Kite Pharma, Daiichi Sankyo revise YESCARTA CAR T-Cell Therapy licensing agreement

Tokyo: Kite Pharma, Inc., a Gilead Company, (hereafter Kite), and Daiichi Sankyo Co., Ltd. have jointly announced the revision of their 2017 partnership agreement, which gave Daiichi Sankyo exclusive rights to develop, manufacture, and commercialize Yescarta (axicabtagene ciloleucel) in Japan.

Kite was acquired by Gilead Sciences, Inc. later in 2017 after the Daiichi Sankyo partnership agreement. Daiichi Sankyo and Kite have now agreed that the Marketing Authorization for Yescarta will be transferred to Gilead Sciences K.K., the Japan subsidiary of Gilead Sciences, Inc., in 2023. A Kite Cell Therapy Business Unit at Gilead Sciences K.K. will manage the sales and promotion activities of the product in Japan after the Marketing Authorization transfer.

Kite's manufacturing facility in El Segundo, California, U.S., has been approved by Japanese regulatory authorities to manufacture Yescarta for the Japanese market, and it is expected that supply will commence in early 2023. The first axicabtagene ciloleucel treatment center in Japan was authorized in December 2021, and there are now six hospitals in Japan authorized to administer 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," said Shoji Hirashima, Senior Executive Officer, Head of Japan Business Unit of Daiichi Sankyo. "As the global leaders in cell therapy, we are pleased that our partnership with Daiichi Sankyo has brought this innovative therapy to patients in Japan. 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," said Christi Shaw, CEO of Kite.

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