Amarin Corporation Plc (Nasdaq: AMRN) shares surged 68.5% Monday morning, after it released late-study results yielding positive findings on its medicinal-grade fish oil drug.
The stock added on $6.00 to $14.77, trumping its 52-week peak of $9.66, set early in January. The clinical-stage pharmaceutical, with offices in Dublin and in Mystic, Conn., reported positive, statistically significant top-line results from its ANCHOR trial for the Company’s lead product candidate, AMR101. The Phase 3 trial met its primary and secondary efficacy endpoints for both the 4 gram and 2 gram daily doses.
The purpose of the ANCHOR trial was to demonstrate that AMR101 is effective in reducing triglyceride levels in patients with high triglycerides without increasing LDL-C (“bad cholesterol”) levels in patients on background statin therapy. In 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.
Amarin CEO Joseph S. Zakrzewski, said, “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.”
Amarin reported positive, statistically significant top-line results for both of its two pivotal Phase 3 clinical trials, the MARINE trial (investigation of AMR101 as a treatment for patients with very high triglycerides [>500 mg/dL]), as reported on November 29, 2010 and the ANCHOR trial. The Company is planning to file an non-disclosure agreement (NDA) for AMR101 before the end of Q3 2011.