Amarin Submits Supplemental NDA for Novasep as Fourth Vascepa Active Pharmaceutical Ingredient Supplier
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