Spruce Biosciences, Inc. and Kaken Pharmaceutical Co. Ltd. announced that the companies have entered into an exclusive licensing agreement for the development and commercialization of Spruce's product candidate, tildacerfont, for the treatment of congenial adrenal hyperplasia (CAH) in Japan. Under the terms of the agreement, Spruce will receive an upfront payment of $15 million from Kaken and will be eligible to receive additional payments upon the achievement of future development and commercial milestones, as well as tiered double-digit royalties on net sales in Japan.

Kaken will be responsible for the clinical development and commercialization of tildacerfont in Japan, and Spruce will retain all rights to tildacerfont in all other geographies. As part of the agreement, Kaken will have the first right of negotiation to expand the scope of the agreement to include China (including Hong Kong, Taiwan, and Macau), South Korea and other specified Southeastern Asian (ASEAN) countries. Kaken will also be responsible for securing and maintaining regulatory approvals necessary to market and sell tildacerfont in Japan.