Amarin Corp Plc (AMRN)

[ziploc_1]

Bouf:The Chinese study seems more like Marine than like R-IT...nevertheless it's a foot in the door to eventual recognition of Vascepa as an Rx to reduce CVE
"BEDMINSTER, N.J. and DUBLIN, Ireland, Jan. 17, 2018 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics, today announced that a clinical trial of Vascepa® (icosapent ethyl) capsules in a patient population with severe hypertriglyceridemia (TG ­≥500 mg/dL) has been commenced in Mainland China, or China, by Amarin's partner, Eddingpharm. Under the parties' February 2015 agreement, Eddingpharm is responsible for Vascepa development, regulatory activities, commercialization and associated costs, including managing and funding this pivotal registration study.

Similar to the MARINE trial conducted by Amarin, the trial being conducted by Eddingpharm in China is a multi-center, placebo-controlled, randomized, double-blind, 12-week study that is enrolling patients with severe hypertriglyceridemia, more commonly known as very high triglycerides, or VHTG. The study’s primary endpoint is the percentage change in triglyceride levels from baseline compared to placebo after 12 weeks of treatment. Eddingpharm anticipates that the study will be completed within the next two years. This clinical trial puts Vascepa on track to be the first ever pure prescription grade EPA based drug product in China. The parties believe the commercial opportunity in China is largely based on the prevalence of hypertriglyceridemia, which is estimated to affect around 17.7%1 of the adult Chinese population, about 185 million people."