AMR101 NDA submission 3Q
Triglyceride refers to a class of fat found in the bloodstream whose desired level is less than 150 mg/dL. Medical conditions such as diabetes, hypothyroidism, kidney disease, or liver disease and dietary causes like obesity and high intakes of fat, alcohol, and concentrated sweets result in elevated triglyceride levels. High triglyceride level is linked to increased risk of heart disease, heart attacks or strokes.
In the U.S. alone, about 40 million people are reportedly said to have triglyceride levels above 200 mg/dL. There is one FDA-approved omega-3 fatty acid based drug - Lovaza developed by GlaxoSmithKline plc (GSK), for treatment of patients with very high triglycerides (=500 mg/dl). But there are no omega-3 fatty acid based drugs approved for patients with high triglycerides (=200 and <500>
Working on the development of an omega-3 fatty acid based drug for the treatment of hypertriglyceridemia in patients with very high triglycerides (=500mg/dl) and for patients with high triglycerides (=200 and <500mg l)="" who="" also="" have="" mixed="" dyslipidemia,="" is="" clinical-stage="" biopharmaceutical="" company="" amarin="" corp.="">
The company's drug candidate is AMR101, a prescription-grade omega-3 fatty acid, comprising not less than 96% ultra pure icosapent ethyl (ethyl-EPA). AMR101 has successfully completed two pivotal phase III studies, namely MARINE and ANCHOR trials, under Special Protocol Assessment Agreements with the FDA.
The MARINE trial evaluated AMR101 in doses of 2 grams and 4 grams as a treatment for patients with very high triglyceride levels (=500 mg/dL). The primary endpoint in the trial was the percentage change in triglyceride level from baseline compared to placebo after 12 weeks of treatment.
Amarin reported positive, statistically significant top-line results from the MARINE study in November 2010. The new drug application for AMR101 for the treatment of patients with very high triglycerides (=500 mg/dl) is expected to be submitted this quarter (3Q).
If approved for the treatment of very high triglycerides, AMR101 will have to compete with GlaxoSmithkline's Lovaza. In 2010, Lovaza logged $822 million in sales, all of which were generated in the U.S. and Puerto Rico.
Lovaza was approved by the FDA in November 2004 and launched the following year in the U.S. The drug contains ethyl esters of omega-3 fatty acids (EPA and DHA) obtained from the oil of several fish sources.
According to Amarin, AMR101 is said to have significant advantages over Lovaza. AMR101 neither has a fishy taste and smell nor does it elevate LDL-C levels like Lovaza. Increasing LDL-C levels is an unwanted effect of triglyceride lowering therapy.
The ANCHOR trial evaluated 2 grams and 4 grams of AMR101 in patients with high triglycerides (=200 and <500mg l)="" who="" are="" on="" statin="" therapy.="" the="" primary="" endpoint="" in="" the="" trial="" is="" the="" percentage="" change="" in="" triglyceride="" level="" from="" baseline="" compared="" to="" placebo="" after="" 12="" weeks="" of="" treatment.="">
In April of this year, Amarin reported positive, statistically significant top-line results for the ANCHOR trial. Unlike the current triglyceride-lowering drugs, which raise LDL-C and cause patient treatment concerns, AMR101 also demonstrated a decrease in LDL-C in the ANCHOR trial.
There are no approved prescription omega-3 based drug in the United States for treating high triglyceride levels in statin-treated patients who have mixed dyslipidemia.
Mixed dyslipidemia refers to a condition in which patients have a combination of two or more lipid abnormalities including elevated triglycerides, low high-density lipoprotein cholesterol, and elevated low-density lipoprotein cholesterol and is believed to affect more than 34 million in the U.S. alone. The positive ANCHOR trial results positions AMR101 for a broader indication.
A quick look at the company's balance sheet...
As of March 31, 2011, Amarin had cash of $129.5 million and no long-term debt.
Being a clearly differentiated product for existing and new markets, Amarin sees a blockbuster worldwide sales potential for AMR101. The company is considering collaboration opportunities with larger pharmaceutical companies for the launch, marketing and sale of AMR101 and is in discussions with pharmaceutical companies regarding such a collaboration. During a recent investor presentation in June, Amarin noted that partner option could include sale of the company as well.
Will Amarin catch the eye of big pharma? Stay tuned...
Shares of Amarin have a 52-week price range of $2.24 to $19.87. The stock, which has gained over 37% year-to-date, closed Friday's trading at $11.24.
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