Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals
November 9, 2021

Announcement of Termination of Co-Development and Exclusive Marketing Agreements with
Takara Bio for Oncolytic virus HF10 and CD19-Targeted CAR Gene Therapies

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 the drug candidates oncolytic virus HF10 (development code: TBI-1401, INN: canerpaturev) and CD19-targeted CAR gene therapies (development code: TBI-1501).

Otsuka and Takara Bio will continue to co-develop NY-ESO-1・siTCRTM gene therapy product (development code: TBI-1301).

  

  1. 1. Reasons for the termination

Oncolytic virus HF10

Both Takara Bio and Otsuka have discussed development plans for pancreatic cancer and other malignancies after the Phase I clinical trial for pancreatic cancer, however, in consideration of the time required for future development and other factors, two companies have decided to terminate the agreement.

CD19-targeted CAR gene therapies

Both companies have been conducting a Phase I/II trial for adult acute lymphoblastic leukemia, however, in consideration of the lengthy period for clinical development and the competitive landscape, the two companies have decided to terminate the agreement.

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.

<News releases below on original agreements with Takara Bio>

Otsuka Signs Japan-Exclusive License Agreement with Takara Bio for the Investigational Cancer Treatment HF10, an Oncolytic Virus

https://www.otsuka.co.jp/en/company/newsreleases/2016/20161215_1.html

Otsuka enters agreement with Takara Bio for co-development and sales rights in Japan to NY-ESO-1 siTCRTM and CD19 CAR gene therapies

https://www.otsuka.co.jp/en/company/newsreleases/2018/20180409_1.html