China’s National Medical Products Administration (NMPA) has granted regulatory approval to Amarin’s commercial partner EddingPharm (EDDING) for Vascepa (icosapent ethyl).
Vascepa has been approved as an adjunct to diet to cut the levels of triglyceride in adult patients suffering from severe hypertriglyceridemia (≥500mg/dL).
EDDING is now working towards securing National Reimbursement Drug Listing (NRDL) for Vascepa in China, with plans to launch it commercially by the end of this year.
The company also intends to accelerate the regulatory submission and review process for its use in cardiovascular risk reduction.
Amarin research and development president and chief scientific officer Dr Steven Ketchum said: “We congratulate our partner, EDDING, on the regulatory approval of Vascepa in Mainland China, as this marks an important step in the process of offering this novel treatment to patients across that country.”
According to the partnership agreement, EDDING assumes the responsibility for undertaking development and commercialisation activities within the Chinese territory, along with covering associated expenses.
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The agreement obligates Amarin to provide developmental support and supply the finished bulk product.
As a result of obtaining the NMPA approval, EDDING has to pay $5m as a regulatory milestone payment to Amarin.
Furthermore, Amarin will receive tiered double-digit percentage royalties on the net sales of Vascepa in the territory.
EDDING clinical development vice-president Rebecca Xu said: “In November 2020, EDDING announced the positive, statistically significant top-line results of the Phase III clinical trial conducted in Mainland China in severe hypertriglyceridemia patients.”