As per the terms of the agreement, Spruce will get an upfront payment of $15m from Kaken.
It will also be eligible to get further payments following the achievement of future development and commercial milestones. It will also be eligible to get tiered double-digit royalties on net sales in Japan.
Kaken will have the responsibility for the clinical development and commercialisation of tildacerfont in Japan, while Spruce will retain all rights to the product candidate in all other geographies.
Under the agreement, Kaken will gain 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.
It will also have the responsibility for securing and maintaining regulatory approvals required to market tildacerfont in Japan.
Spruce Biosciences CEO Javier Szwarcberg said: “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.
“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 commercialisation in the Asia-Pacific region will be instrumental in delivering the full therapeutic potential of tildacerfont and bringing a new treatment option to CAH patients in Japan, if approved.”
Kaken president and representative director Hiroyuki Horiuchi said: “We are pleased to begin a collaboration with Spruce, a company committed to transforming the lives of patients with CAH.
“Through this collaboration, we hope we can contribute to CAH patients and their families, who currently have limited available treatment options in Japan.”
Tildacerfont is a selective, non-steroidal, oral antagonist of the corticotropin-releasing factor (CRF) 1 receptor. It has been evaluated in 235 patients across eight clinical trials and was generally found to be well tolerated.
Currently, tildacerfont is being evaluated in clinical trials for adult classic CAH, pediatric classic CAH, and polycystic ovary syndrome.