CymaBay Therapeutics, a clinical-stage biopharma company, has entered into an exclusive license agreement with Kowa Pharmaceuticals America for the development and commercialization in the U.S. of arhalofenate, an oral, once-daily dual-acting drug candidate for the treatment of gout.  

CymaBay will receive up to $15 million in upfront and near-term milestone payments and is eligible to receive up to an additional $190 million in payments based upon the achievement of specific development, regulatory and sales milestones. CymaBay is also eligible to receive tiered, double digit royalties on future sales of arhalofenate products.  Kowa will be responsible for all development and commercialization costs. CymaBay had earlier reached agreement with the U.S. FDA on the size and scope of the Phase 3 program which is estimated to cost $100 million. CymaBay retains full development and commercialization rights for the rest of the world.

“We are extremely pleased to enter into this agreement with Kowa to develop and market arhalofenate in the U.S. Kowa has proven development capabilities as well as the resources to carry out a large Phase 3 development program. They also have an established primary care sales force to market arhalofenate products,” said Harold Van Wart, president and chief executive officer, CymaBay. “As arhalofenate is a potential novel therapy for gout, a disease most often treated by primary care physicians, it is a very good fit with Kowa’s established strength in this area. Identifying a partner to complete the Phase 3 development and commercialization of arhalofenate has been a key part of CymaBay’s strategy. It enables us to advance arhalofenate to the market while allowing us to focus our internal resources on the rest of our pipeline which addresses serious and rare disorders.”