Amarin Corporation plc AMRN announced that it has finished randomizing patients in the phase III REDUCE-IT study on a 1:1 basis between Vascepa (icosapent ethyl) and placebo.
REDUCE-IT will determine if Vascepa can reduce cardiovascular events in patients who have elevated triglyceride levels and other cardiovascular risk factors, despite stabilized statin therapy.
The primary endpoint includes the time of the first occurrence of the composite endpoint of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or hospitalization for unstable angina, while secondary endpoints comprise the time to event analyses of components of the primary endpoint.
Onset of the final primary cardiovascular event is expected during the second half of 2017. Results from the study are anticipated in 2018.
Amarin stated that it expects a protocol pre-specified interim efficacy and safety analysis from an independent Data Monitoring Committee (DMC) this month. A second interim efficacy and safety analysis is anticipated in mid 2017.
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We note that in the U.S., Vascepa is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. In the first half of 2016, the company generated Vascepa sales of $58.1 million, up 74.5%.
For the full year, the company expects sales to be in the range of $112–$125 million.
Amarin currently has a Zacks Rank #2 (Buy). Some favorably placed stocks in the health care sector include Anika Therapeutics Inc. ANIK, Pacira Pharmaceuticals, Inc. PCRX and ANI Pharmaceuticals, Inc. ANIP. All three stocks sport a Zacks Rank #1 (Strong Buy).
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