Amarin Announces Submission of a Supplemental New Drug Application for BASF as Additional Vascepa(R) Active Pharmaceutical Ingredient Supplier
BEDMINSTER, N.J. and DUBLIN, Ireland, Jan. 2, 2013 -- Amarin Corporation plc (AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today the late December 2012 submission of a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval for BASF as an additional Vascepa(R) (icosapent ethyl) active pharmaceutical ingredient (API) supplier.
"This sNDA submission for BASF follows the recent sNDA submission for Chemport and marks our third Vascepa API supplier sNDA submission, with a submission for the addition of a fourth planned supplier expected in the first half of 2013," stated Joseph Zakrzewski, Chairman and Chief Executive Officer of Amarin. "The BASF submission represents an additional step toward the goal of expanding our global supply chain to support expected Vascepa demand, diversify our supply base and ensure cost-efficient supply."
This submission contributes to the planned expansion of the Vascepa manufacturing supply chain and is additional progress toward Amarin's goal to protect the commercial potential of Vascepa to beyond 2030 through a combination of patent protection, regulatory exclusivity, trade secrets and by taking advantage of manufacturing barriers to entry. Along with this planned expansion in supply, Amarin's significant progress includes expansion of patent protection for Vascepa in the United States with 11 Amarin patents either issued or allowed and over 30 additional patent applications being prosecuted. Amarin is also pursuing patent applications related to Vascepa in multiple jurisdictions outside the United States.
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. Vascepa(R) (icosapent ethyl), Amarin's first FDA approved product, is a patented, ultra pure omega-3 fatty acid product comprising not less than 96% EPA. For more information about Vascepa visit www.vascepa.com. For more information about Amarin visit www.amarincorp.com.
The Amarin Corporation plc logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=13817
This press release contains forward-looking statements, including statements about the manufacturing capacity and qualification of Vascepa suppliers and the timing and likelihood of regulatory submissions and approvals, the timing of commercial launch of Vascepa and Amarin's ability to protect the commercial potential of Vascepa. 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 uncertainties associated generally with dependence on third parties, research and development, clinical trials and related regulatory submissions and approvals; events that could interfere with the issuance of a patent, or once issued, the continued validity or enforceability of a patent; Amarin's ability to maintain adequate patent protection and successfully enforce patent claims against third parties; commercializing Vascepa without violating the intellectual property rights of others; obtain regulatory exclusivity and take advantage of manufacturing barriers to entry. 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.
Amarin contact information:
Stephen D. Schultz
Investor Relations and Corporate Communications
In U.S.: +1 (908) 719-1315