Amarin Corporation plc, 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) to add Chemport, Inc. as an additional Vascepa(R) (icosapent ethyl) active pharmaceutical ingredient (API) supplier.
“This sNDA approval of Chemport as a supplier of Vascepa marks another significant step for Amarin toward the goal of expanding our global supply chain to support expected Vascepa demand, diversify our supply base, and ensure cost-efficient supply,” stated Joseph Zakrzewski, Chairman and Chief Executive Officer of Amarin. “The addition of Chemport as an approved API supplier supplements Amarin’s current proven API supply source, Nisshin Pharma, Inc.”
The addition of Chemport 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 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 a pending sNDA for a third API supplier (BASF) and has plans for the submission of a fourth supplier in 2013.