Otsuka Pharmaceutical Co., Ltd.

November 10, 2022

Announcement of Termination of Co-Development and Exclusive Marketing
Agreements with Takara Bio for NY-ESO-1・siTCR® gene therapy candidate

Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that it has decided jointly with Takara Bio Inc, (Takara Bio) to terminate agreements on co-development and exclusive marketing of NY-ESO-1・siTCR® gene therapy product (development code: TBI-1301).

Otsuka and Takara Bio have been jointly developing NY-ESO-1・siTCR® 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, Otsuka and Takara Bio have agreed to terminate this agreement. This decision is not due to any efficacy or safety issues of the product.

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.

News releases below on original agreements with Takara Bio
  • Otsuka enters agreement with Takara Bio for co-development and sales rights in Japan to NY-ESO-1 siTCR and CD19 CAR gene therapies

  • Designation Description Change of NY-ESO-1・siTCR gene therapy product under "SAKIGAKE Designation System"

  • Clinical program for NY-ESO-1/siTCR gene therapy candidate receives designation in Japan as Orphan Regenerative Medicine