Otsuka Pharmaceutical has entered an agreement with Takara Bio for the co-development and exclusive sales rights in Japan for two of Takara’s gene therapy products.
Takara will receive upfront and milestone payments from Otsuka of up to JPY6.3bn , dependent on the achievement of specified development targets.
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The two products, NY-ESO-1 siTCR and CD19 CAR, are being developed for cancer applications. NY-ESO-1 siTCRTM has been granted priority review, or ‘Sakigage’ status, by the Japanese Ministry of Health, Labour and Welfare for the treatment of synoviral sarcoma, a rare form of cancer which occurs primarily in the arms or legs. CD19 is a chimeric antigen receptor T-cell therapy for acute lymphoblastic leukaemia, a type of cancer that affects the white blood cells.
Under the agreement, the companies will aim for early regulatory approval for the manufacture and sale of the two therapeutic products in Japan. Takara will be responsible for the manufacture 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.
Otsuka also holds a right of first refusal─meaning Otsuka has the right to enter a business transaction with Takara before Takara can enter into that transaction with a third party─for nine other countries in Asia.
Otsuka executive director of research and board member Toshiki Sudo said: “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.
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By GlobalData“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.”
Otsuka has collaborated with a number of other pharmaceutical companies including Bristol-Myers Squibb for the commercialisation of a treatment for chronic myeloid leukemia, and Teva for exclusive rights for developing and marketing fremanezumab in Japan.
