Business
Spruce Biosciences and Kaken Pharmaceutical Announce Strategic Partnership and Exclusive Licensing Agreement to Develop and Commercialize Tildacerfont for CAH in Japan
Partnership aims to accelerate global development and commercialization plans for tildacerfont to address worldwide unmet medical need in congenital adrenal
About this update from Spruce Biosciences, Inc.
[{"type":"text","content":"\nPartnership aims to accelerate global development and commercialization plans for tildacerfont to address worldwide unmet medical need in congenital adrenal hyperplasia (CAH)\n\nDeal advances strategy to partner tildacerfont commercial rights outside the United States\n\nSpruce to receive $15 million upfront payment plus development and commercial milestone payments in addition to tiered double-digit royalties on net sales in Japan\n\n SOUTH SAN FRANCISCO, Calif. & TOKYO--(BUSINESS WIRE)--\nSpruce Biosciences, Inc. (Nasdaq: SPRB) and Kaken Pharmaceutical Co. Ltd (Tokyo Stock Exchange: 4521) today 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.\n\nUnder 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.\n\n“We are excited to enter into this strategic partnership with Kaken Pharmaceutical designed to accelerate our global development plans and bring tildacerfont to patients in Japan who suffer from CAH,” said Javier Szwarcberg, M.D., M.P.H., Chief Executive Officer of Spruce Biosciences. “As a specialty pharmaceutical company with a strong presence in Japan, Kaken is the ideal strategic partner for the territory, and supports Spruce’s partnering strategy to develop tildacerfont in markets outside of the United States. We believe Kaken’s track record of development and commercialization in the Asia-Pacific region will be instrumental in delivering the full therapeutic potential of ti...