– Kite and Daiichi Sankyo extend YESCARTA^® Collaboration in Japan –

SANTA MONICA, California & TOKYO, December 16, 2021– (BUSINESS WIRE) – Kite, a Gilead Company, and Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced today that YESCARTA^® (axicabtagene ciloleucel), a chimeric antigen receptor (CAR) T-cell therapy, will be available for patients with relapsed or refractory large B-cell lymphomas in Japan through the first treatment center now authorized by Daiichi Sankyo. Kite and Daiichi Sankyo will also rely on the exclusive license agreement for the rights to market axicabtagene ciloleucel in Japan, formalized in January 2017. The two partners are pleased to agree to an expansion of their commercial collaboration in Japan.

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“We are delighted to bring the benefits of axicabtagene ciloleucel to eligible patients in Japan, together with Daiichi Sankyo,” said Warner Biddle, Kite Global Business Director. “Japan has the second highest number of people diagnosed with non-Hodgkin lymphoma in the world¹ and we remain committed to bringing our innovative CAR T cell therapies to new markets. “

“We are delighted to be able to provide axicabtagene ciloleucel, Daiichi Sankyo’s first cell therapy product, to patients in Japan,” said Akio Sakurai, Daiichi Sankyo Corporate Officer, Head of Sales Division. “By strengthening our collaboration with Kite, the initiator of axicabtagene ciloleucel and a world leader in cell therapy, we will strive to bring this innovative therapy to as many patients as possible.

CAR T-cell therapy is a complex immunotherapy, and all hospitals should go through a rigorous training process before administering axicabtagene ciloleucel to patients. These hospitals receive specific training in handling and risk minimization procedures to ensure patient safety remains a priority.

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Several factors are taken into account when qualifying a hospital, including its specialist skills and services, geographic coverage and experience in handling other complex procedures, such as stem cell transplantation and a care unit. collocated intensive.

Axicabtagene ciloleucel has been approved in Japan for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, transformed follicular lymphoma or B-cell lymphoma. ranking officer. The use of axicabtagene ciloleucel is limited to patients not previously treated with an infusion of CAR-positive CD-19 T cells; patients previously treated with two or more lines of treatment, including chemotherapy or autologous stem cell transplantation; and patients ineligible for autologous stem cell transplantation. In January 2017, Daiichi Sankyo received the exclusive rights to develop, manufacture and market axicabtagene ciloleucel in Japan from Kite, a Gilead company based in California.

Axicabtagene ciloleucel approval in Japan is based on data from Kite’s global pivotal trial (ZUMA-1)² and the results of a phase 2 study conducted by Daiichi Sankyo in Japan. In the Japanese phase 2, open-label, single-arm study, the same dose (2.0 x 10⁶ cells / kg) of axicabtagene ciloleucel as used in study ZUMA-1 was administered to evaluate efficacy and safety in 16 Japanese patients with relapsed or refractory large B-cell lymphoma, including including diffuse large B-cell lymphoma, mediastinal primary B-cell lymphoma, transformed follicular lymphoma, or high-grade B-cell lymphoma. The study met its primary endpoint, demonstrating an objective response rate (ORR) of 86.7% (95% CI: 59.5 – 98.3%).

The overall safety and tolerability profile of axicabtagene ciloleucel in the Japanese trial was consistent with that observed in ZUMA-1. No dose limiting toxicity was observed. A Grade ≥ 3 treatment-related adverse event occurred in all patients; most often neutropenia (81.3%), lymphopenia (81.3%) and thrombocytopenia (62.5%). Cytokine release syndrome (CRS), a typical adverse event related to CAR T cell therapy, occurred in 13 patients (81.3%, all grades), with CRS ≥ grade 3 in one patient (6, 3%). No neurological event, another adverse event related to treatment with CAR T cells, was observed.

