Amarin Reaches Target Enrollment in Cardiovascular Outcomes Study of Vascepa(R) in Patients With Elevated Triglycerides Despite Statin Therapy

BEDMINSTER, NJ and DUBLIN, IRELAND--(Marketwired - March 31, 2016) - Amarin Corporation plc (NASDAQ: AMRN) today announced that target patient enrollment has been reached in its REDUCE-IT cardiovascular outcomes trial of Vascepa (icosapent ethyl). Amarin also announced that the onset of approximately 60% of the target aggregate number of primary cardiovascular events within the REDUCE-IT study has triggered preparation for a pre-specified interim efficacy and safety analysis by the independent Data Monitoring Committee (DMC). Amarin currently expects the independent interim analysis to be conducted in approximately six months.

Enrollment Target Achieved

The REDUCE-IT study was designed to enroll approximately 8,000 patients. This enrollment target has been reached and Amarin is winding down patient enrollment on a country by country basis. Since the study commenced in 2011, over 20,000 patient years of study have been accumulated in REDUCE-IT. 

"We are pleased to announce that we have reached the target enrollment in REDUCE-IT, the first multinational cardiovascular outcomes study prospectively designed to investigate whether there is a meaningful reduction in the occurrence of major cardiovascular events when EPA is added to statin therapy in high-risk patients with elevated triglycerides," said Steven Ketchum, Ph.D., president of research and development and chief scientific officer at Amarin. "Vascepa demonstrated a broad spectrum of favorable effects on lipid, lipoprotein, and inflammatory biomarkers compared to placebo in Phase 3 studies focused on patients with high triglyceride levels after statin therapy and on patients with very high triglyceride levels. Through long-term study of patients treated with Vascepa in REDUCE-IT, we aim to provide a robust dataset to determine whether the effects of highly-pure EPA omega-3 prescription drug therapy will lower the risk of cardiovascular events in the high-risk patient population studied."

Interim Analysis Expected in Approximately Six Months

The REDUCE-IT study's event rate continues to track to prior estimates. A pre-specified interim efficacy and safety analysis was designed to be conducted upon achieving approximately 60% of the 1,612 aggregate primary cardiovascular events within the study. REDUCE-IT patients are in the process of completing a study visit over the next several months, after which additional time is required by the contract research organizations to finish collecting and preparing data for transfer to and analysis by the DMC. As is typical for large-scale, multi-national studies, regardless of the strength of the study results this data preparation and transfer process is expected to take several months. The DMC's analysis is anticipated to occur in approximately six months.