On April 9, 2018 Otsuka Pharmaceutical Co., Ltd. reported that it has entered into an agreement with Takara Bio for co-development and exclusive sales rights in Japan for Takara’s NY-ESO-1 siTCRTM (TBI-1301, TBI-1301-A) and CD19 CAR (TBI-1501), both gene therapy products in development for cancer applications (Press release, Takara Holdings, APR 9, 2018, View Source [SID1234591489]).
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Under the agreement, the companies will aim for early regulatory approval for the manufacture and sale of the two therapeutic products in Japan. Takara Bio will be responsible for manufacturing and quality control of the two investigational products, while Otsuka will be responsible for clinical trials, other clinical studies, regulatory submissions, product sales and safety data collection. There are no limitations on the target indications in the agreement. Otsuka also holds a right of first refusal for nine Asian countries outside Japan.
Takara Bio will receive upfront and milestone payments from Otsuka, dependent upon the achievement of specified development targets. Takara Bio will supply Otsuka with the products based on specified financial terms. For the NY-ESO-1 siTCRTM gene therapy product, Takara Bio will receive milestone payments upon the achievement of target sales in addition to a running royalty on net sales. The upfront and milestone payments will be up to a maximum total amount of approximately 6.3 billion yen.
Toshiki Sudo, executive director, Research and Otsuka board member noted that, "We are striving to develop innovative products that contribute to the health of humankind around the world, a part of which is co-development cooperation with Takara Bio. We know from our collaboration with Takara Bio on their oncolytic virus HF10 that they have highly advanced biotechnologies and manufacturing facilities dedicated to cell therapy. We aspire jointly to advance biologics research including gene and cell therapy to satisfy currently unsatisfied medical needs."
Masanobu Kimura, Takara Bio board member and president of the Gene Therapy Business Unit, commented that the collaboration with Otsuka, which has broad experience in clinical development, pharmaceutical affairs and sales of pharmaceutical products, will contribute to the development, commercialization and value maximization of the therapeutic products. "We are convinced of further progress on the effective development, aided by the designation of NY-ESO-1・siTCRTM gene therapy product under "SAKIGAKE Designation System" (prioritized review) by the Japanese Ministry of Health, Labour and Welfare on March 27, 2018."
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