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February 26, 2015

Amarin and Eddingpharm partner to develop and market Vascepa in China

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.

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.

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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."

"Our agreement with Eddingpharm reflects the culmination of a competitive process and represents a significant step toward 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.

Related Companies

Free Whitepaper
img

What is the impact of China’s Zero-COVID lockdowns on economic activity, consumer goods and the foodservice industry?

While wanting to protect the country from being overwhelmed by Omicron, China’s adherence to a Zero-COVID policy is resulting in a significant economic downturn. COVID outbreaks in Shanghai, Beijing and many other Chinese cities will impact 2022’s economic growth as consumers and businesses experience rolling lockdowns, leading to a slowdown in domestic and international supply chains. China’s Zero-COVID policy is having a demonstrable impact on consumer-facing industries. Access GlobalData’s new whitepaper, China in 2022: the impact of China’s Zero-COVID lockdowns on economic activity, consumer goods and the foodservice industry, to examine the current situation in Shanghai and other cities in China, to better understand the worst-affected industry sectors, foodservice in particular, and to explore potential growth opportunities as China recovers. The white paper covers:
  • Which multinational companies have been affected?
  • What is the effect of lockdowns on foodservice?
  • What is the effect of lockdowns on Chinese ports?
  • Spotlight on Shanghai: what is the situation there?
  • How have Chinese consumers reacted?
  • How might the Chinese government react?
  • What are the potential growth opportunities?
by GlobalData
Enter your details here to receive your free Whitepaper.

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