BEDMINSTER, N.J. and DUBLIN, Ireland, Aug. 8, 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 Q2, the quarter ended June 30, 2013, and provided an update on company operations.
Key Amarin accomplishments since March 31, 2013 include:
- Recognized $5.5 million in product revenue from Vascepa sales in Q2, the first full quarter of Vascepa sales ($1.8 million in net value of Vascepa was deferred at the end of Q2 for product sold to wholesalers but not recognized as revenue under GAAP)
- Normalized prescriptions, based upon data from Symphony Health, increased in Q2 to 47,335 from 10,484 in Q1, comprised of normalized prescriptions from February and March only
- Improved formulary access by increasing number of lives covered with Tier 2 status to greater than 72 million with over 190 million lives covered on formulary overall
- Increased the number of physicians prescribing Vascepa to over 9,000
- Advanced planning and preparation for the anticipated launch of Vascepa for the ANCHOR indication, progressing towards advisory committee date of October 16, 2013 and PDUFA date of December 20, 2013
- Reported statistically significant reductions in median particle concentrations of total very-low-density lipoprotein (VLDL) by 12.2%, total low-density lipoprotein (LDL) by 7.7%, and small LDL particles by 13.5% when Vascepa 4 g/day was added to optimized statin therapy for 12 weeks, compared with placebo, in post-hoc analyses of the ANCHOR Phase 3 clinical trial data
- Continued to enroll patients in the REDUCE-IT cardiovascular outcomes trial in which the mean and median baseline triglyceride, or TG, levels in patients participating in the study to date are >200 mg/dL, a level which is intentionally higher than studied in recently conducted outcomes trials of other prescription lipid modifying therapies
- Increased patents issued or allowed in the United States to 27, adding 5 in Q2, which include multiple claims covering the administration of pure EPA to lower triglycerides with or without statin therapy (16 year-to-date), all but two of the 27 have patent terms extending into 2030, with more than 30 additional patent applications being prosecuted in the United States alone
- Expanded approved active pharmaceutical ingredient, or API, suppliers for Vascepa from one to three with sNDA approvals for BASF and Chemport Inc.
- Completed an equity financing in July resulting in approximately $121.1 million in estimated net proceeds which, when combined with the company's $149.4 million of cash on June 30, 2013, provides a solid financial foundation from which to further grow the company and seek profitability
"Since the end of Q1, revenues, prescription levels, prescribing physicians and lives covered under Tier 2 have all more than doubled," said Joseph Zakrzewski, Chairman and Chief Executive Officer of Amarin. "We have witnessed the awareness, knowledge level and utilization of Vascepa strengthen and expand across our group of targeted physicians. The efficacy and safety profile of Vascepa for its approved indication continue to be well received and we plan to continue to drive increased physician awareness and managed care coverage to further grow revenues. In addition, we believe we are well positioned for approval by the U.S. Food and Drug Administration, or FDA, in December to expand Vascepa labeling from our approved MARINE indication to the significantly larger population represented by our proposed ANCHOR indication."