FUJIFILM Holdings Corp : Fujifilm initiates Phase I clinical trial in Japan for the anticancer agent "FF-10501" in patients with relapsed or refractory myelodysplastic syndromes.

June 6, 2013

FUJIFILM Corporation (President: Shigehiro Nakajima) has initiated Phase I clinical trial for the anticancer agent "FF-10501" in patients with relapsed or refractory myelodysplastic syndromes (MDS) in Japan.

MDS is a type of hematological malignancies, in which hematopoietic stem cells have disorders to produce sufficient normal blood cells, triggering cytopenias. It is also a refractory disease for some patients with poor prognosis, progressing to acute myeloid leukemia. Currently, MDS patients in Japan are estimated to be around 10,000, many of them in the senior age group.

In 2008, Fujifilm entered into the pharmaceutical business upon acquisition of Toyama Chemical. The company has since established an internal unit for researching and developing new candidate drugs in a drive to create innovative pharmaceutical products. FF-10501 is the first internally-developed drug candidate to undergo clinical trial. Tapping into the advanced ability to synthesize and design chemical compounds, nurtured through the development of photographic films, the company has enhanced the drug's stability and applied strong analysis technology to elucidate new mechanisms of action and identify biomarkers for verifying its efficacy.
FF-10501 is expected to not only inhibit the growth of hematological cancer cells but also promote their differentiation to cells with normal functions. While most of the MDS therapies available today are injections, FF-10501 is orally available, thereby improving the QoL of senior-aged patients who represent a large proportion of the MDS population.

Fujifilm is working on the R&D of innovative pharmaceutical products and creation of their production processes by amassing and integrating its affiliates'*technologies with its own technologies and know-how nurtured through photographic film business, including chemical synthesizing / design capacity, analytical skills, nanotechnology and production technologies. Defining "oncology", a field with numerous unmet medical needs, as its focal area, the company will actively promote R&D to expand the business operation and supply innovative pharmaceutical products so as to contribute to the development of medical care around the world.

• *Applicable affiliates include Toyama Chemical (a leading company in infectious disease treatments) in the field of low-molecular pharmaceuticals, as well as FUJIFILM RI Pharma (developing and marketing radiopharmaceuticals), Perseus Proteomics (conducting drug discovery research for antibody pharmaceuticals) and FUJIFILM Diosynth Biotechnologies UK/USA (producing biopharmaceuticals) in the field of biopharmaceuticals.