Vascepa supply update
In the fourth quarter of 2012, Amarin submitted two sNDAs, one each for two additional active pharmaceutical ingredient (API) suppliers for Vascepa: BASF and Chemport. Both of these sNDA filings were approved in April 2013. Qualification of these suppliers is part of Amarin's strategy to expand its supply chain to provide greater capacity to meet anticipated demand, enable supply diversification and flexibility and introduce cost competition among high quality suppliers. With the approval of these suppliers, Amarin now has three qualified API suppliers for Vascepa, enabling Amarin to potentially reduce supply costs by 50% or more.
Vascepa exclusivity update
Amarin continues to make significant progress in its effort to expand patent protection for Vascepa and now has 22 patents issued or allowed in the United States with over 30 additional U.S. patent applications being prosecuted. This patent portfolio includes claims covering Vascepa's pharmaceutical composition and methods of use for the MARINE indication, ANCHOR indication and other potential uses of Vascepa. Amarin is also pursuing patent applications related to Vascepa in multiple jurisdictions outside the United States. All but two of the granted patents have expiry dates extending into 2030 and the majority of patent applications, if and when allowed, are anticipated to have expiry dates in or beyond 2030. Patent protection for Vascepa is augmented by protection provided by trade secrets, manufacturing barriers to entry and three- or five-year regulatory exclusivity.REDUCE-IT and other Vascepa-related clinical development Amarin continues to progress patient enrollment in its REDUCE-IT cardiovascular outcomes study with more than 4,000 patients enrolled in the study to date. Amarin anticipates continuing to enroll patients in this study throughout 2013. Results of the study will not be available until a specified number of cardiovascular events have been observed, the timing of which is not expected in the near-term.
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