4SC AG and Yakult Honsha Co.; Ltd. have announced the grant of an exclusive license by 4SC to Yakult Honsha for the development and commercialization of resminostat in Japan.
Resminostat, an oral, pan-histone deacetylase (HDAC) inhibitor, is currently being evaluated in Phase II trials by 4SC in hepatocellular carcinoma (HCC), Hodgkin lymphoma (HL) and colorectal cancer in KRAS-mutant patients (CRC).
Yakult Honsha will develop and commercialize resminostat primarily in HCC, CRC and retains the rights to develop and commercialize resminostat in other oncology indications in Japan.
Terms of the Agreement
4SC will receive an upfront payment from Yakult Honsha of €6 million and up to €127 million payable upon achieving specified milestones including clinical and regulatory events in Japan. In addition to milestone payments, Yakult will pay 4SC double-digit royalties linked to product sales of resminostat, which will also include the API costs.
4SC will be the exclusive supplier of resminostat to Yakult Honsha. Yakult Honsha will be responsible for all development and clinical requirements in Japan for resminostat in HCC, CRC and other chosen oncology indications.
Ulrich Dauer, CEO of 4SC, commented, “We are pleased to be entering this partnership with Yakult Honsha, which validates the potential of resminostat and delivers on our partnering strategy. As Yakult Honsha is the market leader in the gastrointestinal oncology field in Japan, we have found the most suitable partner for our core indications; hepatocellular carcinoma and colorectal cancer. We are looking forward to a mutually rewarding relationship and working together with this partner of choice.”
Shigeyoshi Sakamoto, Head, Pharmaceutical Division/Managing Director, Member of the Board, noted, “We are delighted to establish a partnership with 4SC, an expert in research and development of novel drugs for cancer. We believe that resminostat will contribute to the treatment of difficult cancers such as HCC, for which treatment needs remain to be met, and
also to the treatment of CRC and other types of cancer. The open-label Phase II trials data have provided us with the confidence to more aggressively develop the drug.”