UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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| Item 8.01 | Other Events |
On June 16, 2020, Amarin Corporation plc (“Amarin”) entered into a settlement agreement with Apotex Inc. (“Apotex”) that resolves patent litigation that would have resulted from the previously disclosed abbreviated new drug application (“ANDA”) filed by Apotex with U.S. Food and Drug Administration (“FDA”) and amended in May 2020 seeking approval of a generic form of VASCEPA® (icosapent ethyl) capsules based on the MARINE study.
As previously disclosed, Amarin is currently appealing to the U.S. Court of Appeals for the Federal Circuit a March 2020 patent invalidity ruling of the U.S. District Court for the District of Nevada in favor of generic companies Hikma Pharmaceuticals USA Inc. and Dr. Reddy’s Laboratories, Inc. Because Apotex is not a party to that litigation, it is not directly subject to related rulings. As such, patent litigation against Apotex would need to be pursued separately.
As part of the settlement agreement, Apotex may not sell a generic version of VASCEPA in the United States until August 9, 2029 (the same such date provided for under the 2018 settlement agreement with Teva Pharmaceuticals USA, Inc.) or earlier under certain customary circumstances. As currently relevant, such circumstances include if Amarin is not successful in its pending appeal of the March 2020 Nevada district court decision after issuance of the Federal Circuit mandate following any Federal Circuit rehearing or en banc review. The agreement also substantially resolves future litigation with Apotex that could have ensued related to the December 2019 cardiovascular risk reduction indication of VASCEPA based on the REDUCE-IT® study. The descriptions above are summaries and are qualified in their entirety by the terms of the agreement, which are confidential. The agreement is subject to review by applicable federal authorities.
Forward-looking statements
This Current Report on Form 8-K contains forward-looking statements related to Amarin’s patents and interpretation of related settlement agreements and litigation. 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 herein include the following: 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; and Amarin’s understanding of current settlement and litigation positions and potential outcomes. 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.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: June 16, 2020 |
Amarin Corporation plc | |||||
| By: |
/s/ John Thero | |||||
| John Thero | ||||||
| President and Chief Executive Officer | ||||||