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Bayer Wins Approval for Avelox (Moxifloxacin) in Japan Bayer wins approval for Avelox(R) (Moxifloxacin) in Japan Shionogi & Co. Ltd. has exclusive marketing rights / Japan is the world's second largest pharmaceutical market LEVERKUSEN, GERMANY -- October 21, 2005 -- Bayer HealthCare's Japanese affiliate, Bayer Yakuhin Ltd, announced that it has been granted the importing rights for the oral version of its antibacterial Avelox(R) (moxifloxacin hydrochloride) by the Japanese Ministry of Health, Labour and Welfare. Avelox(R), a quinolone antibacterial, was developed by Bayer HealthCare AG for the treatment of respiratory tract infections (RTIs) and the active ingredient, moxifloxacin, has demonstrated excellent antibacterial efficacy against the major bacterial pathogens that cause these infections. Avelox(R) was first approved in 1999 both in Europe and the United States and to date, there have been more than 40 million patients treated with moxifloxacin for all of its various indications. This approval means that Avelox oral is now licensed in 104 countries around the world. In 2003 Bayer Yakuhin and Shionogi & Co. Ltd. (Shionogi) signed an agreement that provides Shionogi with exclusive Japanese marketing rights for Avelox(R). According to the terms of the agreement, Bayer Yakuhin will continue to hold the drug's registration and Shionogi will exclusively market the product. In order to facilitate the rapid penetration of Avelox(R) into the Japanese market, both companies will work together closely in the areas of marketing and post-marketing surveillance. The Japanese oral anti-infective market was worth over Euro 2000m in 2004. "This approval in the world's second largest pharmaceutical market is further good news for Avelox coming on the back of winning US and European approval for treatment of complicated skin and skin structure infections earlier this year" said Alan Westwood, Vice-President, Anti-infective Global Strategic Marketing from Bayer HealthCare's Pharmaceuticals Division. Shionogi expects to launch Avelox(R) Tablet in December 2005 after National Health Insurance price listing has been obtained. Source: Bayer E-mail this page to a friend or colleague! To print, use this version