On Tuesday morning, Amarin Corporation plc (Nasdaq:AMRN), announced that data from their MARINE trial, a pivotal Phase 3 study investigating AMR101 as a treatment for very high triglycerides (≥500 mg/dL), will be presented at the National Lipid Association (NLA) 2011 Annual Scientific Sessions on May 19-22, 2011.
According to a press release from the company, the MARINE trial results will be presented in an abstract titled "AMR101, a Pure-EPA Omega-3 Fatty Acid, Lowers Triglycerides in Patients With Very High Triglycerides Without Raising LDL-C: the MARINE Study" by Harold Bays, M.D., Medical Director, Louisville Metabolic and Atherosclerosis Research Center, and principal investigator of the study. As reported in November 2010, the MARINE study met its primary endpoint of percent change in triglyceride (TG) levels from baseline to week 12, for both the 4 gram and 2 gram dose groups of AMR101.Additionally, the MARINE study demonstrated no statistically significant increase in LDL cholesterol and a safety profile similar to placebo.
Patrick Crutcher of BioMedReports, who closely covers the stock and recently spoke to our premium subscribers about the trials during a web conference, has the following thoughts on the company's still highly anticipated ANCHOR study:
"Their lead product, AMR-101, has already posted successful results in their MARINE study, and we believe that they have a high likelihood of showing the same in the ANCHOR study. Amarin expects to announce the ANCHOR results sometime in Q2. Based on the completed randomization in December, 12-week endpoints, additional administrative work and data analysis, we suspect the results could be available sometime in April.
Remember, Amarin is developing AMR101(ethyl icosapentate), which is an ultra-pure (>96% ethyl-EPA), prescription-grade omega-3 fatty acid compound for the treatment of patients with very high triglyceride(TG) levels(MARINE, 500 ≤ TGL ≤ 2000 mg/dL) and the other for the treatment of patients with high triglycerides with mixed dyslipidemia(ANCHOR , 200 ≤ TGL ≤ 500 mg/dL). The MARINE indication covers more than 3.5-4.0 million patients, while the ANCHOR indication covers well over 30-35 million patients in the US. Both Phase 3 trials are being conducted under Special Protocol Assessment (SPA) agreements with the FDA. Back in November, Amarin demonstrated very positive results in the MARINE study, demonstrating a 33%(4g, high dose) and 20%(2g, low dose) reduction in TG levels, without an effect on cholesterol(something Lovaza actually increases).
We think that there is significant rationale to believe that the ANCHOR results will yield positive results. A recent 191-patient study for mixed dyslipidemia patients(Nomura et al, 2009) demonstrated that “EPA(1.8g) alone or combined therapy significantly(p<0.05) lowered TG levels compared with those observed with pitavastatin alone." Here EPA was Epadel, a currently approved ethyl-EPA prescription product in Japan. These are significant results for several reasons. First, it reaffirms our belief that AMR-101 at 2g and 4g has very high chances of showing positive results in this patient population. Now if you look at the MARINE study, they saw that those on background statin therapy had much greater median reductions in TG levels(statistically significant), than those not on statin therapy. Part of the inclusion criteria for the ANCHOR study was a stable dose of statins. This synergistic effect could play in important role in the ANCHOR results and later potential studies for the additional indication as a combination therapy with statins. "
If you did not hear Patrick's coverage on the stock during the recent conference call in late March, it is available in audio format below and for download here: http://www.box.net/shared/np8f78byqb
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