January 05 2023 - 04:00PM
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Partnership aims to accelerate global development and commercialization plans for tildacerfont to address worldwide unmet medical need in congenital adrenal hyperplasia (CAH)
Deal advances strategy to partner tildacerfont commercial rights outside the United States
Spruce to receive $15 million upfront payment plus development and commercial milestone payments in addition to tiered double-digit royalties on net sales in Japan
Spruce 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.
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.
“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 tildacerfont and bringing a new treatment option to CAH patients in Japan, if approved.”
“We are pleased to begin a collaboration with Spruce, a company committed to transforming the lives of patients with CAH,” said Hiroyuki Horiuchi, President and Representative Director of Kaken. “Through this collaboration, we hope we can contribute to CAH patients and their families, who currently have limited available treatment options in Japan.”
About Tildacerfont
Tildacerfont is a potent and highly selective, non-steroidal, oral antagonist of the corticotropin-releasing factor (CRF) 1 receptor. The CRF1 receptor is abundantly expressed in the pituitary gland where it is the primary regulator of the hypothalamic-pituitary-adrenal (HPA) axis. By antagonizing the CRF1 receptor, tildacerfont has the potential to address the uncontrolled cortisol feedback regulatory pathway in CAH, and in turn reduce the production of adrenocorticotropic hormone (ACTH) in the pituitary, limiting the amount of androgen produced downstream from the adrenal gland. Tildacerfont has been evaluated in 235 patients across eight clinical trials in which it has been generally well tolerated. No drug-related serious adverse events have been reported across completed clinical trials. Tildacerfont is currently being evaluated in clinical trials for adult classic CAH, pediatric classic CAH, and polycystic ovary syndrome.
About Spruce Biosciences
Spruce Biosciences is a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for rare endocrine disorders with significant unmet medical need. Spruce is initially developing its wholly-owned product candidate, tildacerfont, as the potential first non-steroidal therapy for patients suffering from classic congenital adrenal hyperplasia (CAH). Spruce is also developing tildacerfont for women suffering from polycystic ovary syndrome (PCOS) with primary adrenal androgen excess. To learn more, visit www.sprucebiosciences.com and follow Spruce on Twitter @Spruce_Bio, LinkedIn, Facebook and YouTube.
About Kaken Pharmaceutical
Kaken Pharmaceutical is a specialty pharmaceutical company in Japan with strong experience in developing and commercializing novel pharmaceuticals in the fields of orthopedics and dermatology. Kaken concentrates its R
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