Announcement of Termination of Co-Development and Exclusive Marketing Agreements with Otsuka Pharmaceutical Co., Ltd. for NY-ESO-1・siTCR™ gene therapy candidate

On November 10, 2022 –Takara Bio Inc. (Takara Bio), reported that it has decided jointly with Otsuka Pharmaceutical Co., Ltd. (Otsuka), to terminate agreements on co-development and exclusive marketing of NY-ESO-1・siTCRTM gene therapy product (development code: TBI-1301) (Press release, Takara Holdings, NOV 10, 2022, View Source [SID1234635875]).

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　1.　Reasons for the termination

Takara Bio and Otsuka have been jointly developing NY-ESO-1・siTCRTM gene therapy for synovial sarcoma in Japan and preparing for the submission for manufacturing and marketing approval. However after comprehensive discussions between the two companies on policies and strategies related to this product, Takara Bio and Otsuka have agreed to terminate this agreement. This decision is not due to any efficacy or safety issues of the product.

　2.　Details of the termination agreement

Under this termination, Takara Bio regains technical, intellectual property and other rights granted by Takara Bio to Otsuka. In addition, in the future Takara Bio will not receive lump-sum payments upon achievement of milestones under this agreement or receive any sales proceeds for clinical trial product sales.

　3.　Overview of the other party to terminate this agreement

[1] Company name

Otsuka Pharmaceutical Co., Ltd.

[2] Head office

2-9, Kanda-Tsukasamachi, Chiyoda-ku, Tokyo 101-8535, Japan

[3] URL

View Source

　4.　Schedule

Corporate resolution, date of the termination agreement: November 10, 2022

　5.　Future Outlook

The impact of the termination of these agreements on the consolidated financial results of the Company for the fiscal year ending March, 2023 will be minor.