On January 6, 2020 Taiho Pharmaceutical Co, Ltd., ("Taiho") reported an exclusive worldwide research collaboration and license agreement with Astex Pharmaceuticals (UK), a wholly owned subsidiary of Otsuka Pharmaceutical Co., Ltd. ("Astex"), and a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, known as MSD outside the United States and Canada ("MSD") focused on the development of small molecule inhibitors against several drug targets, including the KRAS oncogene, which are currently being investigated for the treatment of cancer (Press release, Taiho, JAN 6, 2020, View Source [SID1234552700]).

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"Taiho has used its unique and proprietary drug discovery platform to generate a number of small molecule inhibitors," said Teruhiro Utsugi, Ph.D., managing director at Taiho. "This alliance builds on our KRAS research up to now, and together with MSD it allows us to combine expertise to significantly accelerate the global research, development and commercialization of a number of our mutant KRAS programs by accessing external talent and resources."

Under the terms of the agreement, Taiho, Astex and MSD will combine preclinical candidates and their data with knowledge and expertise from their respective research programs. In exchange for providing MSD an exclusive global license to their small molecule inhibitor candidates, Taiho and Astex will receive an aggregate upfront payment of $50 million and will be eligible to receive approximately $2.5 billion contingent upon the achievement of preclinical, clinical, regulatory and sales milestones for multiple products arising from the agreement, as well as tiered royalties on sales. MSD will fund research and development and will be responsible for commercialization of products globally. Taiho has retained co-commercialization rights in Japan and an option to promote in specific areas of South East Asia.

"At MSD we continue to pursue new regimens designed to extend the benefits of highly selective therapies to more patients with cancer," said Dr. Roger M. Perlmutter, president, MSD Research Laboratories. "This agreement with Taiho and Astex combines our respective small molecule assets and industry-leading expertise in cancer cell signaling to enable development of the most promising drug candidates."

Harren Jhoti, Ph.D., president and CEO of Astex Pharmaceuticals (UK), commented,

"Together with our Taiho colleagues we are delighted to be working with MSD, one of the global leaders in oncology drug development, on this strategic alliance. This collaboration is another testament to Astex’s position as the leader in fragment-based drug discovery."

KRAS is among the most frequently mutated oncogenes in human cancers. It is estimated to occur in approximately 90% of pancreatic cancers1 and 20% of non-small cell lung cancers (NSCLC)2, where they are associated with poorer outcomes.

1: Journal of Cell Science (2016) 129, 1287-1292
2: Journal of the National Comprehensive Cancer Network; Cancer Genome Atlas Research N. Nature 2014;511:543-50