About YESCARTA^®

OUICARTA^® (axicabtagene ciloleucel) is a CAR T cell therapy directed against CD19 (a cell membrane protein), which harnesses the patient’s immune system to fight cancer. Axicabtagene ciloleucel is made by taking a patient’s T cells and manipulating them in the laboratory to express chimeric antigen receptors so that they can recognize and destroy cancer cells. CAR T therapy is made specifically for each patient and administered only once.³

Axicabtagene ciloleucel received Orphan Drug Designation from MHLW of Japan in 2018 for the treatment of diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, transformed follicular lymphoma and high-grade B lymphoma.

OUICARTA^® is approved in the United States and Europe for patients with certain types of relapsed or refractory B cell lymphoma, where it is developed, manufactured and marketed by Kite.

Please see full prescribing information in the United States, including WARNING IN BOX and Medication Guide.

Ouicarta^® is an immunotherapy of genetically modified autologous T cells directed against CD19, indicated for the treatment of:

• Adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, High-grade B lymphoma and DLBCL resulting from follicular lymphoma.

Limits of use: Yescarta is not indicated for the treatment of patients with primary lymphoma of the central nervous system.

• Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This indication is approved under expedited approval based on response rate. Continued approval for this indication may depend on verification and description of clinical benefit in the confirmatory trial (s).

About Daiichi Sankyo

Daiichi Sankyo is dedicated to creating new modalities and innovative medicines by leveraging our world-class science and technology with the aim of “contributing to the enrichment of the quality of life in the world”. In addition to our current portfolio of cancer and cardiovascular disease drugs, Daiichi Sankyo is primarily focused on the development of new therapies for people with cancer as well as other diseases for which there are significant unmet medical needs. With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world are building on a rich heritage of innovation to achieve our Vision 2030 and become a “Global Company of innovative healthcare contributing to sustainable development of society. “For more information, please visit: www.daiichisankyo.com.

About kite

Kite, a Gilead company, is a global biopharmaceutical company headquartered in Santa Monica, California, with manufacturing operations in North America and Europe. Kite’s singular goal is cell therapy to treat and potentially cure cancer. As a leader in cell therapy, Kite has more CAR T indications approved to help more patients than any other company. For more information about Kite, please visit www.kitepharma.com.

Forward-looking statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 which are subject to risks, uncertainties and other factors, including Kite’s ability to realize the expected benefits from working with Daiichi Sankyo or other investments in therapy; Ability of Kite to initiate, progress or complete clinical trials or studies on time or not at all, including those involving YESCARTA^®; the possibility of adverse results from ongoing or additional clinical trials or studies, including those involving YESCARTA^®; the risk that doctors may not see the benefit of prescribing YESCARTA^®; the possibility that the processing center experiences disruptions or difficulties in delivering YESCARTA^® to patients; and any assumptions underlying all of the above. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, as filed with the United States Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those mentioned in forward-looking statements. All statements other than statements of historical fact are statements which could be considered as forward-looking statements. The reader is cautioned that these forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and are cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead and Kite, and Gilead and Kite assume no obligation and disclaim any intention to update these forward-looking statements.

US Prescribing Information for YESCARTA^® including WARNING IN BOX, is available at www.kitepharma.com and www.gilead.com.

Kite, the Kite logo, YESCARTA, and GILEAD are registered trademarks of Gilead Sciences, Inc. or its related companies.

For more information about Kite, please visit the company’s website at www.kitepharma.com Follow Kite on social media on Twitter (@KitePharma) and LinkedIn.

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1. Globocan 2020. Available at: https://gco.iarc.fr. Accessed November 2021.

2. Neelapu S. et al. Axicabtagene Ciloleucel CAR T-Cell Therapy in refractory large cell lymphoma B. N Engl J Med. Dec 2017; 377 (26): 2531-2544.

3. Roberts Z, et al. Leukemia and lymphoma. Volume 59, 2018 – Number 8 Pages 1785-1796 | 23 October 2017.

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Contacts

Mary Lynn Carver, Kite Global
[email protected]
+1 410-443-1853 (mobile)

Masashi Kawase, Daiichi Sankyo Co., Ltd. Japan
[email protected]
+81 3 6225 1126 (office)