SunTrusy Contd (Sorry not able to attach the research)
statins. REDUCE-IT reached target enrollment of approximately 8,000 patients and the onset of
approximately 60% of the target aggregate number of primary cardiovascular events within the study
has triggered preparation for a protocol pre-specified interim efficacy analysis by the independent Data
Monitoring Committee (DMC) expected to be conducted in September or October 2016. The pending
interim analysis in late 3Q16/early 4Q16 represents the first review of unblinded efficacy data by the
DMC. Amarin remains blinded to the interim and ongoing results of the REDUCE-IT study until after
the study is ready to be stopped either at the interim analysis or at the final analysis. The REDUCE-IT
trial design is modeled after nine previous outcomes trials for statins. We expect Amarin to showcase
its REDUCE-IT trial design in a peer-reviewed scientific journal over the next few months (https://
clinicaltrials.gov/ct2/show/NCT01492361). Given the nature of outcomes studies and the design of
REDUCE-IT, Amarin expects the DMC recommends that REDUCE-IT continue until attainment of
100% of the target 1,612 primary events, which is estimated to occur in 2017, yielding publication of
results in 2018. The REDUCE-IT trial is expected to conclude and have final data published & potential
sNDA submission in 2018. Amarin believes a successful REDUCE-IT result would enable Vascepa
to capture a larger share of the 25M annual prescriptions written for other triglyceride-lowering nonstatin
agents such as fibrates & prescription niacin.
