Spruce Biosciences Enters Strategic Partnership to Deliver Tildacerfont to Japanese Market

Late-stage biopharmaceutical company, Spruce Biosciences (Nasdaq: SPRB), has announced an exclusive licensing agreement with Kaken Pharmaceuticals to develop and commercialize tildacerfont for congenital adrenal hyperplasia (CAH) in Japan.

(CAH) is a genetic disorder in which the two adrenal glands (located at the top of the kidneys) do not function properly. The Company estimates the total classic CAH population to be approximately 20,000-30,000 people in the U.S., approximately 50,000 people in the EU, and at least 145,000 people in China, representing a ~$3B+ market opportunity with a high unmet need.

Spruce’s product candidate, tildacerfont, has been evaluated in eight clinical trials in 235 patients. It has been granted orphan drug status by the FDA and the European Medicines Agency for the treatment of classic CAH.

Highlights

• Under the terms of the agreement, Spruce will receive an upfront payment of $15 million from Kaken.
• The company will also 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.

As part of the deal, Kaken will be responsible for the clinical development and commercialization of tildacerfont in Japan, while Spruce retains rights to tildacerfont in all other geographies.