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Last Update: 10-May-13 07:44 ET
Amarin shares rise 2% despite miss on earnings
Amarin (AMRN) reported first quarter GAAP loss of $0.41 per share, $0.02 worse than the Capital IQ consensus of ($0.39). Revenues were $2.34 million vs $4.67 million Capital IQ Consensus Estimate. Commercialization update: Amarin's direct sales force, consisting of approximately 275 sales professionals, made sales calls to clinicians for two months in Q1 2013. Amarin reports that, since launch, access to clinicians has been good, and that it has yet to hear any significant negative reaction to the efficacy or safety profile of Vascepa. Vascepa additional indication progress. In April 2013, as previously announced, the FDA accepted for review Amarin's sNDA for the ANCHOR indication that, upon approval, would enable Amarin to market and sell Vascepa for use in the ANCHOR indication. The FDA assigned a PDUFA action date of December 20, 2013 for this sNDA, which date is consistent with the standard FDA ten-month review period. The safety results from the ANCHOR trial are included in the current label for Vascepa. At a daily Vascepa dose of 4 grams, all of the primary and secondary efficacy endpoints of the ANCHOR trial were achieved. As a result, Amarin is optimistic that the FDA will approve Vascepa for this indication. 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...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.
