CymaBay Therapeutics, Inc. announced that it has entered into a collaboration and license agreement with Kaken Pharmaceutical Co. Ltd. for the development and commercialization in Japan of CymaBay's investigational drug seladelpar for the treatment of primary biliary cholangitis (“PBC”). 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.