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Submission of a New Drug Application of T-3811, an Oral New-Type Quinolone Antibiotic agent, in Japan
|May 31, 2006|
Toyama Chemical Co., Ltd. ("Toyama"; headquarters: Shinjuku-ku, Tokyo; president and CEO: Katsuhiko Nakano) submitted a New Drug Application to the Japan Ministry of Health, Labor and Welfare on May 30, for oral formulations of its new-type quinolone antibiotic agent T-3811 (generic name: garenoxacin).
Profile of T-3811
In Japan, Toyama and Taisho Pharmaceutical Co., Ltd. ("Taisho"; headquarters: Toshima-ku, Tokyo; President: Akira Uehara) has co-developed T-3811 for the treatment for respiratory infections and otolaryngologic infections as the target indications.
And, in March this year, Toyama and Astellas Pharma Inc. ("Astellas"; headquarters: Chuo-ku, Tokyo; President and CEO: Toichi Takenaka) concluded a basic licensing agreement for the marketing and joint development of T-3811 in Japan. Taisho Toyama Pharmaceutical Co., Ltd., ("Taisho Toyama"; headquarters: Toshima-ku, Tokyo; President: Akira Ohira) and Astellas will co-promote T-3811 under the same brand name. Astellas will distribute and sell T-3811.
Toyama has granted to Schering-Plough Corporation exclusive rights to develop, use and sell T-3811 worldwide, excluding Japan, Korea and China. A new drug application (NDA) has been accepted for review by the US Food and Drug Administration (FDA) in February this year. In Europe, a marketing authorization application (MAA) will be filed with the European Medicines Agency (EMEA) by the end of this year.
Once T-3811 is approved in Japan, the related companies, Toyama, Taisho, Taisho Toyama and Astellas will cooperate with each other in order to maximize the product potential in the domestic market.