Come Monday, and Amarin Corp. plc (AMRN), a clinical stage biopharmaceutical company, faces a make-or-break day when it reports top-line results of its only medicine in late-stage trials - the fat-lowering AMR101.
AMR101, an omega-3 fatty acid-based drug, is a semi-synthetic, ultra pure (>96%) ethyl ester of eicosapentaenoic acid (ethyl-EPA). AMR101 is studied under two phase III studies - MARINE and ANCHOR, under Special Protocol Assessment agreements with the FDA.
Before the bell Monday, Amarin will be reporting the top-line results of phase III MARINE study of AMR101, which is being developed for lowering triglycerides in patients with very high triglycerides (>500mg/dl) and in patients with mixed dyslipidemia who are taking statins.
The MARINE trial, which enrolled 229 patients with fasting triglyceride levels greater than or equal to 500 mg/dl, is a 12-week pivotal study to evaluate the efficacy and safety of 2 grams and 4 grams of AMR101.
The ANCHOR study is a 650-patient, 12-week study to evaluate the efficacy and safety of 2 grams and 4 grams of AMR101 in patients with high triglyceride levels of 200-500 mg/dl who are on statin therapy (mixed dyslipidemia). The top-line results from the ANCHOR study are expected in mid-2011.
The only one omega-3 fatty acid-based drug approved in the U.S. for treatment of patients with very high triglycerides (>500 mg/dl) is GlaxoSmithKline plc's (GSK) Lovaza. The same product is marketed in Europe as Omacor. In 2009, Lovaza logged in sales of £450 million ($702 million), up 31% over 2008. In the nine months ended September 30, 2010 Lovaza sales totaled $590 million.
According to Amarin, its drug candidate AMR101 is different from GlaxoSmithKline's Lovaza in that Lovaza contains ethyl esters of EPA and DHA while AMR101 contains ethyl ester of only EPA. DHA is known to elevate LDL cholesterol (bad cholesterol) levels. Therefore, AMR101, which is devoid of DHA, may not have the LDL effect. The daily dose of Lovaza is 4 grams (or 4 capsules) per day for patients with severe elevations of triglycerides of 500 mg/dl or above, while the daily dose of AMR101 is likely to be only half that of Lovaza.
In Amarin's pipeline, AMR101 is the only drug in late-stage testing. In April 2007, the company's Huntington's disease drug candidate Miraxion (eicosapentaenoic acid) failed to meet both primary and secondary endpoints in two phase III trials, and since then the company's share price has lost 90% of its value.
In 2009, Dublin-based Amarin's net loss widened to $59.3 million or $1.40 per share from $20 million or $0.91 per share in 2008. The last time the company reported revenue was in 2006 and it was $500,000 for that year.
Amarin has a lot riding on AMR101. Will the trial results fizzle or sizzle? Stay tuned...
For comments and feedback: editorial@rttnews.com