NEW YORK – Gilead Sciences subsidiary Kite Pharma and Daiichi Sankyo on Wednesday announced that beginning in 2023 Daiichi Sankyo will no longer own the rights to market Yescarta (axicabtagene ciloleucel) in Japan.
Instead, Yescarta's license in Japan will belong to Gilead Sciences K.K., Gilead's Japan-based subsidiary. The change comes after an initial agreement in 2017, whereby Kite — then independent from Gilead — granted Daiichi Sankyo the exclusive rights to develop, manufacture, and commercialize Yescarta in Japan.
Now, a cell therapy business unit under Kite, which falls under Gilead Sciences K.K. ownership, will manage the autologous CAR T-cell therapy's sales and promotional activities in Japan.
In tandem with the licensing shift, Japanese regulators have said they will allow Kite's US-based cell therapy manufacturing center to supply Yescarta for use in Japan, which is expected to start happening in early 2023.
In Japan, Yescarta is approved as treatment for certain patients with relapsed or refractory diffuse large B-cell lymphoma; and primary mediastinal B-cell lymphoma, transformed follicular lymphoma, or high-grade B-cell lymphoma.
"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," Shoji Hirashima, a senior executive officer at Daiichi Sankyo and head of the firm's Japan business unit, said in a statement. "We remain committed to working together with Kite to ensure a smooth transfer during this transitional period."