Amarin has signed an exclusive agreement with Eddingpharm to develop and commercialise Vascepa (icosapent ethyl) in mainland China, Hong Kong and the Macao Special Administrative Regions and Taiwan.
Also known as AMR101, Vascepa is a highly pure-EPA omega-3 prescription product in a 1g capsule.
The drug is currently under development by Amarin in the US, based on the Marine , ANCHOR and ongoing REDUCE-IT clinical trials.
Amarin president and CEO John Thero said: "Our agreement with Eddingpharm reflects the culmination of a competitive process and represents a significant step towards commercialising Vascepa in a major market outside the United States."
As part of the deal, Eddingpharm will be responsible for development and commercialisation activities in the territory and associated expenses, while Amarin will provide development assistance and be responsible for supplying finished and later bulk product.
The deal will include up-front and milestone payments of up to $169m to Amarin, including a non-refundable $15m up-front payment and development, regulatory and sales-based milestone payments of up to an additional $154m.
In addition, Amarin will receive tiered double-digit percentage royalties on net sales of Vascepa from Eddingpharm.
In the US, Vascepa is indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia.
Amarin noted that Vascepa also showed favourable effects on triglycerides and a spectrum of other lipid, lipoprotein and inflammatory biomarkers in the Phase III ANCHOR clinical trial of adult patients with high triglycerides despite statin therapy.
In order to evaluate the effectiveness in reducing the prevalence of first major cardiovascular events in a high-risk patient population, Vascepa is currently being studied in a multinational cardiovascular outcomes study, the REDUCE-IT study.
The independent Data Monitoring Committee (DMC) is expected to provide a protocol pre-specified interim data analysis of efficacy and safety results at 60% of targeted events in 2016. An estimated 8,000 patients are expected to be enrolled for REDUCE-IT by the end of this year.