Re: Farmas USA
Otro mas!
http://investor.amarincorp.com/secfiling.cfm?filingid=1193125-13-184225
Amarin Announces Approval of Supplemental New Drug Application for BASF as Additional Vascepa(R) Active Pharmaceutical Ingredient Supplier
BEDMINSTER, N.J. and DUBLIN, Ireland, April 30, 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 approval of the Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for BASF as an additional Vascepa® (icosapent ethyl) active pharmaceutical ingredient (API) supplier.
"This sNDA approval of BASF as a supplier of Vascepa follows the recent sNDA approval to add Chemport, Inc. as a Vascepa API supplier and brings the number of approved Vascepa API suppliers to three," stated Joseph Zakrzewski, Chairman and Chief Executive Officer of Amarin. "The BASF approval 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. The addition of BASF, along with Chemport, will lead to API cost reductions of up to 50% or more."
The addition of BASF 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 qualification of additional API suppliers, 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 plans for the submission of a fourth planned supplier in 2013.
AMRN