FUJIFILM : New manufacturing facility to be built at Toyama Chemical, a Fujifilm company.

February 22, 2018

FUJIFILM Corporation (President: Kenji Sukeno) will invest approximately 4 billion yen in the pharmaceutical production site of its group company, Toyama Chemical Co., Ltd. (President: Junji Okada), to build a new manufacturing facility. At the facility, the company plans to manufacture liposome drugs utilizing proprietary technologies such as its anti-cancer agent FF-10832 for the use of clinical trials and commercial marketing. Construction of the new facility will begin in September 2018, and the facility is scheduled to begin operations in February 2020.

Liposome drugs contain drugs in artificially constructed vesicles made from the same organic phospholipids that make up cell and bio membranes. Currently, Fujifilm is harnessing its advanced nano-dispersion technology, analysis technology, and process technology cultivated through the photographic film business to promote the research and development of liposome drugs that efficiently deliver drugs to the affected area and enhance efficacy. In particular, with its anti-cancer agent FF-10832, which encapsulates a marketed drug *in liposomes with a uniform size of approximately 80nm, the experiments on mice demonstrated increased stability of the agent within the blood, increased concentration of the agent within the tumor, and facilitating its release in the tumor, and a pharmacological benefit exceeded significantly compared to the marketed drug *not formulated with liposome when FF-10832 was administered at a lower dose amounting to 1/60th of the marketed drug. The company is working towards the start of Phase I clinical trials in the U.S. this year. The company is also conducting research and development aiming for the early start of clinical trials on liposome drugs other than FF-10832.

The new facility will manufacture liposome drugs in compliance with Japan/U.S./Europe GMP**standards. The facility will enable the stable production of highly reliable, high quality liposome drugs through the adoption of manufacturing equipment originally designed and developed using Fujifilm's advanced production technologies and the installation of high containment facilities as well as the use of know-how of Toyama Chemical cultivated in the sterile production of injectable formulations. The facility will also feature advanced production systems using cutting-edge ICT technologies. This will enable the centralized control of the manufacturing process, quality assessment data, and facility operation data, as well as the control of use of raw materials and parts through electronic tags, to achieve efficient production operations.
The new facility will manufacture liposome drugs such as FF-10832 for use in the clinical studies and commercial marketing, ensuring the stable supply of high quality liposome drugs.

Fujifilm is engaged in the development of new drugs, defining oncology, central nervous system diseases, and infectious diseases as its focal areas, making use of the advanced technologies cultivated in the photographic film business such as the synthesis and design of compounds and nano-dispersion technology. The company is also promoting the development of drug delivery system (DDS) technologies that deliver the required amount of a drug to the specific area on the necessary schedule. With the aim of applying the technologies not only to marketed drugs but expanding to next-generation drugs such as nucleic acid drugs and gene therapy drugs, the company is undertaking the research and development of DDS. Going forward, the company will contribute to the resolution of social issues through the provision of innovative and high value-added pharmaceutical products.

• *An anti-cancer drug (generic name: gemcitabine, product name: Gemzar) developed by the U.S. company Eli Lilly and Company. It is used as a drug of first choice for the treatment of pancreatic cancer, and is also indicated for the treatment of a wide range of other cancers (such as lung cancer and ovarian cancer).
• **Good Manufacturing Practice: Stipulates manufacturing and quality control to supply good quality pharmaceutical products and medical devices.

[ Overview of the New facility ]

[ Exterior of the New Facility (Illustration) ]

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