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Avelox IV (Moxifloxacin) Approved in Europe to Treat Complicated Skin and Skin Structure Infections LEVERKUSEN, GERMANY -- July 18, 2005 -- Bayer HealthCare today announced that Avelox® IV (moxifloxacin HCl, solution for Infusion) was approved for the treatment of complicated Skin and Skin Structure Infections (cSSSI). The approval procedure which was led by the German Regulatory Authority, (German Federal Institute for Drugs and Medical devices -- BfArM), was successfully completed for this new indication in all 17 European Member States where Avelox IV is licensed.1 Last month, the United States Food and Drug Administration (FDA) approved the cSSSI indication for the USA where Schering-Plough Corporation has acquired the marketing rights for Avelox®. "The severity of cSSSI as a major cause of morbidity makes the approval of Avelox a significant achievement for the patient community," said Dr Martin Springsklee, Head of Anti-Infective Global Clinical Development from Bayer HealthCare's Pharmaceuticals Division. "Treatment of these infections typically involves a combination of antibiotics, often requiring multiple doses per day. Since Avelox® features once-a-day monotherapy, it offers a convenient and effective treatment option for patients." The decision to grant this approval was based on international clinical data which demonstrated that patients taking Avelox® recorded an overall clinical success rate of more than 80 percent, as good as currently approved therapies for this indication. A skin and skin structure infection is complicated when it meets any of the following criteria: 2 - takes place in the presence of a pre-existing wound or ulcer - is caused by an underlying disease state that complicates response to treatment - involves deeper soft tissue - requires significant surgical intervention to resolve Complicated SSSI is a painful and disruptive condition that not only places a significant burden on health care resources but is also responsible for employee absenteeism and lost work time. Each year, an estimated two million people suffer from the infection in France, Germany, Italy, Spain and the United Kingdom alone. "This approval and our further plans with Avelox will establish this brand as a potent therapy for treatment beyond respiratory tract infections," said Alan Westwood, Vice-President, Anti-infective Global Strategic Marketing from Bayer HealthCare's Pharmaceuticals Division. About Avelox Avelox® IV (+ oral sequential therapy) is now approved to treat Community Acquired Pneumonia (CAP), and Complicated Skin and Skin Structure Infections (cSSSI). Avelox® Oral is approved to treat Community Acquired Pneumonia (CAP) – except severe cases, Acute Bacterial Sinusitis (ABS) where adequately diagnosed, and Acute Exacerbations of Chronic Bronchitis (AECB). In Germany Avelox is known as Avalox. For Avelox prescribing information and indicated organisms, log on to www.avelox.com <http://www.avelox.com/> or email global.avelox@bayer.com <mailto:global.avelox@bayer.com>. References: 1 Austria, Belgium, Denmark, Finland, Germany, Greece, Republic of Ireland, Luxembourg, Malta, The Netherlands, Sweden, Hungary, Estonia, Latvia, Lithuania, Slovakia and Slovenia. 2 U.S. Food and Drug Administration (FDA). Guidance for Industry: Uncomplicated and Complicated Skin and Skin Structure Infections - Developing Antimicrobial Drugs for Treatment. Available at <http://www.fda.gov/cder/guidance/2566dft.pdf>. Last accessed on June 10, 2005. SOURCE: Bayer HealthCare AG E-mail this page to a friend or colleague! To print, use this version