BEDMINSTER, NJ and DUBLIN, IRELAND -- (Marketwired) -- 05/28/15 -- Amarin Corporation plc(NASDAQ: AMRN), announced today that Judge Randolph D. Moss of the federal district court for the District of Columbia has granted Amarin's motion for summary judgment in the company's lawsuit against the United States Food and Drug Administration (FDA) seeking an order requiring FDA to recognize five-year, New Chemical Entity (NCE), marketing exclusivity for Vascepa®(icosapent ethyl) capsules.
Amarin believes based on the court's ruling that Vascepa is entitled to five-year marketing exclusivity starting from FDA's approval of Vascepa in July 2012, thus extending NCE exclusivity through July 25, 2017. The ruling also confirms that acceptance by FDA of abbreviated new drug applications ("ANDAs") for generic versions of Vascepa is not permitted until July 2016. The related statutory 30-month stay triggered by patent litigation following generic application resubmissions in July 2016 would then expire in January 2020. An appeal of the court's decision can be filed within 60 days.
Amarin has multiple patents covering Vascepa that expire in 2030. With this motion granted and FDA's acceptance of ANDAs not permitted, Amarin plans to move to dismiss pending Vascepa patent litigation in connection with ANDA filings previously submitted.
"Congratulations to the extended Amarin team for delivering on this value-enhancing operational goal," stated John Thero, President and Chief Executive Officer of Amarin. "NCE exclusivity helps solidify Vascepa's commercial potential and helps demonstrate Vascepa's status as a significant and novel treatment option in the management of severely high triglycerides. Amarin's goal is to protect the commercial potential of Vascepa to beyond 2030. NCE regulatory exclusivity contributes toward this goal by complementing one of the most extensive patent portfolios covering a single product in the industry and existing manufacturing barriers to entry."
(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.
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 Amarin's plans to end pending ANDA-related patent litigation, require later resubmission pending generic applications; statements about maintaining Vascepa exclusivity including barriers to entry that may protect Vascepa against competition and Amarin's plan to protect the commercial potential of Vascepa through patents and other circumstances and means. 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: a determination by FDA or other interested parties to appeal or intercede in the
court decision and a win on such appeal or the unwillingness of authorities to dismiss proceedings until any such appeal is heard; events that could interfere with 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 trials and related regulatory approvals and exclusivity grants. 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.
Availability of other information about Amarin
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.
Amarin contact information:
Investor Relations and Corporate Communications
In U.S.: +1 (908) 719-1315
In U.S.: +1 (646) 378-2954
In U.S.: +1 (212) 508-9651
Source: Amarin Corp. Plc
News Provided by Acquire Media