Amarin Partner EddingPharm Gets China NMPA Approval for Vascepa for Cardiovascular Risk Reduction

Amarin partner EddingPharm gets China NMPA approval for Vascepa for cardiovascular risk reduction

Overview

Amarin Corporation plc, an innovative pharmaceutical company, announced that its commercial partner in Mainland China (China), EddingPharm (Edding), has received regulatory approval for Vascepa (icosapent ethyl) from China’s National Medical Products Administration (NMPA). NMPA granted approval for Vascepa to reduce the risk of cardiovascular events as an adjunct to statin therapy in adult patients with elevated and high triglycerides (=150mg/dL) and established cardiovascular disease or diabetes mellitus with =2 other cardiovascular disease risk factors, combined with hypertriglyceridemia.

Vascepa for NRDL Listing

• Following approval by NMPA, Edding is working to include Vascepa on the National Reimbursement Drug Listing (NRDL) and augment the ongoing commercial launch of Vascepa in China to include the CVRR indication. 
• The NRDL is updated annually and serves as the primary pathway for public reimbursement of pharmaceutical products in China, covering 98% of the Chinese population. 
• Inclusion on the NRDL provides full or partial reimbursement at the national level. 
• Products included in this listing can be prescribed from public hospitals in China.

Cardiovascular Disease in China

• According to a recent report on cardiovascular health and disease in China, cardiovascular disease (CVD) accounted for 44-47% of all death in urban and rural areas in China, meaning two out of every five deaths were due to CVD. 
• It is estimated that 330 million patients suffer from CVD in China, and that China has one of the highest CVD death rates in the world. 
• According to the World Heart Federation, cardiovascular events, such as ischemic heart disease and stroke, are projected to increase by 50 percent among the population in China between 2010 and 2030 (based on population aging and growth alone).

Statement from CSO: Amarin

• We congratulate our partner, Edding, on the regulatory approval of Vascepa for cardiovascular risk reduction in China, as this marks an important step in helping broaden access to this novel treatment for patients across that country,” said Steven Ketchum, Ph.D., president, research & development and chief scientific officer, Amarin. 
• This milestone is a major step forward to help ensure that the unique benefits of Vascepa are accessible to patients throughout the world. We look forward to Edding’s continued progress in introducing Vascepa to patients at-risk for a cardiovascular event across China.
• The approval of the CVRR indication will allow many patients with atherosclerotic disease (ASCVD) in China to benefit from this innovative drug,"" said Edding. 
• In the future, we will continue to expand the application of Vascepa in the management of cardiovascular diseases to meet the unmet clinical needs of more Chinese patients.

Approval Study Post Marketing

 As part of the approval, NMPA has requested that Edding conduct a post-approval study after the product is marketed to further verify the efficacy of the product to reduce the risk of cardiovascular events in Chinese patients and provide a post-approval study report to conduct a life-cycle benefit-risk assessment at the time of product renewal. Product renewal is required five years post the approval of the product.

Under The Agreement

• 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. 
• Based upon the NMPA approval for the CVRR indication, Amarin will earn a regulatory milestone payment in the amount of $15 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.

Vascepa Capsules

• Vascepa capsules are the first prescription treatment approved by the US 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 US 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, Spain, Sweden and Finland.

About Amarin

• Amarin is an innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. 
• The company 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.

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