Amarin Partner EddingPharm Receives Regulatory Approval for Vascepa (Icosapent Ethyl) in Mainland China - Seite 2

“We are glad to receive this regulatory approval of VASCEPA from the NMPA China, and we are looking forward to securing reimbursement for this important product for patients and to a future CVRR indication approval,” said Rebecca Xu, Vice President of Clinical Development, EDDING. “Prevention and treatment of cardiovascular disease (CVD) is one of the major initiatives promoted by Healthy China 2030. However, few new CVD medications other than statins were launched in the market during the past several decades. In November 2020, EDDING announced the positive, statistically significant top-line results of the Phase 3 clinical trial conducted in Mainland China in severe hypertriglyceridemia patients. We will continue working with Amarin to bring this innovative drug into China to benefit Chinese patients.”

Under the partnership agreement, EDDING is responsible for development and commercialization activities in the China territory and associated expenses. Amarin provides development assistance and is responsible for supplying finished bulk product. Following the NMPA approval for this indication, Amarin is now entitled to receive a regulatory milestone payment of $5 million. EDDING will also pay Amarin tiered double-digit percentage royalties on net sales of VASCEPA in the territory. Amarin will supply product to EDDING under negotiated supply terms.

About Amarin

Amarin is an innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. We are committed to increasing the scientific understanding of the cardiovascular risk that persists beyond traditional therapies and advancing the treatment of that risk for patients worldwide. Amarin has offices in Bridgewater, New Jersey in the United States, Dublin in Ireland, Zug in Switzerland, and other countries in Europe as well as commercial partners and suppliers around the world.

About VASCEPA/VAZKEPA (icosapent ethyl) Capsules

VASCEPA capsules are the first prescription treatment approved by the U.S. Food and Drug Administration (FDA) comprised solely of the active ingredient, icosapent ethyl, a unique form of eicosapentaenoic acid. VASCEPA was launched in the United States in January 2020 as the first and only drug approved by the U.S. FDA for treatment of the studied high-risk patients with persistent cardiovascular risk after statin therapy. VASCEPA was initially launched in the United States in 2013 based on the drug’s initial FDA approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been prescribed more than 20 million times. VASCEPA is covered by most major medical insurance plans. In addition to the United States, icosapent ethyl is approved and sold in Canada, Lebanon, and the United Arab Emirates. In Europe, in March 2021 marketing authorization was granted to icosapent ethyl in the European Union for the reduction of risk of cardiovascular events in patients at high cardiovascular risk, under the brand name VAZKEPA. VAZKEPA is being commercialized in multiple European countries, including England, Wales, Sweden and Finland.