Amarin's New Drug Application Set To Be Submitted This Quarter

By Staff and Wire Reports

Monday, 01 August 2011 07:19

Amarin Corporation plc (Nasdaq:AMRN), the clinical-stage biopharmaceutical company with expertise in lipid science focused on the treatment of cardiovascular disease, announced today the successful completion of all remaining studies required for the Company's planned new drug application for AMR101 for the treatment of patients with very high triglycerides.

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Completion of these studies is a key step in the Company's plans to submit an NDA for AMR101 by the end of September. AMRN previously announced that it achieved all primary endpoints in its two pivotal Phase 3 clinical trials, both of which have SPA agreements with the FDA (MARINE and ANCHOR), and completed all pre-clinical studies. The Company has now successfully completed all clinical pharmacology studies needed to characterize AMR101. Furthermore, the Company believes that it has met all of the requirements for the submission of a complete package of studies for the NDA for the treatment of patients with very high triglyceride levels. All findings from these clinical pharmacology studies were consistent with the Company's expectations with no AMR101-related inhibition in metabolism of the drugs studied. These results reinforce the Company's perspective from its Phase 3 clinical trials that the overall safety profile of AMR101 is comparable to placebo.

"The completion of these final studies clears the way for our NDA submission by the end of next month," said Joseph Zakrzewski, Amarin's Chairman and CEO. "The Amarin team is now focused on completing the final work for the AMR101 NDA package, and we are looking forward to moving into the regulatory review process."

AMR101 is a prescription-grade omega-3 fatty acid, comprising not less than 96% ultra pure EPA (icosapent ethyl), that Amarin is developing as a potentially best-in-class prescription medicine for the treatment of patients with very high triglyceride levels (>=500 mg/dL) and as a potentially first-in-class therapy for patients with high triglyceride levels (>200 and <500mg/dL) who are also on statin therapy for elevated LDL-cholesterol levels (which we refer to as mixed dyslipidemia). Significant scientific and clinical evidence support the efficacy and safety of ethyl-EPA in reducing triglyceride levels and other important lipid and inflammation biomarkers, including Apo-B, non-HDL-C, Total-Cholesterol, VLDL-C, Lp-PLA2, and hs-CRP without increasing LDL-C. AMR101 intentionally excludes DHA, which is believed to result in increases in LDL-C. AMR101 demonstrated a safety profile comparable to placebo in two complete Phase 3 clinical trials.

Amarin also has next-generation lipid candidates under evaluation for preclinical development.

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