BEDMINSTER, N.J., and DUBLIN, Ireland, May 9, 2013 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a late-stage biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, today announced financial results for the quarter ended March 31, 2013 and provided an update on company operations.
Key Amarin accomplishments since the quarter ended December 31, 2012 include:
- Launched Vascepa ® (icosapent ethyl) capsules in the United States on January 28, 2013 for the MARINE indication (use as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia)
- Recognized $2.34 million in product revenue from Vascepa sales in Q1 in accordance with GAAP ($5.2 million in net value of Vascepa was sold to wholesalers in Q1, resulting in $2.9 million of deferred product revenue under GAAP in Q1)
- Secured formulary access for Vascepa with over 190 million lives now covered by payors without restrictions, including 40 million converted to Tier 2 in April and May
- Received Food and Drug Administration (FDA) acceptance for review of supplemental New Drug Application (sNDA) seeking approval for the marketing and sale of Vascepa for the ANCHOR indication (use as an adjunct to diet in the treatment of adult patients with high triglycerides (TG ≥200 mg/dL and <500 mg/dL) with mixed dyslipidemia)
- Reported statistically significant reductions of apolipoprotein C-III (Apo C-III) of 25.1% and 19.2%, compared to placebo, as demonstrated by Vascepa in post-hoc analyses of the MARINE and ANCHOR Phase 3 clinical trials, respectively
- Received FDA approval of two additional active pharmaceutical ingredient (API) suppliers, BASF and Chemport, for the manufacture of Vascepa giving Amarin three qualified API suppliers
- Increased patents issued or allowed in the United States to 22 (adding 11 in the first quarter alone, including 3 since our last patent announcement), all but two of which have patent terms extending into 2030, with more than 30 additional patent applications being prosecuted in the United States alone
"On January 28, 2013 Amarin launched Vascepa for use in its initial indication as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia, the MARINE indication," said Joseph Zakrzewski, Chairman and Chief Executive Officer of Amarin. "Since that day, we have seen meaningful progress in multiple areas of our commercialization strategy, including uptake in Vascepa utilization by physicians in both the specialty and primary care communities, the initial migration of managed care lives from Tier 3 to Tier 2 coverage, the continued expansion of our patent portfolio, the further strengthening of our supply chain, and the acceptance for review by the FDA of our sNDA for the ANCHOR indication, which, if approved, would enable promotion of Vascepa to a significantly larger patient population."