Amarin Corporation plc
- Company Name
- Amarin Corporation plc
- Stock Symbol
- Class Period
- September 24, 2018 to November 9, 2018
- Motion Deadline
- April 23, 2019
- District of New Jersey
The complaint charges Amarin and certain of its officers with violations of the Securities Exchange Act of 1934. Amarin is a pharmaceutical company focused on developing therapeutics to improve cardiovascular health. Amarin’s product development program leverages its experience in lipid science and the potential therapeutic benefits of polyunsaturated fatty acids.
Vascepa® (icosapent ethyl) is Amarin's first FDA-approved drug for the treatment of cardiovascular disease. The REDUCE-IT cardiovascular outcomes study commenced in 2011 to evaluate the effect of Vascepa, or any therapy, in adult patients with LDL-cholesterol (“LDL-C”) controlled to between 41-100 mg/dl by statin therapy and various cardiovascular risk factors, including persistent elevated triglycerides. The REDUCE-IT study tested whether additional cardiovascular risk reduction beyond LDL-C controlled with statin therapy could be achieved in high-risk patients with the putative cardioprotective effects of 4 grams/day of Vascepa.
The complaint alleges that during the Class Period, defendants made false and misleading statements about the REDUCE-IT trial for Vascepa, including that the top-line results from the trial were not as positive as the Company had represented and the placebo given to patients in the control arm of the REDUCE-IT trial may have increased the incidence of cardiovascular events in those patients. As a result of defendants’ misrepresentations regarding the REDUCE-IT trial and Vascepa, Amarin securities traded at artificially inflated prices during the Class Period, with its stock price reaching a high of more than $23 per share.
Then on November 10, 2018, the scientists that conducted the REDUCE-IT trial presented the full results at the Scientific Session of the American Heart Association. In the presentation, they disclosed for the first time that “bad” LDL-C levels had risen 3% in the Vascepa patients and 10% in the placebo patients. This raised concerns that the mineral oil placebos might have interfered with the background regimen of cholesterol-lowering statins that all the patients in the study were taking. The 10% increase in LDL-C might have led to more adverse cardiovascular events among placebo patients. On the release of the full study results, the price of Amarin securities fell 27% in two trading sessions to close at $15.38 per share.