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Amarin Corp Plc (AMRN) Posts Q3 adj.Loss of 26c/Share; Updates on Vascepa Approvals, Exclusivity

November 8, 2012 4:29 PM EST
Amarin Corp Plc (NASDAQ: AMRN) reported Q3 EPS of ($0.26), $0.04 worse than the analyst estimate of ($0.22).

Vascepa regulatory update

On July 26, 2012, the U.S. Food and Drug Administration (FDA) approved Vascepa (icosapent ethyl) capsules (formerly known as AMR101) as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (TG >500mg/dL) hypertriglyceridemia. The only reported adverse reaction with an incidence >2% and greater than placebo in Vascepa treated patients was arthralgia (2.3% for Vascepa, 1.0% for placebo). The approved label shows that Vascepa, compared to placebo, reduces TG's, Apo B, non-HDL-C, total cholesterol and VLDL-C without increasing LDL-C.

Amarin expects to file sNDAs for two additional active pharmaceutical ingredient (API) suppliers before the end of 2012 and for a third API supplier in the first quarter of 2013. This brings to four, the total number of API suppliers for Vascepa and is part of Amarin's strategy to mitigate risk through multiple suppliers.

Amarin's sNDA has been prepared for the patient population studied in the ANCHOR Phase 3 trial. Consistent with prior guidance, Amarin plans to file this sNDA once its cardiovascular outcomes study, REDUCE-IT, is substantially underway. As previously discussed in Amarin's second quarter 2012 results conference call, based on continued REDUCE-IT progress Amarin anticipates submitting this sNDA to the FDA no later than the end of February 2013 resulting in an anticipated PDUFA action date for the ANCHOR sNDA before the end of 2013.

Vascepa exclusivity update

Amarin continues to make significant progress in its effort to expand the patent protection for Vascepa in the United States and now has 8 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, including the application for Amarin's MARINE method of use patent in Europe for which Amarin previously announced receipt of an Intention to Grant letter. Amarin's goal is to protect the commercial potential of Vascepa to beyond 2030 through patent protection, regulatory exclusivity and trade secrets and by taking advantage of manufacturing barriers to entry.

Amarin expects the FDA to make a determination to award Vascepa either three-years of marketing exclusivity or five-years of marketing exclusivity. A marketing exclusivity determination may help to clarify the ultimate path for Vascepa commercialization among Amarin's three previously-disclosed potential paths: an acquisition of Amarin, a strategic collaboration, or self-commercialization, the latter of which could include third-party support.

For earnings history and earnings-related data on Amarin Corp Plc (AMRN) click here.


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