Kite Announces Completion of Marketing Authorization Transfer for Yescarta® CAR T-cell Therapy in Japan

SANTA MONICA, Calif.--(BUSINESS WIRE)-- Kite Pharma, Inc., a Gilead Company (Nasdaq: GILD), today announced that the Marketing Authorization in Japan for Yescarta^® (axicabtagene ciloleucel), a chimeric antigen receptor (CAR) T-cell therapy, has been transferred from Daiichi Sankyo Co., Ltd. to Gilead Sciences K.K., the Japan subsidiary of Gilead Sciences, Inc.

This follows the announcement made by Daiichi Sankyo and Kite Pharma, Inc. in December 2022 about changes to their initial 2017 partnership whereby Daiichi Sankyo obtained the Marketing Authorization for Yescarta^®. With this completion of the Marketing Authorization transfer, the sales and promotion activities of Yescarta^® in Japan now will be managed by the Kite Cell Therapy Business Unit of Gilead Sciences K.K.

“As the global leader in cell therapy, we appreciate the opportunity and responsibility of bringing this innovative treatment to as many eligible patients as possible who may benefit,” said Cindy Perettie, Executive Vice President and Global Head of Kite. “We are pleased that we are able to fully leverage our manufacturing expertise and commercialization capabilities to meet increasing demand and maximize the potential of this important therapy for patients in Japan.”

The first Yescarta^® treatment center in Japan was authorized in December 2021, and there are now a total of six hospitals in Japan authorized to administer the therapy with many more anticipated by the end of the year. 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 commenced its supply of the product earlier this year.

“We are rapidly building a diverse pipeline in oncology, from antibody-drug conjugates and small molecules to cell therapy-based approaches,” said Kennet Brysting, General Manager of Gilead Sciences K.K. “We look forward to advancing new treatments in oncology with the potential to positively impact the lives of people with cancer in Japan.”

About YESCARTA^®

Yescarta^® (axicabtagene ciloleucel) is a CAR T-cell therapy directed against CD19 (a cell membrane protein), which harnesses a patient’s own immune system to fight cancer. Axicabtagene ciloleucel is made by removing a patient’s T cells from their blood and engineering them in the lab to express chimeric antigen receptors so that they can recognize and destroy cancer cells when they are infused back into the patient’s body. The CAR T-cell therapy is manufactured specifically for each patient and administered only once.

Axicabtagene ciloleucel received Orphan Drug Designation from the Japan Ministry of Health, Labour, and Welfare in 2018 for the treatment of diffuse large B-cell lymphoma (LBCL), primary mediastinal B-cell lymphoma, transformed follicular lymphoma and high-grade B-cell lymphoma. Yescarta was approved in Japan for the treatment of patients with relapsed or refractory (R/R) large B-cell lymphomas, a type of non-Hodgkin lymphoma, who are previously treated with two or more lines of treatment including chemotherapy or an autologous stem cell transplant, in January 2021. In December 2022, Yescarta was approved for the initial treatment of patients with R/R LBCL in Japan.

Yescarta is approved in more than 20 countries, including the U.S., Canada, Europe, Great Britain, Switzerland, Brazil, Singapore, Israel, Japan, and Australia, for patients with certain types of relapsed or refractory B-cell lymphoma. It is developed and manufactured by Kite and commercialized by Kite in the U.S. and outside the U.S. by the respective Gilead affiliate.

Please see full U.S. Prescribing Information, including BOXED WARNING and Medication Guide.

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

• Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses 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 (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.

Limitations of Use: Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma. (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 trial(s). (1.2)

For the 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 based in Santa Monica, California, focused on cell therapy to treat and potentially cure cancer. As the global cell therapy leader, 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, spanning process development, vector manufacturing, clinical trial supply and commercial product manufacturing. For more information on Kite, please visit www.kitepharma.com.

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing 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 Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead and Kite’s ability to effectively manage the global manufacturing and commercialization activities of Yescarta, including the sales and promotion activities of Yescarta in Japan; the risk that Gilead and Kite may not realize the anticipated benefits of the revised arrangement with Daiichi Sankyo; difficulties or unanticipated expenses in connection with implementing the revised arrangement and the potential effect on Gilead and Kite’s earnings; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and other factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, 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 referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is 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 intent to update any such forward-looking statements.

U.S. Prescribing Information for Yescarta, including BOXED WARNING, is available at www.kitepharma.comand www.gilead.com.

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