administration (FDA) has awarded three years of marketing exclusivity to Vascepa® (icosapent ethyl) capsules in connection with the July 26, 2012 approval of Vascepa pursuant to the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act. Such exclusivity extends through July 25, 2015 and is expected to be supplemented by a 30-month stay under the Hatch-Waxman Amendments that would be triggered after patent infringement litigation initiated by Amarin following valid notice to Amarin of the acceptance of an application to the FDA seeking approval of a generic version of Vascepa. FDA marketing exclusivity is separate from, and in addition to, patent protection, trade secrets and manufacturing barriers to entry which also help protect Vascepa against generic competition..
"Amarin is reviewing the FDA's reasoning for granting Vascepa three-year, rather than five-year, exclusivity, and evaluating whether to challenge the decision," stated John Thero, President and Chief Executive Officer of Amarin. "Over the past year, Amarin has significantly bolstered its patent position for Vascepa thereby decreasing the relative value of FDA marketing exclusivity in protecting Vascepa. Amarin now has 40 issued and allowed U.S. patents that provide the primary means to protect the exclusivity of Vascepa to 2030. These patents, all but two of which expire in 2030, are anticipated to protect the exclusivity of Vascepa well beyond the FDA marketing exclusivity period and to augment the protection afforded by Amarin's trade secrets and existing manufacturing barriers to entry."
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 whether Amarin will challenge the FDA exclusivity grant for Vascepa in favor of five-year, NCE exclusivity, whether FDA regulatory exclusivity, patents, trade secrets and manufacturing barriers to entry would be sufficient to protect Vascepa against competition. 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 maintaining trade secrets and manufacturing barriers to entry. 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.
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Investors and others should note that we communicate with our investors and the public using our company website (www.amarincorp.com), our investor relations website (http://www.amarincorp.com/investor-splash.html), including but not limited to investor presentations and investor FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in Amarin to review the information that we post on these channels, including our investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.CONTACT: Amarin contact information: Joseph Bruno Director, Investor Relations and Corporate Communications Amarin Corporation plc In U.S.: +1 (908) 719-1315 firstname.lastname@example.org