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Kite and Daiichi Sankyo Announce Changes to YESCARTA® CAR T-Cell Therapy Licensing Agreement in Japan

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SANTA MONICA, California and TOKYO–()–Kite Pharma, Inc., a Gilead Company, (hereafter Kite) and Daiichi Sankyo Co., Ltd. (hereafter, Daiichi Sankyo) today jointly announced the revision of their 2017 partnership agreement, which granted Daiichi Sankyo exclusive rights to develop, manufacture and market Yescarta (axicabtagene ciloleucel) in Japan. Kite was acquired by Gilead Sciences, Inc. later in 2017 after the Daiichi Sankyo partnership deal. Daiichi Sankyo and Kite have agreed that the marketing authorization for Yescarta will be transferred to Gilead Sciences KK, the Japanese subsidiary of Gilead Sciences, Inc., in 2023. A Kite Cell Therapy Business Unit at Gilead Sciences KK will handle sales and promotion activities of the product in Japan after the transfer of the marketing authorization.

The Kite manufacturing facility in El Segundo, California, USA has been approved by Japanese regulators to produce Yescarta for the Japanese market and supply is expected to begin in early 2023. The first axicabtagene ciloleucel treatment in Japan was licensed in December 2021, and there are now six hospitals in Japan licensed to administer the therapy.

We are confident that these changes will benefit patients in Japan by increasing capacity and supporting broader patient access to this important blood cancer treatment, and remain committed to working with Kite to ensure a smooth transition during this challenging period. transition,” said Shoji Hirashima, Senior Executive Officer, Head of Japan Business Unit at Daiichi Sankyo.

As a global leader in cell therapy, we are delighted that our partnership with Daiichi Sankyo has brought this innovative therapy to patients in Japan. We look forward to using 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 Kiting.

About YESCARTA®

SICARTA® (axicabtagene ciloleucel) is a CAR-T cell therapy directed against CD19 (a cell membrane protein), which uses the patient’s immune system to fight cancer. Axicabtagene ciloleucel is made by removing a patient’s T cells from their blood and engineering them in the laboratory to express chimeric antigen receptors so they can recognize and destroy cancer cells when they are given back into the patient’s body. CAR T therapy is manufactured specifically for each patient and administered only once. Axicabtagene ciloleucel received Orphan drug designation by the Japanese Ministry of Health, Labor and Welfare in 2018 for the treatment of diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, transformed follicular lymphoma and high-grade B-cell lymphoma. Yescarta has been approved in Japan for the treatment of patients with relapsed or refractory large B-cell lymphomas1a type of non-Hodgkin’s lymphoma, in January 2021. Japan has the second-largest number of people diagnosed with non-Hodgkin’s lymphoma globally2.

SICARTA® 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 US Prescribing informationIncluded ATTENTION BOXED and medication guide.

Yescarta® is a genetically modified autologous T-cell immunotherapy directed against CD19 indicated for the treatment of:

  • Adult patients with large B-cell lymphoma refractory to first-line chemoimmunotherapy or relapsing within 12 months of first-line chemoimmunotherapy. (1.1)

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

Usage Restrictions: Yescarta is not indicated for the treatment of patients with primary lymphoma of the central nervous system. (1.1)

  • Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory studies. (1.2)

For full European prescribing information, please visit: https://www.ema.europa.eu/en/medicines/human/EPAR/yescarta

About Kite

Kite, a Gilead Company, is a global biopharmaceutical company headquartered in Santa Monica, California focused on cell therapy to treat and potentially cure cancer. As a global leader in cell therapy, Kite has treated more patients with CAR-T cell therapy than any other company. Kite has the largest in-house cell therapy manufacturing network in the world, encompassing process development, vector manufacturing, clinical trial manufacturing, and commercial product manufacturing. For more information on Kite, visit www.kitepharma.com.

About Daiichi Sankyo

Daiichi Sankyo is dedicated to creating new modalities and innovative medicines by leveraging our world-class science and technology for our purpose”contribute to the enrichment of the quality of life in the world”. In addition to our current portfolio of cancer and cardiovascular disease medicines, Daiichi Sankyo is primarily focused on developing new therapies for people with cancer and other diseases with high unmet medical needs. With more than 100 years of scientific experience and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees worldwide draw on a rich legacy of innovation to realize our 2030 vision to become a “Innovative global healthcare company contributing to the sustainable development of society. For more information please visit: www.daiichisankyo.com.

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved medical advances for more than three decades, with the goal of creating a healthier world for all people. The company is committed to promoting innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Gilead acquired Kite in 2017.

Gilead’s Forward-Looking Statements

This press release includes forward-looking statements pursuant to the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the ability of the companies to enter into contemplated transactions pursuant to and as a result of the timely review agreement or altogether, including the transfer of the marketing authorization for Yescarta in Japan to Gilead Sciences KK and the manufacturing and supply of Yescarta in Japan; the risk that Gilead and Kite will not realize the expected benefits of the revised agreement with Daiichi Sankyo; unforeseen difficulties or expenses in connection with the implementation of the revised agreement; the potential effect on Gilead and Kite’s earnings; and any assumptions underlying the foregoing. These and other risks, uncertainties and other factors are detailed in Gilead’s quarterly report on Form 10-Q for the quarter ended September 30, 2022, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those indicated in the forward-looking statements. All statements other than statements of historical fact are statements that could be considered forward-looking statements. The reader is cautioned that such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and is cautioned not to place undue reliance on such forward-looking statements. All forward-looking statements are based on information currently available for Gilead and Kite, and Gilead and Kite assumes no obligation and disclaims any intent to update such forward-looking statements.

US prescribing information for Yescarta included ATTENTION BOXEDis available on www.kitepharma.com And www.gilead.com.

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

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1 The approved indication in Japan is the treatment of relapsed or refractory diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, transformed follicular lymphoma or high-grade B-cell lymphoma, in patients who: i) do not have been previously treated with an infusion of CAR-positive CD19 T cells; and, ii) have previously been treated with two or more lines of treatment, including chemotherapy or an autologous stem cell transplant, or are ineligible for an autologous stem cell transplant.

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

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Written by Natalia Chi

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