BEDMINSTER, N.J. and DUBLIN, Ireland, Feb. 28, 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 and year ended December 31, 2012 and provided an update on company operations.
Key Amarin accomplishments since the quarter ended September 30, 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 lower triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia)
- Hired and trained U.S. sales team, including 275 sales representatives with extensive cardiovascular selling experience and relationships with healthcare professionals targeted for Vascepa along with key sales and marketing hires for Amarin's commercial team
- Stocked Vascepa at wholesalers and leading pharmacies
- Achieved >160 million lives covered by payors
- Submitted sNDA (supplemental New Drug Application) seeking approval in the United States of Vascepa for use in a second indication (ANCHOR)
- Submitted two sNDAs for additional active pharmaceutical ingredient (API) suppliers: Chemport and BASF
- Strengthened supply chain with an exclusive agreement entered into by a consortium of companies, led by Slanmhor Pharmaceuticals, Inc., to be Amarin's fourth Vascepa API supplier
- Increased patents issued or allowed to 18 in the United States, a majority of which have patent terms extending into 2030, with more than 30 additional U.S. patent applications being prosecuted
- Completed dosing of a fixed-dose combination study with Vascepa and a leading statin
- Publication of MARINE and ANCHOR Phase 3 trial results in The American Journal of Cardiovascular Drugs
- Strengthened balance sheet through successful completion of a $100M non-dilutive, hybrid debt financing resulting in a year-end cash balance of $260.2 million
"In 2012, Amarin received FDA approval of Vascepa capsules for the use in its initial indication, the MARINE indication," said Joseph Zakrzewski, Chairman and Chief Executive Officer of Amarin. "In early 2013, we launched Vascepa for the MARINE indication and submitted a sNDA with the FDA seeking approval for the ANCHOR indication, which would enable promotion of Vascepa to a significantly larger patient population. These significant achievements have been supported by considerable progress on multiple fronts, including the strengthening of our supply chain, expanding our patent protection for Vascepa and building a seasoned and capable commercial team. We look forward to continued progress in 2013."