Amarin Submits Supplemental NDA to FDA for BASF as Additional Vascepa Active Pharmaceutical Ingredient Supplier

Amarin Corporation
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® (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,
See full press release

Posted In: NewsGuidanceContractsManagementGlobal