CymaBay Therapeutics Receives $5-Million Milestone Payment

CymaBay Therapeutics, Inc. recently announced it 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.”

“We find that both the anti-inflammatory and uricosuric actions of arhalofenate are unique in their potential to address the unmet needs of gout patients,” added Ben Stakely, President and CEO of Kowa Pharmaceuticals America. “It is gratifying to see the hard work of our teams come to fruition with the initiation of this study.”

In December 2016, CymaBay entered into an exclusive license agreement with Kowa Pharmaceuticals America, Inc. for the development and commercialization of arhalofenate in the US Pursuant to the license agreement, Kowa has exclusive rights to develop, use, manufacture, and commercialize arhalofenate in the US (including its possessions and territories). Under the license agreement, Kowa paid CymaBay an up-front payment of $5 million in January 2017, a milestone payment of $5 million in January 2018, and has 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. Kowa is responsible for all development and commercialization costs in the US.

CymaBay Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet medical need. Seladelpar is a potent and selective agonist of PPARδ, a nuclear receptor that regulates genes involved in bile acid/sterol, lipid and glucose metabolism and inflammation. Seladelpar is currently in development for the treatment of patients with the autoimmune liver disease, primary biliary cholangitis (PBC) and nonalcoholic steatohepatitis (NASH). Two Phase 2 studies of seladelpar established proof of concept in PBC. CymaBay is currently planning to advance development of seladelpar into Phase 3 for PBC and Phase 2 for NASH. Arhalofenate is a potential urate-lowering anti-flare therapy that has been found to reduce painful flares in joints while at the same time lowering serum uric acid by promoting excretion of uric acid by the kidney. This dual action addresses both the signs and symptoms of gout while managing the underlying pathophysiology of hyperuricemia. Arhalofenate has been licensed in the US to Kowa Pharmaceuticals America, Inc. CymaBay retains full development and commercialization rights for arhalofenate outside the US. For more information, visit www.cymabay.com.

Kowa Pharmaceuticals America, Inc., headquartered in Montgomery, AL, is focused primarily in the area of cardiometabolic diseases. Established in 2008, Kowa Pharmaceuticals America focuses its efforts on the successful commercialization of its current and near-term portfolio of pharmaceutical products and business development activities.