On January 8, 2023 CymaBay Therapeutics, Inc. (NASDAQ: CBAY) ("CymaBay" or the "Company") reported that it has entered into a collaboration and license agreement with Kaken Pharmaceutical Co., Ltd. ("Kaken") for the development and commercialization in Japan of CymaBay’s investigational drug seladelpar for the treatment of primary biliary cholangitis ("PBC") (Press release, CymaBay Therapeutics, JAN 8, 2023, View Source [SID1234625997]).
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Under the terms of the agreement, Kaken receives an exclusive license to develop, commercialize and market seladelpar in Japan for PBC. Kaken will make an upfront payment to CymaBay of ¥4.5 billion (approximately $34.0 million at current exchange rates) with additional potential milestone payments to CymaBay totaling up to ¥17.0 billion (approximately $128.4 million at current exchange rates) for the achievement of certain regulatory and sales milestones in addition to 20+% royalties. Kaken will be responsible for development, regulatory approval and commercialization of seladelpar in Japan.
There are currently no approved second line treatments for PBC in Japan, representing a significant unmet medical need for PBC patients in Japan.
"We are honored to collaborate with Kaken, a company that shares our passion and dedication to working together to bring to market novel therapies targeting serious rare diseases," said Sujal Shah, Chief Executive Officer of CymaBay. "Kaken is a well-regarded leader in development and commercialization in Japan with a proud history of scientific and medical innovation. By working together, we believe that if approved, we can potentially make seladelpar broadly available to Japanese patients to complement CymaBay’s efforts to provide access in the U.S. and other parts of the world. This collaboration is an important next step in achieving our vision of becoming the global leader in treating cholestatic liver diseases."
"We are pleased to begin a collaboration with CymaBay, a company with a strong passion toward developing novel therapeutics for cholestatic liver diseases," said Hiroyuki Horiuchi, President and Representative Director of Kaken. "With this collaboration, we hope we can help improve the lives of patients with cholestatic liver disease in Japan."