Kite Pharma, Inc. and Daiichi Sankyo Co., Ltd. have revised their existing agreement, a press release reported.
“As the global leader in cell therapy, we are pleased that our partnership with Daiichi Sankyo has brought this innovative therapy to patients in Japan,” Christi Shaw, CEO of Kite, said. “We look forward to building on the momentum to accelerate efforts in Japan to maximize access and impact for patients as part of Gilead and Kite’s expansion into oncology in Japan.”
Under the terms of the updated deal, Marketing Authorization for Yescarta will be transferred to Gilead Sciences K.K. next year.
A Gilead Sciences K.K.-based unit, Kite Cell Therapy Business Unit will be tasked with managing promotion activities in Japan following the authorization transfer.
Initially established in 2017, the agreement between Kite Pharma, Inc. and Daiichi Sankyo Co. grants Daiichi Sankyo exclusive rights to develop, manufacture and commercialize Yescarta in Japan.
Kite’s second manufacturing site in El Segundo, California, U.S. received the greenlight from Japanese regulatory authorities to manufacture Yescarta for Japan, and has scheduled supply production to begin in early 2023, following successful operations at the first approved axicabtagene ciloleucel treatment center in Japan.
Now there are six existing Japanese hospitals authorized to conduct the therapy.
“We are confident that these changes will benefit patients in Japan by increasing capacity and support broader patient access to this important treatment for blood cancer patients and we remain committed to working together with Kite to ensure a smooth transfer during this transitional period,” senior executive officer, head of Japan Business Unit of Daiichi Sankyo, Shoji Hirashima, said.