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ANNOUNCEMENT ON THE START OF PATIENT ENROLLMENT FOR PHASE III CLINICAL STUDY IN JAPAN OF THE ANTIVIRAL DRUG FAVIPIRAVIR FOR IXODID TICK-BORNE INFECTIOUS DISEASE, SERIOUS FEVER WITH THROMBOCYTOPENIA SYNDROME (SFTS) - FUJIFILM Pharmaceuticals USA

ANNOUNCEMENT ON THE START OF PATIENT ENROLLMENT FOR PHASE III CLINICAL STUDY IN JAPAN OF THE ANTIVIRAL DRUG FAVIPIRAVIR FOR IXODID TICK-BORNE INFECTIOUS DISEASE, SERIOUS FEVER WITH THROMBOCYTOPENIA SYNDROME (SFTS)

Toyama Chemical Co., Ltd. (Head Office: Shinjuku-ku, Tokyo; President: Junji Okada), a FUJIFILM Company, has announced that it has started to enroll patients for phase III clinical study in Japan of the antiviral drug favipiravir for ixodid tick-borne infectious disease, serious fever with thrombocytopenia syndrome (SFTS).

Favipiravir is a drug that has already obtained marketing authorization as an anti-influenza virus drug called “AVIGAN® Tablet” which has a mechanism of action to prevent viral proliferation by selectively inhibiting the RNA polymerase of the influenza virus. Because of this characteristic of the drug, it is expected that favipiravir can be applied to other areas of viral infections in addition to the influenza virus. Basic research using animal models conducted at the National Institute of Infectious Diseases (NIID) has confirmed the efficacy of favipiravir in SFTS. In addition, the results of the clinical research* of favipiravir, conducted from June 2016 by Ehime University, Nagasaki University, and NIID as pivotal organizers for SFTS, was reported that the research produced new findings that will lead to the development of an effective treatment method.

Toyama Chemical has now started to enroll patients in a domestic phase III clinical study of the antiviral drug favipiravir for SFTS. The company will aim to develop and provide a new treatment method for SFTS, for which only supportive therapy is currently available.

Toyama Chemical, a subsidiary of FUJIFILM Holdings Corporation, specializes in pharmaceutical research and development, and strives to contribute to the further development of global health care through new drug development.

* A clinical research which was adopted and conducted by the Research Program on Emerging and Re-emerging Infectious Diseases (Title of research and development: “Research on the diagnostic, therapeutic, and preventive measures’ development for and on the infection risk factors’ analyses on severe fever with thrombocytopenia syndrome.”) of the Japan Agency for Medical Research and Development (AMED).

About favipiravir (brand name: AVIGAN® Tablet):

Favipiravir, developed by Toyama Chemical, obtained approval in March 2014 as a drug which will be under consideration for administration to patients when a new or re-emergent influenza virus infection occurs in Japan for which other anti-influenza virus drugs are not responsive or are not sufficiently effective, and the government determines to use this drug against the virus.

About severe fever with thrombocytopenia syndrome (SFTS):

SFTS is thought to occur when a person is bitten by an ixodid tick that carries the SFTS virus. The patient develops SFTS through an incubation period of about 6 days to 2 weeks after being infected with the virus. In serious cases, neurological symptoms, bleeding, multi organ failure, etc. occur. In Japan, a total of 318 patients have been confirmed as of January 31, 2018 and, of those, 60 died. SFTS has been reported mostly in Western Japan and a risk of being affected with SFTS increases from spring to fall when ixodid ticks become active. Although it is very rare, there are reports of patients who were infected with SFTS by infected dogs or cats.

For inquiries on information in this media release, contact:
General Affairs Group, General Affairs and Personnel Department, Toyama Chemical Co., Ltd.
FAX: +81-3-3348-6638

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