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FUJIFILM Toyama Chemical signs Licensing Agreement for Development and Commercialization of Novel Small Molecule Compound FF-10158 for Oncology Indications both in diagnostics and therapeutics
December 3, 2018
FUJIFILM Toyama Chemical Co., Ltd.

FUJIFILM Toyama Chemical Co., Ltd. (Headquarters: Tokyo / President: Junji Okada) today announced it has signed a licensing agreement, on November 27, for the development and commercialization of a novel small molecule compound FF-10158 for oncology indications both in diagnostics and therapeutics outside of Japan with Advanced Accelerator Applications (AAA), a Novartis company and a leader in nuclear medicine. FUJIFILM Toyama Chemical will receive an upfront payment with the signing of the agreement, as well as future milestones and royalties from AAA.

FF-10158 was created using the chemical synthesis and compound design capabilities cultivated through wide range of product development of FUJIFILM Corporation and combined with the knowhow of FUJIFILM Toyama Chemical, specialists in the development of radiopharmaceuticals, and it has been confirmed to be stably labeled with radioisotopes. FF-10158 targets integrin*1, which appears with high frequency in many malignant tumors such as malignant gliomas.*2. It is expected that FF-10158 will have applications for both diagnostic and therapeutic drugs.

FUJIFILM Toyama Chemical has developed FF-10158 with the support of the Japan Agency for Medical Research and Development (AMED), through its “Support Program for Orphan drug prior to the Designation” aimed at accelerating the development of orphan drugs and enabling the practical application of orphan drugs promptly and effectively (Project Number: JP17nk0101207 & JP18nk0101216). In animal models, the tumor accumulation of FF-10158 was observed and FF-10158 suggested potential as a theragnostic*3 agent that can be applied to both the diagnosis and treatment of tumors by changing the radioisotope.

Advanced Accelerator Applications, a Novartis company, is an innovative radiopharmaceutical company developing, producing and commercializing radioligand theragnostics (pairings of therapeutic and diagnostic drugs based on the same targeting molecule) for oncology. AAA is an established leader in radiopharmaceuticals for Positron Emission Tomography (PET) and Single-Photon Emission Computed Tomography (SPECT) diagnostic imaging, mainly used in clinical oncology, cardiology and neurology.

With the signing of this agreement, FUJIFILM Toyama Chemical will grant AAA the rights to develop and commercialize FF-10158 worldwide with the exception of Japan.

FUJIFILM Toyama Chemical will move forward with preparations for the start of clinical studies in Japan investigating FF-10158 in malignant gliomas such as glioblastoma.

FUJIFILM Toyama Chemical will accelerate the development of new diagnostic and therapeutic drugs and expand its offering of total solutions from diagnosis to treatment, contributing to the further advancement of medicine.

* 1 Integrin is a protein found on the surface of cells and is one of the cell adhesion molecules.

* 2 Malignant gliomas are a type of brain tumor that develop from the glial cells that support the nerve cells of the brain. Among malignant gliomas, glioblastomas have a particularly high malignancy, and is a disease with high unmet medical needs. Currently, surgery, radiation therapy, and chemotherapy are conducted as standard treatment, but there is a strong demand for more effective treatment methods as the five-year survival rate is low at approximately 10%. (Stupp R, et al. Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study: 5-year analysis of the EORTC-NCIC trial. Lancet Oncol. 2009, 10, 459)

* 3 Theragnostics is a term coined by combining treatment or “therapeutics” with diagnosis or “diagnostics”, and refers to the concept or method of conducting diagnosis and treatment using the same or similar compounds. In the area of nuclear medicine, it is possible to use a compound labeled with an imaging radioisotope to first localize the lesion(s) by imaging, then label the same compound with a therapeutic radioisotope for treatment.


About FUJIFILM Toyama Chemical

FUJIFILM Toyama Chemical was launched by merging FUJIFILM RI Pharma Co., Ltd., a company that conducts the research, development, manufacture, and sales of radiopharmaceuticals, and TOYAMA CHEMICAL CO., LTD., a company that conducts the research, development, manufacture, and sales of small molecule pharmaceutical products. FUJIFILM Toyama Chemical dedicates efforts to developing innovative diagnostic and therapeutic radiopharmaceuticals and therapeutic drugs with unique mechanisms of action in the fields of “oncology”, “central nervous system diseases”, and “infectious diseases” where significant unmet medical needs still exist, with close collaboration with FUJIFILM Corporation which focuses on research of new medicines. It will also advance the development of new medicines utilizing drug delivery system (DDS) technologies that timely deliver the required amount of a drug to the specific body area. Also, by exploring synergy with in vitro diagnostic (IVD) devices and reagents owned by Fujifilm group companies, the company will expand its offering of comprehensive solutions from “diagnosis” to “treatment”.

For more information of FUJIFILM Toyama Chemical, please visit http://fftc.fujifilm.co.jp/en/

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