Post by icemandios on Jan 9, 2023 16:50:25 GMT
CymaBay Therapeutics Announces Collaboration with Kaken Pharmaceutical Co., Ltd. to Develop and Commercialize Seladelpar in Japan for Primary Biliary Cholangitis
Advances strategy to partner seladelpar for PBC outside U.S.
Brings in approximately $34.0 million upfront payment
Japan represents an important market with no currently approved second line treatment
NEWARK, Calif. and TOKYO, Jan. 08, 2023 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY) (“CymaBay” or the “Company”) announced today 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”).
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 ÂĄ4.5 billion (approximately $34.0 million at current exchange rates) with additional potential milestone payments to CymaBay totaling up to ÂĄ17.0 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.”
About CymaBay
CymaBay Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on improving the lives of people with liver and other chronic diseases that have high unmet medical need through a pipeline of innovative therapies. Our deep understanding of the underlying mechanisms of liver inflammation and fibrosis, and the unique targets that play a role in their progression, have helped us receive breakthrough therapy designation (U.S. Food and Drug Administration), PRIority MEdicines status (European Medicines Agency) and orphan drug status (U.S. and Europe) for seladelpar, a first-in-class treatment for people with primary biliary cholangitis (PBC). Our evidence-based decision-making and commitment to the highest quality standards reflect our relentless dedication to the people, families and communities we serve. To learn more, visit www.cymabay.com and follow us on Twitter and Linkedin .
About Kaken
Kaken (Tokyo Stock Exchange: 4521) is a specialty pharmaceutical company in Japan with strong experience in developing and commercializing novel pharmaceuticals in the fields of orthopedics and dermatology. Kaken concentrates its R&D resources in areas such as immune system, nervous system, infectious diseases and rare diseases with unmet medical needs. Kaken, in its philosophy, strives to improve the quality of life of patients through the development and distribution of superior pharmaceuticals. For more information, please visit www.kaken.co.jp/english/ .
Advances strategy to partner seladelpar for PBC outside U.S.
Brings in approximately $34.0 million upfront payment
Japan represents an important market with no currently approved second line treatment
NEWARK, Calif. and TOKYO, Jan. 08, 2023 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY) (“CymaBay” or the “Company”) announced today 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”).
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 ÂĄ4.5 billion (approximately $34.0 million at current exchange rates) with additional potential milestone payments to CymaBay totaling up to ÂĄ17.0 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.”
About CymaBay
CymaBay Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on improving the lives of people with liver and other chronic diseases that have high unmet medical need through a pipeline of innovative therapies. Our deep understanding of the underlying mechanisms of liver inflammation and fibrosis, and the unique targets that play a role in their progression, have helped us receive breakthrough therapy designation (U.S. Food and Drug Administration), PRIority MEdicines status (European Medicines Agency) and orphan drug status (U.S. and Europe) for seladelpar, a first-in-class treatment for people with primary biliary cholangitis (PBC). Our evidence-based decision-making and commitment to the highest quality standards reflect our relentless dedication to the people, families and communities we serve. To learn more, visit www.cymabay.com and follow us on Twitter and Linkedin .
About Kaken
Kaken (Tokyo Stock Exchange: 4521) is a specialty pharmaceutical company in Japan with strong experience in developing and commercializing novel pharmaceuticals in the fields of orthopedics and dermatology. Kaken concentrates its R&D resources in areas such as immune system, nervous system, infectious diseases and rare diseases with unmet medical needs. Kaken, in its philosophy, strives to improve the quality of life of patients through the development and distribution of superior pharmaceuticals. For more information, please visit www.kaken.co.jp/english/ .