Amarin Corporation Plc (NASDAQ:AMRN) has announced that it has reached a patent lawsuit settlement agreement with Apotex Inc. The settlement agreement solves the patent suit that could have emerged as a result of the previously disclosed ANDA that Apotex filed with the FDA.
Amarin settles patent suit with Apotex
The new drug application was amended in May, and it sought approval for a generic version of VASCEPA grounded on the MARINE study. Amarin is appealing to the Nevada District Court’s invalidity patent ruling that ruled in favor of Dr. Reddy’s Laboratories and Hikma Pharmaceuticals, which are generic companies. However, since Apotex is not part of the suit, the Amarin suit against Apotex will be pursued independently.
According to terms of the settlement, Apotex should not sell the VASCEPA generic version in the US until August 9, 2029, or earlier, depending on some customary circumstances. This is the same period that was provided for in the 2018 settlement with Teva Pharmaceuticals. The special circumstances will include Amarin’s failure in its appeal at the Nevada District Court following the Federal circuit mandate issuance. Similarly, the settlement agreement solves significantly any potential suits in the future with Apotex that could have resulted in the connection to VASCEPA’s cardiovascular risk reduction indication based on the REDUCE-IT study.
Amarin release REDUCE-IT study results
Amarin has released the results of the REDUCE-IT study, and it presented the data at the ADA 80th Scientific Session. Study results indicated a significant reduction of about 23% in first and aggregate major cardiovascular adverse effects following administration of4g per day of VASCEPA in diabetes patients. Similarly, 30% and 29% reductions were shown in the first and total hard MACE, respectively, the secondary combination endpoint.
The company’s Chief Scientific Officer, Stephen Ketchum, indicated the REDUCE-IT Diabetes group’s analyses enhance the understanding of the potential of VASCEPA in benefiting Diabetes patients. Ketchum added that the data in the company’s analyses demonstrate consistent results across the populations and also validates the role of VASCEPA in reducing cardiovascular burden in diabetes patients.