Amarin's AMR101 Phase 3 ANCHOR Trial Meets All Primary And Secondary Endpoints With Statistically Significant Reductions In Triglycerides At Both 4 Gram And 2 Gram Doses And Statistically Significant Decrease In LDL-C
Principal Investigator and Company Very Encouraged by Results
"The design and execution of the ANCHOR trial were robust and the trial results were very clearly positive," said Christie M. Ballantyne, M.D., Methodist DeBakey Heart and Vascular Center, Houston, and principal investigator of the ANCHOR trial. "I am very impressed with the performance of AMR101. In particular, whereas current triglyceride-lowering drugs may raise LDL-C and causes patient treatment concerns, AMR101 demonstrated a decrease in LDL-C beyond the decrease created by statin therapy. Furthermore, it is very encouraging for patient care that AMR101 caused reductions in significant markers of cardiovascular risk such as Apo B and non-HDL-C. The greater triglyceride reduction in patients with higher potency statin regimens is also very encouraging."
Commenting on the ANCHOR trial results, Joseph S. Zakrzewski, Chief Executive Officer and Executive Chairman of Amarin, stated, "We are delighted by the results of the ANCHOR trial. In November we announced MARINE trial results which position AMR101 to be best-in-class for treating patients with very high triglycerides. The ANCHOR trial results are even more remarkable than the broadly positive MARINE trial results. We believe these results clearly differentiate AMR101 from other triglyceride lowering therapies and position AMR101 to be both first-in-class and best overall therapy for treating the high triglyceride population. We thank the ANCHOR team, including our investigators, for their many contributions to this outstanding study design and execution."
Large Market PotentialIn the U.S. alone, approximately 40 million people have triglyceride levels above 200 mg/dL. The majority of these patients have high triglyceride levels of ≥200 and <500mg/dL as studied in the ANCHOR trial with approximately 4 million of these people having very triglyceride levels >500 mg/dL as studied in the MARINE trial. Currently, no omega-3 based product is approved for the indication studied in the ANCHOR trial. In the seven largest pharmaceutical markets (U.S., Japan and five largest European markets), it is estimated that over 100 million people have mixed dyslipidemia. Conference Call and Webcast Information Amarin will host a conference call at 8:00 a.m. EDT today, April 18, 2011, to comment on the ANCHOR results and the Company's current operating and strategic objectives. To participate in the call, please dial (877) 407-0778 within the U.S. or (201) 689-8565 from outside the U.S. A replay of the call will be made available for a period of two weeks following the conference call. To hear a replay of the call dial (877) 660-6853 (inside the U.S.) or (201) 612-7415 (outside the U.S.). A replay of the call will also be available via the Company's Web site shortly after the call. For both dial-in numbers please use account number 286 and conference ID 371147. The conference call can also be heard live via the investor relations section of the Company's Web site at www.amarincorp.com. About ANCHOR The ANCHOR trial, a multi-center, placebo-controlled, randomized, double-blind, 12-week pivotal study to evaluate the efficacy and safety of 2 grams and 4 grams of AMR101, enrolled 702 patients with fasting triglyceride levels from 200 mg/dL to less than 500 mg/dL who were also on background statin therapy (treated to the National Cholesterol Education Program Adult Treatment Panel III (NCEP III) target goal of 100 mg/dL). Patients in this trial were characterized as having high triglyceride levels according to the NCEP III treatment guidelines. The secondary endpoints in the ANCHOR trial include the difference in LDL-cholesterol levels between AMR101-treated and placebo-treated groups to demonstrate that the addition of AMR101 to statin therapy does not increase LDL-cholesterol (LDL-C or "bad cholesterol") in this population. Both treatment groups received statin therapy for the treatment of high LDL-cholesterol. Secondary measures in the ANCHOR trial were the difference in other lipid and biomarker levels between AMR101 and placebo treatment groups.
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