Inventiva and Hepalys Pharma, Inc. announce exclusive licensing agreement to develop and commercialize lanifibranor in Japan and South Korea
2023-09-21
引进/卖出临床3期快速通道
Hepalys Pharma, Inc. is a new company created by Catalys Pacific and in which Inventiva has a 30% ownership position.
Under the exclusive licensing agreement, Inventiva will receive a $10 million upfront payment, and is eligible to receive up to $ 231 million in clinical, regulatory and commercial milestone payments in addition to tiered royalties from mid double digits to low twenties based on net sales of lanifibranor in Japan and South Korea.
Pending regulatory approvals, Hepalys Pharma, Inc. is expected to initiate Phase I PKPD studies in Japanese patients and healthy volunteers and will be responsible for funding all studies of lanifibranor necessary to file for a new drug application in Japan and South Korea.
In addition to the 30% of shares of Hepalys Pharma, Inc., Inventiva already owns, Inventiva has the option to acquire all outstanding shares of Hepalys Pharma, Inc., at a pre-agreed multiple of post-money valuation.
In the event Hepalys receives an offer to sell the license or rights related to lanifibranor, Inventiva has a right of first refusal.
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 Hepalys Pharma, Inc., a company incorporated in Japan and incubated by Catalys Pacific, have entered into an exclusive licensing agreement (the “Agreement”) to develop and commercialize Inventiva’s proprietary drug candidate lanifibranor for the treatment of non-alcoholic steatohepatitis (NASH) in Japan and South Korea.
Hepalys Pharma is a new company founded by Catalys Pacific, an investment firm specialized in creating and financing venture capital-backed biopharmaceutical companies to develop pharmaceutical products in Asia. Hepalys Pharma is backed by renowned investors including Catalys Pacific, Mitsubishi UFJ Capital, DBJ Capital, and MEDIPAL Innovation Fund.
In parallel of the incorporation of Hepalys Pharma, Inventiva has exercised its right to own 30% of the company.
Under the terms of this licensing agreement, Inventiva will receive a $10 million upfront payment from Hepalys Pharma and will be eligible to receive up to $231 million in milestone payments if certain clinical, regulatory and commercial conditions are met. Subject to regulatory approval, Inventiva has the right to receive tiered royalties from mid double digits to low twenties based on net sales of lanifibranor in Japan and South Korea.
In addition, under the terms of this agreement, Inventiva has the option to acquire the outstanding shares of Hepalys Pharma at a pre-agreed multiple of post-money valuation under certain conditions, and has a right of first refusal if Hepalys Pharma, Inc. receives an offer to sell the license and rights related to lanifibranor.
This agreement is expected to accelerate the time to market of lanifibranor in Japan and South Korea if regulatory approvals are obtained. Both countries are major markets, with up to 2.7%1 of and up to 5.2%2 of Japanese and South Koreans, respectively, suffering from NASH, including about 15% of South Korean patients with significant fibrosis. Hepalys Pharma, Inc. is expected to start the clinical development of lanifibranor by conducting two phase I studies in Japanese patients and healthy volunteers. It is anticipated that these studies would support, if positive, the initiation of a dedicated pivotal trial in Japanese and Korean patients with NASH, which is planned to start once the results of NATiV3, the pivotal phase III trial currently conducted by Inventiva, are available. Hepalys Pharma, Inc. will be responsible for conducting and financing all development trials in Japan and South Korea needed to file for a new drug application in these territories.
Frederic Cren, CEO and cofounder of Inventiva, stated: “We are thrilled to further expand our global reach to Japan and South Korea through this exclusive licensing agreement with Hepalys Pharma, Inc. We strongly believe that Hepalys Pharma, Inc. with its experienced team is the right partner to start and fund the clinical development of lanifibranor in Japan and South Korea. This agreement is a great opportunity for Inventiva to speed up the potential commercialization of its lead asset in these two major markets and diversify our milestones and royalties’ source of revenues if regulatory approvals are achieved. With the ongoing partnership in Greater China and this new agreement in Japan and Korea, Inventiva is eligible to receive up to an additional $519M of clinical, regulatory and commercial milestones.
BT Slingsby, MD, PhD, MPH, Representative Director of Hepalys Pharma, Inc., stated: “We are delighted to enter into a licensing agreement with Inventiva. We purposely founded Hepalys Pharma, Inc. to conduct the clinical development and potential commercialization of lanifibranor, a drug candidate for the potential treatment of NASH in Japan and Korea. We are confident that, if successful in our clinical programs and if required regulatory approvals are obtained, lanifibranor could potentially become an effective treatment for patients with NASH in Japan and South Korea based on the efficacy demonstrated so far on fibrosis and NASH resolution, and on the cardiometabolic components of the disease. We are looking forward to starting the clinical development program of lanifibranor in Japan and South Korea.”
About Hepalys Pharma, Inc.
Hepalys Pharma, Inc. is a private venture-backed biopharmaceutical company focused on the development of novel therapeutics for liver disease, led by a world-class team and a transpacific clinical advisory board, committed to develop and commercialize lanifibranor and potentially other compounds for patients in Asian countries. Hepalys is headquartered in Tokyo, Japan.
About Catalys Pacific
Catalys Pacific is a life sciences venture capital firm whose mission is to provide healthcare solutions for patients worldwide through the creation of, and investment in biotech companies. Catalys Pacific is led by a global team versed in working closely with its partners in academia, biotech, venture capital and the pharmaceutical industry worldwide with an emphasis in Japan. The firm maintains offices in Tokyo, Japan and in San Francisco, California.
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 only 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.
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 (also known as metabolic dysfunction-associated steatohepatitis (MASH)), mucopolysaccharidoses (“MPS”) and other diseases with significant unmet medical need. The Company benefits from a strong expertise and experience in the domain of compounds targeting nuclear receptors, transcription factors and epigenetic modulation. Inventiva is currently advancing one clinical candidate, has a pipeline of two preclinical programs and continues to explore other development opportunities to add to its pipeline.
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.
Inventiva’s pipeline also includes odiparcil, a drug candidate for the treatment of adult 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 also in the process of selecting an oncology development candidate for its Hippo signaling pathway program.
The Company has a scientific team of approximately 90 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 B 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
1Eguchi Y, Wong G, Lee EI, Akhtar O, Lopes R, Sumida Y. Epidemiology of non-alcoholic fatty liver disease and non-alcoholic steatohepatitis in Japan: A focused literature review. JGH Open. 2020 May 5;4(5):808-817.
2Park J, Lee EY, Li J, Jun MJ, Yoon E, Ahn SB, Liu C, Yang H, Rui F, Zou B, Henry L, Lee DH, Jun DW, Cheung RC, Nguyen MH. NASH/Liver Fibrosis Prevalence and Incidence of Nonliver Comorbidities among People with NAFLD and Incidence of NAFLD by Metabolic Comorbidities: Lessons from South Korea. Dig Dis. 2021;39(6):634-645.
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