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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.

Otsuka Pharmaceutical granted domestic sell rights to TN-3262a antibacterial eye drops, currently under joint development by Toyama Chemical and Nidek

March 25, 2003

Summary

Toyama Chemical Co., Ltd. (head office: Shinjuku-ku, Tokyo; President: Katsuhiko Nakano), Nidek Co., Ltd. (head office: Gamagori-shi, Aichi Prefecture; President: Hideo Ozawa), and Otsuka Pharmaceutical (head office: Chiyoda-ku, Tokyo; President: Tatsuo Higuchi) have reached agreement on granting Otsuka Pharmaceutical Japanese sell rights to the new quinolone synthetic antibacterial eye drops TN-3262a (generic name: tosufloxacin tosilate), which is currently under joint development by Toyama Chemical and Nidek. The three companies executed a licensing agreement on March 18, 2003.

Under this agreement, both Nidek and Otsuka Pharmaceutical have domestic sell rights to this product.

Tosufloxacin tosilate was originated by Toyama Chemical and launched in 1990 as the oral quinolone synthetic antibacterial Ozex Tablets. The compound is currently under development for use as eye drops.

Based on licensing and joint development contracts agreed in 1998 between Toyama Chemical and Nidek, TN-3262a is under joint development by the two companies (currently at Phase 3) with the objective of filing for approval in 2004.

Otsuka Pharmaceutical already has a track record in ophthalmology sales and aims to strengthen its ophthalmology pipeline further. Japanese sell rights were originally granted to Nidek, but by also granting sell rights to Otsuka Pharmaceutical, Toyama Chemical expects to achieve more rapid market penetration through post-launch sales activities by both companies.

Importance of the development of TN-3262a

Existing new quinolone antibacterial eye drops exhibit insufficient antibacterial activity against S. pneumoniae and P . aeruginosa, which are the main pathogens that cause eye infections.

In addition, eye ointments are used to treat chlamydial conjunctivitis, but such ointments cause discomfort for the patient. Therefore, there is demand for eye drops that are more comfortable to use.

TN-3262a exhibits potent antibacterial activity against the various pathogens that cause eye infections and is being developed as the first eye-drop medication in Japan for the indication of chlamydial conjunctivitis, as well as to treat various bacterial eye infections. The objective is to develop a drug that is highly efficacious and improves the quality of treatment available to patients.

Clinical trials are also underway with a view to using the drug in pediatric patients, including newborns.

Characteristics of TN-3262a

Basic study
•  The compound exhibits potent antibacterial activity against the main pathogens that cause eye infections (including Staphylococcus, Streptococcus, S. pneumoniae, P. aeruginosa, and H . influenzae). The drug is expected to be treat severe eye infections.
•  Compared with existing eye drops, TN-3262a exhibits potent antibacterial activity against Chlamydia, so the drug is expected to prove a useful treatment for chlamydial conjunctivitis, which can only be treated with eye ointments at present.

Clinical study
•  The first placebo-controlled comparative clinical trial on eye drops in Japan has been performed, demonstrating the efficacy of TN-3262a when used as antibacterial eye drops.
•  The first clinical trial in Japan on the use of antibacterial eye drops to treat chlamydial conjunctivitis is underway.
•  The first clinical trial in Japan on the use of antibacterial eye drops to treat pediatric patients, including newborns, is underway.

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