"We are pleased that the ANCHOR study has been able to complete the patient randomization process before the end of 2010," said Joseph S. Zakrzewski, Executive Chairman and Chief Executive Officer of Amarin. "Following the very positive results of the recently reported MARINE study in which AMR101 demonstrated that it reduced triglyceride levels without increasing LDL-C in patients with very high triglycerides (>500 mg/dL), the ANCHOR study evaluates AMR101 in a different and larger patient population. AMR101 is designed to be first-in-class for this indication. In the U.S. alone, there are 36 million patients with triglyceride levels in the range being studied in the ANCHOR trial."
On November 29, 2010, the Company reported positive top-line data for its pivotal Phase 3 MARINE study. In that study, AMR101 was shown to effectively lower triglyceride levels in patients with very high triglycerides (>500mg/dl) without increasing LDL-C. AMR101 is the first omega-3 based product outside of Japan to demonstrate statistically significant triglyceride reduction without an increase in LDL-C. The Company believes that this is because AMR101, like a similar product in Japan, consists of >96% ethyl-EPA (ethyl icosapentate) and no DHA (Docosahexaenoic acid). DHA has been linked to increases in LDL-C. The MARINE study results also included favorable findings with respect to significant reductions in total cholesterol, non-HDL-C, Apo B, and Lp-PLA2 levels together with a safety profile for AMR101 that appears to be both comparable to placebo and more favorable compared to other triglyceride lowering therapies. The MARINE study was conducted in a population representative of millions of people with very high triglyceride levels, including more than 3.8 million in the U.S. Amarin believes that AMR101 is positioned to be best-in-class for this indication.
SOURCE Amarin Corporation plc