NEWARK, Calif., Jan. 08, 2018 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ:CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today 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,” said Ben Stakely, President and CEO of Kowa Pharmaceuticals America. He added, “It is gratifying to see the hard work of our teams come to fruition with the initiation of this study.”
CymaBay Exclusive Licensing Agreement with Kowa Pharmaceuticals America, Inc.
In December 2016, CymaBay entered into an exclusive license agreement with Kowa Pharmaceuticals America, Inc. for the development and commercialization of arhalofenate in the U.S. Pursuant to the license agreement, Kowa has exclusive rights to develop, use, manufacture and commercialize arhalofenate in the United States (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 U.S.
CymaBay Therapeutics, Inc. (CBAY) 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 U.S. to Kowa Pharmaceuticals America, Inc. CymaBay retains full development and commercialization rights for arhalofenate outside the U.S.
About Kowa Pharmaceuticals America, Inc.
Kowa Pharmaceuticals America, Inc., headquartered in Montgomery, Alabama, 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.
The statements in this press release regarding the potential for arhalofenate to treat gout, the potential for seladelpar to treat PBC and/or NASH, the potential benefits to patients of these product candidates, the expectations regarding future clinical trials, and the expectation that CymaBay’s partnership with Kowa will continue and will be successful are forward looking statements that are subject to risks and uncertainties. Actual results and the timing of events regarding the further development of arhalofenate and seladelpar could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties, which include, without limitation, risks related to: the success, cost and timing of any of CymaBay's product development activities, including clinical trials; effects observed in trials to date that may not be repeated in the future; any delays or inability to obtain or maintain regulatory approval of CymaBay's product candidates in the United States or worldwide; and the ability of CymaBay to obtain sufficient financing to complete development, regulatory approval and commercialization of its product candidates in the United States and worldwide. Additional risks relating to CymaBay are contained in CymaBay's filings with the Securities and Exchange Commission, including without limitation its most recent Quarterly Report on Form 10-Q, Annual Report on Form 10-K and other documents subsequently filed with or furnished to the Securities and Exchange Commission. CymaBay disclaims any obligation to update these forward-looking statements except as required by law.
For additional information about CymaBay visit www.cymabay.com.
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