04.18.13
Amarin Corp. has received FDA approval of its sNDA to add Chemport as an additional API supplier for Vascepa (icosapent ethyl). The addition of Chemport contributes to the expansion of Vascepa’s manufacturing supply chain and to Amarin's goal to protect the commercial potential of Vascepa beyond 2030 through a combination of patent protection and regulatory exclusivity.
"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," said 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."
Amarin has expanded patent protection for Vascepa in the U.S. with 19 patents and more than 30 additional patent applications being prosecuted. Amarin is also pursuing Vascepa patent applications in multiple jurisdictions outside the U.S. In addition, Amarin has a pending sNDA for a third API supplier (BASF) and has plans for the submission of a fourth in 2013.
"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," said 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."
Amarin has expanded patent protection for Vascepa in the U.S. with 19 patents and more than 30 additional patent applications being prosecuted. Amarin is also pursuing Vascepa patent applications in multiple jurisdictions outside the U.S. In addition, Amarin has a pending sNDA for a third API supplier (BASF) and has plans for the submission of a fourth in 2013.