Consistent with prior guidance, Amarin plans to file a supplemental NDA (sNDA) for the use of Vascepa in the patient population studied in Amarin's ANCHOR Phase 3 trial. Prior to filing this sNDA, the FDA requires that Amarin's cardiovascular outcomes study, REDUCE-IT, be substantially underway. As previously stated, Amarin anticipates this planned sNDA submission to result in a Prescription Drug User Fee Act (PDUFA) action date for the ANCHOR sNDA in the second half of 2013.
Vascepa exclusivity update
A top priority for Amarin in the second quarter of 2012 was, and continues to be, the ongoing prosecution of the company's patent application portfolio. Amarin has made significant progress in its efforts to expand the patent protection for Vascepa in the United States with seven patents "in play," including issued U.S. Patent No. 8,188,146 (a pharmaceutical composition patent), a Notice of Allowance for U.S. Patent Application Serial Number 12/769,885 and published Reasons for Allowance on five other pending U.S. patent applications targeted at methods of using Vascepa to treat patients in the MARINE patient population. Amarin is also prosecuting over 25 additional patent applications in the United States and multiple patent applications outside the United States, including the application for Amarin's MARINE method of use patent in Europe for which Amarin recently announced receipt of an Intention to Grant letter. Amarin is also expecting to receive five-year new chemical entity (NCE) or three-year new product marketing exclusivity under the provisions of the Hatch-Waxman amendments to the Federal Food, Drug, and Cosmetic Act.
Amarin's goal is to protect the commercial potential of Vascepa to beyond 2030 through patent protection, regulatory exclusivity, trade secrets and taking advantage of manufacturing barriers to entry.
Amarin continues to anticipate commercial launch of Vascepa early in the first quarter of 2013 and continues to consider three potential paths for the marketing and sale of Vascepa: An acquisition of Amarin, a strategic collaboration, or self-commercialization, the latter of which could include third-party support. Regardless of whether Amarin launches Vascepa on its own or through a larger company, over the coming months Amarin plans to take various steps to build market awareness and otherwise prepare in advance of commercial launch which include, but are not limited to, finalizing the introduction of Vascepa to managed care plans to gain formulary access, building-up inventory levels and coordinating other pre-launch marketing activities.