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The information in news releases is current at the time of the release. Note that the information shown here may not be latest information (termination of production or sales, changes to specifications or pricing, organizational or contact address changes, etc.), and may be subject to change without prior notice.

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

Different from conventional quinolone antibiotics, it is a new type of quinolone with no fluorine atom at position-6 of the quinolone skeleton.
It has a wide antibacterial spectrum and is also effective against problematic resistant bacterial strains such as PRSP (penicillin-resistant Streptococcus pneumoniae) and MRSA (methicillin-resistant Staphylococcus aureus).
It shows good oral absorption and tissues distribution, which makes once a day oral administration possible.

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.

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