Amarin Announces Approval of Supplemental New Drug Application for BASF as Additional Vascepa(R) Active Pharmaceutical Ingredient Supplier
BEDMINSTER, N.J. and DUBLIN, Ireland, April 30, 2013 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today the approval of the Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for BASF as an additional Vascepa® (icosapent ethyl) active pharmaceutical ingredient (API) supplier.
"This sNDA approval of BASF as a supplier of Vascepa follows the recent sNDA approval to add Chemport, Inc. as a Vascepa API supplier and brings the number of approved Vascepa API suppliers to three," stated Joseph Zakrzewski, Chairman and Chief Executive Officer of Amarin. "The BASF approval 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. The addition of BASF, along with Chemport, will lead to API cost reductions of up to 50% or more."
The addition of BASF 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 qualification of additional API suppliers, Amarin's significant progress includes expansion of patent protection for Vascepa in the United States with 19 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. In addition, Amarin has plans for the submission of a fourth planned supplier in 2013.
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® (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.
This press release contains forward-looking statements, including statements about the manufacturing capacity and qualification of Vascepa suppliers, potential product cost reductions from future supply sources, 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 Annual Report on Form 10-K. 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.
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Source: Amarin Corporation plc