Vol.52 No.12 December 2004
Status and prospects for antibacterial agent development
Japan Antibiotics Research Association,
2-20-8 Kamiosaki, Shinagawa-ku, Tokyo, Japan
Abstract
In the 58 years since penicillin was clinically introduced, 238 antibacterial agents have been used in Japan. Through the alternation of generation and selection, 154 are available today. The majority of current agents are 65 β -lactams and 24 synthetic chemotherapeutics including fluoroquinolones.
Taking a general view of approval of antibacterial agents during the last 2 decades, 46 of different classes were approved in the first decade but only 19 of limited classes in the second. Such low activity suggests the need to develop novel antibacterial agents with potential for coping with the alteration of infectious diseases within 5-10 years.
Current development of medicinal products including antibacterial agents is conducted globally, simultaneously, and cooperatively. Novel agents created in Japan are often evaluated simultaneously in clinics in Japan, the US and Europe. Unlike Japan, however, the approval of agents in the US in last 10 years is recognized to be preferred to those possessing activity against defined resistant bacteria and being applied to a narrow spectrum of infectious diseases. Philosophies on development of antibacterial agents differ in Japan and the west, i.e., carbapenems and fluoroquinolones dominate over those under development in Japan, while glycopeptide, rifamycin, and others are extensively developed in the US and Europe.
Industries involved in the development of antibacterial agents also differ, i.e., are limited to megapharma firms in Japan but, in the US, small industries called biopharma are creating novel agents with novel mechanism of action under unique approaches. The US megapharm firms may take them to clinical development when they have completed their preliminary evaluation. Such novel agents have been evaluated at ICAAC annual meetings sponsored by the American Society for Microbiology, and a great deal of information the trends in development of antibacterial agents is available at the conference.
Key word
antibacterial agent, development, approval
Received
November 1, 2004
Accepted
November 25, 2004
Jpn. J. Chemother. 52 (12): 761-770, 2004
