On September 21, 2022 Inventiva (Euronext Paris and Nasdaq: IVA), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (NASH) and other diseases with significant unmet medical needs, and Chia Tai-Tianqing Pharmaceutical Group Co., Ltd ("CTTQ"), a subsidiary of Sino Biopharm, reported that they have entered into a licensing and collaboration agreement (the "Agreement") to develop and commercialize lanifibranor, Inventiva’s proprietary compound, for the treatment of non-alcoholic steatohepatitis ("NASH") and potentially other metabolic diseases in mainland China, Hong Kong, Macau and Taiwan ("Greater China") (Press release, Inventiva Pharma, SEP 21, 2022, View Source [SID1234621346]).
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Frederic Cren, CEO and cofounder of Inventiva, stated: "This agreement with Sino Biopharm represents an important milestone not only to support and accelerate the development of lanifibranor, but also to potentially develop and commercialize lanifibranor in Greater China, a region which has a similar prevalence of NASH to the U.S. and a large number of untreated patients at risk of progressing to cirrhosis. Moreover, this agreement could make a significant contribution to the reinforcement of our cash position. We are particularly proud of partnering with Sino Biopharm, a company with a strong presence in the hepatology field and a clear motivation and strategy to make lanifibranor a potential treatment option for patients with NASH in Greater China."
Theresa Tse, Chairwoman, Sino Biopharm: "This agreement is further evidence of Sino Biopharm’s commitment to seeking innovation, in one of our core therapeutics areas, liver disease. We have been at the forefront in helping China eliminate hepatitis B for over a decade, and today, NASH without any approved treatments, is the fastest growing cause of liver transplants and liver cancer, so we are delighted to enter into this agreement with Inventiva, which is a great opportunity to bring a promising and convenient treatment of NASH to China."
Sean Chen, Chief Strategy Officer, Sino Biopharm: "Sino Biopharm ranks top in China on liver disease drug sales and we believe this collaboration on lanifibranor, the potential best-in-class pan-PPAR agonist for the treatment of NASH, will further enrich our innovative pipeline on liver disease and strengthen our leadership in this therapeutic area. Our team is looking forward to partnering with Inventiva to accelerate the development of Lanifibranor in China and to satisfy an unmet clinical need in the quickest possible timeframe."
In exchange for receiving an exclusive license to develop, import, manufacture, commercialize and market lanifibranor in Greater China, CTTQ will pay Inventiva an upfront payment of $12 million and $5 million are also expected in the short-term if certain clinical milestones are met. Under the terms of the Agreement, Inventiva has the potential to receive up to $290 million of clinical, regulatory and commercial milestone payments. In addition, subject to regulatory approval, Inventiva will receive tiered royalties from high single-digit to mid-teen double digits of net sales made by Sino Biopharm in Greater China during the first three years of commercialization and from low to mid-teen double digits starting from year four. Depending on multiple factors, including Chinese regulatory authority feedback, CTTQ will either join the ongoing NATiV3 Phase III clinical trial of lanifibranor in NASH or run an independent study. CTTQ will bear all costs associated with the trials conducted in Greater China.