In a update to investors ahead of next weeks presentation at JPM17, Amarin (NASDAQ:AMRN) says 2016 revenue should be slightly above $125M (+54%), expected to grow as much as 32% this year to as high as $165M. Vascepa prescriptions rose more than 50% and represented more than 20% of the prescription omega-3 market.
The large-scale cardiovascular outcomes trial, REDUCE-IT, has one more year to run. Top-line data are expected in 2018.
Amarin (NASDAQ:AMRN) eases 6% premarket on average volume in response to its announcement that its cardiovascular (CV) outcomes study, REDUCE-IT, evaluating whether Vascepa (icosapent ethyl) reduces CV events in patients with elevated triglyceride levels and other CV risk factors despite being on stabilized statin therapy, will continue as planned. The decision was based on the recommendation of the independent Data Monitoring Committee after its review of the first pre-specified interim efficacy analysis.
Per the study protocol, the first interim analysis was performed after 60% of the target 1,612 aggregate primary CV events occurred in the 8,175-subject study. The second interim analysis will be done when 80% of the target aggregate CV events have occurred, projected to happen in mid-2017. The database will be locked and the study stopped at this point or at the final analysis, projected to be at the end of 2017.
Vascepa (AMR101) consists of one gram of the omega-3 acid know as EPA in ethyl-ester form. The company says it is not fish oil, but derived from fish. It is currently approved in the U.S. as an adjunct to diet to reduce triglyceride levels in adults with hypertriglyceridemia (>= 500 mb/dL).
Shares have quadrupled since bottoming at $0.78 on November 11, 2014.
Amarin (NASDAQ:AMRN) is down 10% after hours on robust volume in response to its announcement that it has initiated a public offering of American Depositary Shares pursuant to a shelf registration. Price, volume and terms have yet to be released.
Update: The company priced its offering of 21M ADSs at $2.85. Closing date is August 16.