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Avelox Approved to Treat Complicated Intra-Abdominal Infections

LEVERKUSEN, Germany, November 30, 2005 - Bayer HealthCare announced today that the FDA has approved its quinolone antibiotic Avelox (moxifloxacin) for the treatment of complicated intra-abdominal infections (cIAI) in the US. This news follows just six months after the US regulator approved Avelox in complicated skin and skin structure infections (cSSSI) and represents a further broadening of Avelox's key indications beyond respiratory tract infections. Avelox is now the only promoted fluoroquinolone monotherapy approved by the FDA for the treatment of cIAI. In the US, Avelox is marketed by Bayer's partner Schering-Plough Corporation.

Intra-abdominal infections can be caused by conditions such as trauma, intra-abdominal surgery or other diseases that result in spillage or spread of bacteria from the gastrointestinal tract into the abdomen. There are approximately 3.5 million cases each year in the US1.

"Avelox offers considerable benefits over standard therapy for intra-abdominal infections" said Dr Martin Springsklee, Head of Anti-Infective Global Clinical Development from Bayer HealthCare's Pharmaceuticals Division, "Not only does it offer the convenience of a single daily-dose monotherapy but also allows an easy step-down from IV to oral treatment. This makes Avelox an attractive proposition for healthcare professionals treating this indication".

Clinical trials demonstrated that sequential IV to oral Avelox therapy given once daily was as effective as IV piperacillin/tazobactam given four times daily followed by oral amoxicillin/clavulanic acid twice daily. A second study compared Avelox with IV ceftriaxone plus metronidazole followed by oral amoxicillin/clavulanic acid. Avelox was effective at eradicating the key pathogens in cIAIs including E.coli and B.fragilis.

"The additional indications this year of first cSSSI and now IAI will make Avelox an even more attractive option for hospital formulary committees and offer substantial opportunities for growth in the hospital market." said Alan Westwood, Vice-President, Anti-infective Global Strategic Marketing from Bayer HealthCare's Pharmaceuticals Division.

Bayer plans to make a submission to the European Regulatory authorities for this indication in due course.

About Avelox

In Europe2, Avelox IV (+ oral sequential therapy) is 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 the US, Avelox is approved to Acute Exacerbations of Chronic Bronchitis (AECB), Acute Bacterial Sinusitis (ABS), Community Acquired Pneumonia (CAP), Uncomplicated Skin and Skin Structure Infections (uSSSI), Complicated Skin and Skin Structure Infections (cSSSI) and Complicated Intra-Abdominal Infections (cIAI).

Source: Bayer HealthCare AG

1. Data Source: The Hospital Antibiotic Market Guide by AMR/Arlington Medical Resources, Inc.; MAT June 2004. (Intra-abdominal Infection cases based on Bayer HealthCare customized definition)
2. Avelox IV is licensed in the following 17 European Member States: Austria, Belgium, Denmark, Finland, Germany, Greece, Republic of Ireland, Luxembourg, Malta, The Netherlands, Sweden, Hungary, Estonia, Latvia, Lithuania, Slovakia and Slovenia.

Posted: November 2005