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Application for manufacturing and sales approval in Japan filed for T-4288, an antibacterial agent
|April 25, 2019|
|FUJIFILM Toyama Chemical Co., Ltd.|
Tokyo, April 25, 2019 ― FUJIFILM Toyama Chemical Co., Ltd. (Headquaters: Tokyo; President: Junji Okada) hereby announces that it has submitted to Japan’s Ministry of Health, Labour and Welfare, an application for manufacturing and marketing approval for an antibacterial agent T-4288 (generic name: solithromycin) as a treatment for infectious diseases in otorhinolaryngology, diseases of the ear, nose and throat.
With the threat of antimicrobial resistance growing as a global health concern, there is an urgent need to develop new antibiotics capable of combating drug resistance. T-4288 is a fluoro-ketolide antibacterial agent* that demonstrates powerful antimicrobial activity against pathogenic bacteria including penicillin- or macrolide-resistant pneumococcus. The agent has high-level tissue migration capabilities, and demonstrates immunoregulatory activity (anti-inflammatory activity).
In 2013, FUJIFILM Toyama Chemical obtained, from Cempra Pharmaceuticals, Inc. (presently Melinta Therapeutics, Inc.), the exclusive right to develop, manufacture and market T-4288 in Japan, and has since been conducting clinical studies domestically with the patients of infectious diseases in otorhinolaryngological such as mainly otitis media and sinusitis, and respiratory such as community-acquired pneumonia. In 2016, the company began implementing Phase III clinical trials, and observed the efficacy and safety for T-4288 in patients with infections in the otorhinolaryngological areas. Accordingly, the company has applied for its manufacturing and marketing approval as a treatment drug for infectious diseases in otolaryngology. Development activities targeting patients with respiratory infectious diseases are ongoing.
FUJIFILM Toyama Chemical will add this fluoro-ketolide antibacterial agent to its existing range of penicillin-, cephem- and quinolone-type antibacterial drugs to further enhance its lineup in the field of infectious diseases, contributing to the further advancement of medicine through the development, manufacture and sale of high value-added pharmaceutical products.
*Fluoro-ketolide antibacterial agent demonstrates antimicrobial activity by inhibiting the protein synthesis in bacteria like macrolide antibacterial drugs. Macrolides are known to bind to one site of bacterial ribosomal RNA, while T-4288 binds to three sites. T-4288 which possesses fluoride in its chemical structure is a new type antibacterial agent.
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/