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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.

New quinolone antibacterial eye drops TN-3262a licensed out to South Korean firm Dong-A
February 23, 2004

On February 19, 2004, Toyama Chemical Co., Ltd. (President: Katsuhiko Nakano) executed a licensing agreement with South Korean firm Dong-A Pharmaceutical Co., Ltd. for the new quinolone antibacterial eye drops TN-3262a (generic name: tosufloxacin tosilate), which are currently under joint development in Japan by Toyama Chemical and Nidek Co., Ltd.

Overview of the agreement

Toyama Chemical will grant Dong-A Pharmaceutical exclusive rights to develop and sell TN-3262a in South Korea.

  • Toyama Chemical will supply the finished product.
  • Dong-A Pharmaceutical will pay a contract fee as compensation for the use of Toyama Chemical's patents and know-how.

TN-3262a in Japan

Tosufloxacin tosilate was originated by Toyama Chemical and launched in 1990 as the oral new quinolone synthetic antibacterial Ozex Tablets. The compound is currently under development for use as eye drops (code name: TN-3262a). Based on licensing and joint development agreements concluded in 1998 between Toyama Chemical and Nidek, clinical trial on TN-3262a has been completed and preparations to filing are underway in Q2 2004. In addition, Otsuka Pharmaceutical, which already has a track record in ophthalmology sales, was granted Japanese sell rights in March 2003, in a move aimed at accelerating market penetration. Nidek had previously been granted Japanese sell rights, so both companies will market the drug in Japan.

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 ).
  • Compared with existing drugs, TN-3262a exhibits potent antibacterial activity against Chlamydia .

Clinical study

  • Clinical research confirmed excellent efficacy and safety when used to treat various external eye infections* (conjunctivitis, chlamydial conjunctivitis, blepharitis, styes, meibomitis, dacryocystitis, keratitis, and corneal ulcers). In addition, high eradication rates were obtained when used in preoperation.
  • Clinical studies have been performed on the use of TN-3262a eye drops to treat chlamydial conjunctivitis (trachoma), which can only be treated with eye ointments at present, and Toyama Chemical plans to file for approval of this indication.
  • The first-ever clinical studies have been performed in Japan on the use of an antibacterial eye-drop medication to treat pediatric patients, including newborns, confirming the efficacy and safety of TN-3262a.

<Reference>

Profile of Dong-A Pharmaceutical Co., Ltd.
Head office : 252 Yongdu-Dong, Dongdaemun-Gu, Seoul, South Korea
Established : December 1, 1932
President : Mr.Moon Seok Kang
Capital : 45.6 billion won
Listed : Korea Stock Exchange
Employees : 1,886 (as of end-December 2003)
Sales : 407.9 billion won (results for fiscal year ending December 2003)
Business scope : Manufacture and sale of pharmaceuticals, quasi-drugs, and food and beverage materials
Website : http://www.donga.co.kr
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