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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.

Schering-Plough Reports Garenoxacin (T-3811) NDA accepted for FDA review
February 13, 2006.

February 13, 2006, Tokyo; Toyama Chemical Co., Ltd. (President and CEO: Katsuhiko Nakano) announced today that the U.S. Food and Drug Administration has accepted for review its New Drug Application (NDA) for garenoxacin submitted in the U.S. by Schering-Plough Corporation (Chairman and CEO: Fred Hassan). Schering-Plough plans to file a similar new drug application for garenoxacin with the European Medicines Agency (EMEA) this year.

T-3811 (generic name: garenoxacin) is a new-type quinolone antibacterial agent discovered by Toyama Chemical. Toyama Chemical and Schering Plough entered into a license agreement to develop, use and sell garenoxacin worldwide except Japan, South Korea and China in June, 2004.

Different from conventional quinolone antibiotics, T-3811 (garenoxacin) is a new type of quinolone antibacterial agent with no fluorine atom at position 6 of the quinolone skeleton. T-3811 has a broad spectrum of activity, especially against resistant strains of Gram positive organisms such as MDRSP (Multi Drug Resistant Streptococcus Pnemonia) and MRSA (Methicillin-Resistant Staphylococcus Aureus), which are growing concerns in the medical community.

In clinical studies carried out abroad, the efficacy of T-3811 has been confirmed in a wide range of infections from respiratory tract infections to surgical infections and T-3811 shows a good safety profile compared to the comparative drugs. T-3811 is expected to contribute to performance of Toyama Chemical greatly after its launch.

In Japan, all clinical studies necessary to file a new drug application in Japan have been completed, and Toyama Chemical is currently preparing for its submission in the 1st half of this year.

Profile of Schering-Plough Corporation

Company name : Schering-Plough Corporation
Representative : Fred Hassan (Chairman and CEO)
Number of employees : Approximately 30,500
Net sales : US$9.5 billion (2005)
Business : Manufacture and sales of OTC and ethical drugs for human and animal health. Global pharmaceutical company in the fields of allergy/inflammation, infectious disease, oncology, cardiovascular, and CNS disorders
Headquarters : 2000 Galloping Hill Road, Kenilworth, N.J. 07033-0530 USA
Fiscal year-end : December
Website : http://www.schering-plough.com/schering_plough/index.jsp
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