IVEVF - Inventiva and Hepalys Pharma Inc. announce exclusive licensing agreement to develop and commercialize lanifibranor in Japan and South Korea | Benzinga
- 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 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.
Daix (France), Long Island City (New York, United States), Tokyo (Japan), September 20 2023 – Inventiva (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 ...