BEDMINSTER, N.J. and Dublin, Ireland, May 24, 2018 (GLOBE NEWSWIRE) – Amarin Corporation plc (NASDAQ:AMRN), a biopharmaceutical company, which focuses on the commercialization and development of therapeutic drugs to improve cardiovascular health, today announced a settlement agreement with Teva Pharmaceuticals USA, Inc. (Teva) to resolve patent disputes® vascepa (icosapent ethyl) previously notified to Amarin , as this is a new pharmaceutical application abbreviated by Teva that is seeking approval of generic forms of Vascepa capsules (icosapent ethyl) by the U.S. Food and Drug Administration (FDA). This patent dispute continues in the United States District Court for the District of Nevada with parties West-Ward Pharmaceuticals Corp. and Dr. Reddy`s Laboratories, Inc. and their related companies. Amarin on Tuesday accepted a comparison with generics maker Apotex, which would push a Vascepa impersonator back to August 2029 if the New Jersey drug maker stirs its focus on reintroducing Vascepa`s underlying patents. In accordance with the settlement agreement between Amarin and Teva, Teva may, under normal circumstances, begin selling its generic version of Vascepa in the United States on August 9, 2029 or earlier. In addition, according to the agreement, Amarin will pay Teva $2 million. For a generic drug to be marketed in the United States, the generic company`s ANDA must be approved by the FDA. In this comparison, in accordance with the terms of Amarin`s 2018 transaction agreement with Teva, Amarin does not undertake to supply Apotex at any time with icosapent ethyl.
Outside the United States, Amarin holds various patents and regulatory exclusivity rights on the ethyl icosapent that are not part of this regime and are not part of a current litigation. As part of the transaction agreement, Apotex may not sell a generic version of VASCEPA in the United States until August 9, 2029 (the same date stipulated in the 2018 transaction agreement with Teva Pharmaceuticals USA, Inc. Inc. (Teva) or previously under certain usual circumstances. As currently relevant, these circumstances include whether Amarin was not successful in his appeal in March 2020 Nevada District Court after awarding the federal circuit warrant after each federal circuit sample or under review bench. The agreement also essentially resolves future disputes with Apotex, which could have been invoked in the VASCEPA Cardiovascular Risk Mitigation Notice in December 2019, based on the REDUCE-IT® study. Other terms of the agreement are confidential. The agreement is subject to verification by the relevant federal authorities. This press release contains forward-looking statements about Amarin`s patents and the interpretation of transaction agreements and related litigation. These forward-looking statements are not promises or guarantees and involve significant risks and uncertainties. Factors that could lead to actual results significantly different from those described above include events that could affect the validity or applicability of a patent; and Amarin`s ability to maintain adequate patent protection in general and to successfully enforce claims against third parties, as well as the company`s understanding of current comparison and process positions and potential outcomes.