Otsuka Pharmaceutical Co., Ltd.

December 15, 2016

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

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Takara Bio Inc. (Takara Bio) entered into an exclusive license agreement on December 15 for the joint development and commercialization in Japan of Takara's investigational oncolytic virus HF10 therapy (HF10) for the treatment of pancreatic cancer, melanoma and other tumors.

HF10 is an attenuated strain of Herpes Simplex Virus type 1 (HSV-1) *1, an oncolytic virus which in clinical trials to date has demonstrated antitumor activity when injected into cancerous areas. Oncolytic viruses, which rarely proliferate in normal cells, destroy cancer cells directly by proliferating inside them.

Under the terms of the agreement, Otsuka and Takara Bio are to jointly pursue remaining clinical development of HF10 in Japan. Otsuka is to pay Takara Bio an up-front milestone payment and development progression milestone payments (up to approximately 3 billion yen).

Otsuka is to hold exclusive commercialization rights in Japan. Related to this, Otsuka is to make up to two milestone payments to Takara Bio based on the attainment of specified sales targets.

Takara Bio is to manufacture the product for use in clinical trials and for post-approval supply in return for unspecified fees to be paid by Otsuka.

Assuming HF10 receives regulatory approvals, the aim is launch HF10 in Japan as an oncolytic virotherapy for melanoma, pancreatic cancer and other tumors.

  1. 1HF10 is a spontaneously occurring mutant of HSV-1 that does not contain any foreign genes. Live viruses such as HSV infect human cells, replicate, and destroy the infected cells. Oncolytic viruses use this approach to kill tumorous cells and do so without excessively damaging normal tissue. Administration of HF10 also induces a strong immune response which is expected to further enhance anti-tumor activity.