BEDMINSTER, N.J. and DUBLIN, Ireland, Aug. 26, 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 submission of a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval for Novasep Group, S.A.S., through its subsidiary Finorga S.A.S., as an additional Vascepa® (icosapent ethyl) active pharmaceutical ingredient (API) supplier. Novasep is part of the previously disclosed Slanmhor consortium with which Amarin announced a global supply agreement in 2012.
Novasep, a global leader in purification technologies and API manufacturing, is building the world's largest chromatography plant using its proprietary chromatography technologies to produce API on behalf of the Slanmhor consortium and Amarin. Amarin anticipates the Novasep facility, located in Mourenx, France, to be qualified and operational for manufacturing in 2014.
"This sNDA submission for Novasep brings to four the total number of suppliers that are approved or in regulatory review for Vascepa API production, including Nisshin Pharma, Inc. and following the recent FDA approvals of both BASF and Chemport as API suppliers for the product," stated Joseph Zakrzewski, Chairman and Chief Executive Officer of Amarin. "The Novasep 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. As previously stated, the continued addition of these suppliers will potentially lead to API cost reductions of up to 50% or more and help us reach a steady state gross margin as a percentage of product revenues in the high seventies to low eighties."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 27 Amarin patents either issued or allowed and over 30 additional patent applications being prosecuted in the United States. Amarin is also making significant progress with its patent applications related to Vascepa in multiple jurisdictions outside the United States, including the May 2013 patent grant by the European Patent Office covering the use of Vascepa based on the results from the MARINE trial.