Amarin Corp Plc (AMRN)

[Sam81]

SunTrust Pharmaceuticals – Valuation & Catalyst Calendars for Week Ending 9/30/2016

AMRN (Buy; $6 PT) – On September 12, 2016, the independent data monitoring committee (DMC) for its Vascepa’s REDUCE-IT outcomes study completed its review of the first pre-specified interim efficacy. We expect AMRN to publish the REDUCE-IT trial design in a research publication such as New England Journal of Medicine. AMRN expects REDUCE-IT to attain ~80% of total target events in the first half of 2017, with the second pre specified interim efficacy analysis anticipated by mid- 2017. The REDUCE-IT trial is expected to conclude and have final data published & potential sNDA submission in 2018.
The Vascepa clinical trial application that was filed with the China State Food and Drug Administration was accepted, with AMRN expecting the sFDA to determine clinical trial requirements to support approval. The 5-year Vascepa co-promotion arrangement with Kowa Pharma (private) is scheduled to end in 2018.