Daiichi Sankyo Returns Yescarta Commercial Rights in Japan to Gilead

On December 8, Daiichi Sankyo announced that it would transfer the sales rights of the CAR-T cell therapy Yescarta in Japan to Gilead’s Japanese division.

Yescarta, developed by Kite Pharma (hereinafter referred to as Kite), a subsidiary of Gilead, was approved by the FDA in October 2017. It is the first CAR-T cell therapy for adult patients with relapsed or refractory large B-cell lymphoma (LBCL).

In January 2017, Daiichi Sankyo obtained Yescarta from Kite Pharma and secured exclusive rights for the drug’s development, manufacturing, and commercialization in Japan. In January 2021, Japan's Ministry of Health, Labour and Welfare (MHLW) approved Yescarta for treating certain adult patients with relapsed/refractory LBCL. In December of the same year, Japan's first Yescarta treatment center was approved, and currently, six hospitals are authorized to administer this personalized therapy.

According to the revised agreement, the Kite Cell Therapy division of Gilead Japan branch, Gilead Sciences K.K., will be responsible for the sales and promotion of Yescarta in Japan in 2023.

Currently, Yescarta is priced at $373,000 per dose in the U.S. market. In 2020, Yescarta generated sales of $563 million, and in 2021, sales further increased to $695 million. Just in the first half of this year, Yescarta’s sales have already exceeded $500 million.

CAR-T therapy is a personalized treatment that combats cancer by modifying patients' own T cells. Due to its complex manufacturing process, the supply of many CAR-T therapies struggles to meet demand.

To ensure a stable supply and reduce turnaround time, Kite Pharma has heavily invested in its manufacturing operations. During the pandemic, the company received approval for its Amsterdam facility. Meanwhile, in the United States, Kite Pharma’s manufacturing plant in El Segundo, California, has been approved by Japanese regulatory authorities to produce Yescarta for patients in Japan, with supply expected to begin in early 2023.

Shoji Hirashima, head of Daiichi Sankyo's Japanese operations, said in a statement that the change in the licensing agreement would benefit patients in Japan. They will increase capacity to allow more patients access to this important blood cancer therapy and will continue to work with Kite Pharma to ensure a smooth transition during this period.

Kite Pharma CEO Christi Shaw also expressed her delight at building on the momentum of "accelerating Japan's efforts to maximize patient access and impact."

CAR-T personalized products like Yescarta that face capacity issues are not unique. Earlier last year, BMS disclosed that the demand for its newly launched multiple myeloma drug Abecma had exceeded production capacity. According to real-world data shown on the websites of Kite Pharma and BMS, the average time from blood extraction from patients to the final product for Yescarta is 16 days, while for BMS, it takes 24 days.

Abecma was co-developed, co-promoted, and its profits shared by BMS and Bluebird Bio. Subsequently, Bluebird Bio spun off its oncology pipeline to establish the independent company 2seventy bio, into which Abecma was incorporated. To meet market demand, 2seventy bio and BMS will focus on enhancing the capabilities of the entire supply chain.

Reference Article:

1、Daiichi Sankyo walks back Yescarta marketing deal with Gilead, Kite；fiercepharma

2. How has the commercialization of CAR-T therapy, which costs up to nearly $500,000, been carried out in the U.S. and other overseas countries?; Tongxieyi

Editor: Dadasiva

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