CymaBay Therapeutics has received a $5 million milestone payment from Kowa Pharmaceuticals America for the initiation of a study evaluating the pharmacokinetics (PK) of arhalofenate in subjects with renal impairment.
“We are pleased with Kowa’s continued commitment to advancing the development of arhalofenate for patients with gout,” said Sujal Shah, president and chief executive officer of CymaBay. “The initiation of the renal PK study is a key step toward Phase 3 development. We believe data from this study has the potential to support enrollment criteria for Phase 3 that could further differentiate arhalofenate from other treatments available for patients with gout.”
In the initial December 2016 exclusive license agreement, CymaBay partnered with Kowa for the development and commercialization of arhalofenate in the U.S. Under the agreement, Kowa has exclusive rights to develop, use, manufacture and commercialize arhalofenate in the United States (including its possessions and territories). Besides the upfront $5 million payment in January 2017 and the milestone payment of $5 million this month, Kowa has also agreed to pay an additional milestone payment of $5 million on the initiation of Phase 3, as well as potential milestone payments of $190 million upon the achievement of additional development and sales milestones, and tiered, double digit royalties on future net sales of arhalofenate products.