Inventiva and Sino Biopharm announce licensing and collaboration agreement to develop and commercialize lanifibranor in Greater China
Daix (France), Long Island City (New York, United States), Beijing/Hong Kong (China), 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, 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”).
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.
About Inventiva
Inventiva is a clinical-stage biopharmaceutical company focused on the research and development of oral small molecule therapies for the treatment of patients with NASH, MPS and other diseases with significant unmet medical needs. The Company benefits from a strong expertise and experience in the domain of compounds targeting nuclear receptors, transcription factors and epigenetic modulation. Inventiva’s lead product candidate, lanifibranor, is currently in a pivotal Phase III clinical trial, NATiV3, for the treatment of adult patients with NASH, a common and progressive chronic liver disease for which there are currently no approved therapies.
The Company has established a strategic collaboration with AbbVie in the area of autoimmune diseases that resulted in the discovery of the drug candidate cedirogant (ABBV-157), an oral RORγ inverse agonist which is being evaluated in a Phase IIb clinical trial, led by AbbVie, in adult patients with moderate to severe chronic plaque psoriasis. Inventiva’s pipeline also includes odiparcil, a drug candidate for the treatment of adult mucopolysaccharidoses (MPS) VI patients. As part of Inventiva’s decision to focus clinical efforts on the development of lanifibranor, it suspended its clinical efforts relating to odiparcil and is reviewing available options with respect to its potential further development. Inventiva is in the process of selecting an oncology development candidate for its Hippo signalling pathway program.
The Company has a scientific team of approximately 80 people with deep expertise in the fields of biology, medicinal and computational chemistry, pharmacokinetics and pharmacology, and clinical development. It owns an extensive library of approximately 240,000 pharmacologically relevant molecules, approximately 60% of which are proprietary, as well as a wholly-owned research and development facility.
Inventiva is a public company listed on compartment C of the regulated market of Euronext Paris (ticker: IVA - ISIN: FR0013233012) and on the Nasdaq Global Market in the United States (ticker: IVA). www.inventivapharma.com.
About Sino Biopharm
Sino Biopharm is a leading, innovative R&D-driven pharmaceutical conglomerate in China. Its business encompasses a fully-integrated chain which covers an array of R&D platforms, a line-up of intelligent production and a strong sales system. Sino Biopharm’s products have gained a competitive foothold in various therapeutic categories with promising potential, comprising a variety of biopharmaceutical and chemical medicines for oncology, surgery/orthopedics, liver disease, and respiratory system. The collaboration with Inventiva is managed by invoX Pharma Limited (“invoX”), a wholly owned subsidiary of Sino Biopharm, headquarter in the United Kingdom. invoX is Sino Biopharm’s international expansion platform, focusing on R&D and business development activities outside of China.
For further information about Sino Biopharm, please visit: http://www.sinobiopharm.com/.
About lanifibranor
Lanifibranor, Inventiva’s lead product candidate, is an orally-available small molecule that acts to induce anti-fibrotic, anti-inflammatory and beneficial vascular and metabolic changes in the body by activating all three peroxisome proliferator-activated receptor (PPAR) isoforms, which are well-characterized nuclear receptor proteins that regulate gene expression. Lanifibranor is a PPAR agonist that is designed to target all three PPAR isoforms in a moderately potent manner, with a well-balanced activation of PPARα and PPARδ, and a partial activation of PPARγ. While there are other PPAR agonists that target only one or two PPAR isoforms for activation, lanifibranor is the most advanced pan-PPAR agonist in clinical development for the treatment of NASH. Inventiva believes that lanifibranor’s moderate and balanced pan-PPAR binding profile contributes to the favorable tolerability profile that has been observed in clinical trials and pre-clinical studies to date. The FDA has granted Breakthrough Therapy and Fast Track designation to lanifibranor for the treatment of NASH.
Source: www.globenewswire.com