Amarin Corporation (AMRN) announced that its cardiovascular outcomes study, REDUCE-IT (Reduction of Cardiovascular Events with EPA – Intervention Trial), has enrolled more than 6,000 patients. The study, which commenced in Dec 2011, is evaluating Vascepa’s safety and efficacy as an adjunct therapy in reducing first major cardiovascular events in a high risk patient population on statin therapy.
REDUCE-IT, a multinational, prospective, randomized, double-blind, placebo-controlled, parallel-group study, is being carried at 400 sites across 11 countries. While the control arm includes patients on statin therapy plus placebo, the active arm comprises patients on statin therapy plus Vascepa (4g/day).
In Jul 2013, Amarin had raised approximately $121.1 million through the issuance of 21.7 million American Depository Shares. The company intends to use the funds for the ongoing launch of Vascepa and also for advancing the REDUCE-IT study.
We note that Vascepa, the only marketed product of the company, is approved in the U.S. as an adjunct to diet for reducing triglyceride levels in adults suffering from severe hypertriglyceridemia. Amarin started marketing the drug in the U.S. in Jan 2013. The company sometimes refers to this as the MARINE indication. Amarin reported $5.5 million sales of Vascepa in the second quarter of 2013.
The company is also seeking to get Vascepa approved for the treatment of adults with high triglyceride levels (≥200 mg/dL and <500 mg/dL), who are receiving statin therapy for elevated LDL-C (low-density lipoprotein cholesterol) levels. Amarin refers to this as the ANCHOR indication. In Apr 2013, the U.S. Food and Drug Administration accepted the supplemental New Drug Application (sNDA) for the ANCHOR indication. A response from the FDA should be out by Dec 20, 2013.
Amarin carries a Zacks Rank #3 (Hold). Companies that currently look well-positioned include Actelion Ltd. (ALIOF) with a Zacks Rank #1 (Strong Buy), and Jazz Pharmaceuticals Public Limited Company (JAZZ) and Cempra, Inc. (CEMP) with a Zacks Rank #2 (Buy).