On January 6, MSD announced that it had entered into a global exclusive collaboration and licensing agreement with Taiho Pharmaceutical Co., Ltd. and Astex Pharmaceuticals, a wholly owned subsidiary of Otsuka Pharmaceutical Co., Ltd., for the co-development and commercialization of small-molecule oncology inhibitors.
Taiho Pharmaceutical, a subsidiary of Otsuka, is a well-known specialty pharmaceutical R&D company in Japan, focusing on three therapeutic areas: oncology, allergy and immunology, and urology. Merck Sharp & Dohme (MSD) previously collaborated with Taiho Pharmaceutical to co-promote Keytruda in Japan. The commercial promotion partnership between the two companies for Keytruda officially concluded at the end of December.
Under the terms of this latest collaboration agreement, MSD, Dapeng, and Astex will share technologies and knowledge data related to preclinical candidate compound screening and their respective research projects. MSD has obtained exclusive global rights to small-molecule inhibitor candidates from Dapeng and Astex, paying them a $50 million upfront payment, with an additional potential total of $2.5 billion in milestone payments and royalties across preclinical, clinical, regulatory registration, and commercialization stages for multiple drugs covered under the agreement. Furthermore, MSD will bear the research and development costs for the relevant drugs and be responsible for their global commercialization. Dapeng retains co-commercialization rights for the relevant drugs in Japan, as well as options for commercial promotion in specific regions of Southeast Asia.
Dr. Teruhiro Utsugi, General Manager of Taiho Pharmaceutical, stated: “Taiho possesses a proprietary drug discovery platform that has identified a substantial number of promising small-molecule inhibitors. This collaboration with MSD will strengthen our KRAS research, and the combination of both parties’ resources will accelerate the global development of multiple programs targeting KRAS mutations.”
Taiho Product Pipeline (Source: Taiho Pharmaceutical Official Website)
KRAS is one of the most common oncogenic mutations, with a mutation rate exceeding 90% in pancreatic cancer and approximately 20% in non-small cell lung cancer. KRAS mutations are closely associated with poor prognosis in cancer patients.
MSD has capitalized on the two major oncology trends of PD-1 and PARP inhibitors, while also taking proactive measures in the KRAS therapeutic arena. This collaboration with Taiho Pharmaceutical is not its first foray into KRAS-focused development. Last May, MSD and Moderna Therapeutics announced an expanded partnership to develop and promote novel personalized mRNA cancer vaccines, including Moderna’s mRNA-5671 targeting KRAS mutations.
mRNA-5671 encodes the four most common KRAS mutations. Under the expanded agreement between MSD and Moderna, MSD will be responsible for the clinical development of mRNA-5671, while Moderna will be responsible for supplying clinical samples. Upon completion of proof-of-concept studies, MSD may elect to further develop and commercialize mRNA-5671 upon payment of certain fees to Moderna. As part of the agreement, the two parties may also initiate and conduct collaborations on other shared-antigen mRNA cancer vaccine programs.