By Patrick Crutcher
Amarin Corp. (NASDAQ:AMRN) has a potential blockbuster in the making with AMR101 and volume has really started to pick up. Many investors are getting in early on this clinical trials catalyst. Why? Because AMR101 has Lovaza-like potential with limited downside.
Amarin initiated two Phase 3 clinical trials to investigate the efficacy of AMR101 in reducing elevated triglyceride levels in two patient populations (the ANCHOR and MARINE trials). AMRN was able to complete enrollment in one of their Phase 3 trials (MARINE) in early August and the ANCHOR trial has more than 50% of patients enrolled out of the targeted 650. The MARINE study’s objective will be to determine the efficacy of AMR101 versus placebo in lowering triglyceride levels in patients with very high triglyceride levels (500 ≤ TGL ≤ 2000 mg/dL). The ANCHOR study (most important) is aimed at those with very high triglyceride levels (200 ≤ TGL ≤ 500 mg/dL). Top-line results for the MARINE study are now expected in late 2010 to early 2011, based on statements from Amarin and the general length of the study.
AMR101 (ethyl icosapentate) is a purified, prescription-grade omega-3 fatty acid compound that is presently being investigated in two Phase 3 clinical trials, one for the treatment of patients with very high triglyceride levels and the other for the treatment of patients with high triglycerides with mixed dyslipidemia. Both Phase 3 trials are being conducted under Special Protocol Assessment (SPA) agreements with the FDA.
Investors should know that they did not conduct Phase 2 studies, since their research is based on over a decade of use in Japan and other previous studies by Amarin in central nervous system disorders. Numerous independent studies have demonstrated the safety and efficacy of ethyl-EPA in lowering plasma triglycerides in patients with high triglyceride levels of varying degrees of severity. In Japan, an ethyl-EPA prescription product has been approved for the treatment of hyperlipidemia and has been on the market for more than a decade. So safety concerns are minimal with years of research backing this product.
AMR101 has the potential to address a substantially larger patient population than Lovaza and they are taking aim at Lovaza’s indication. Lovaza is currently labeled to help patients with triglyceride levels greater than 500 mg/dL. AMR101 could potentially be used for those with triglycerides from 200 to 2000 mg/dL, which would be the broadest label for this indication. AMR101 has the potential to address over 100 million patients in the United States if approved and both studies show strong efficacy. AMR101 also does not have the fishy taste, smell or belching that are common for Lovaza. Lovaza had global sales of over $1 billion in 2009.
AMRN has the cash to fund them through the potential filing of an NDA for AMR101, but we shouldn’t assume they will do this alone. We find it hard to imagine that large pharma would allow such a small company to bring a potentially billion dollar product to market without being a part of the action. One might even imagine that GlaxoSmithKline (NYSE:GSK) (owns Lovaza) would be interested in order to push a better product. Lovaza is also facing generic competition. GlaxoSmithKline bought Lovaza-maker Reliant for $1.65B in 2007. Over the coming weeks, you can expect volume in AMRN to really pick up as analysts start to recognize the value. Be sure to keep an eye on this company.
Disclosure: Long AMRN