November 30, 2005

Avelox® Approved in US to Treat Complicated Intra-abdominal Infections

Once-a-day Dosage Offers Effective and Convenient Treatment Option

Leverkusen - 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).

In Germany Avelox is known as Avalox.

For Avelox prescribing information and indicated organisms, log on to or email

About Bayer HealthCare AG
Bayer HealthCare AG, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the health care and medical products industry. In 2004, the Bayer HealthCare subgroup generated sales amounting to some 8.5 billion Euro.

The company combines the global activities of the divisions Animal Health, Biological Products, Consumer Care, Diabetes Care, Diagnostics and Pharmaceuticals. Bayer HealthCare employed 35,300 people worldwide in 2004.

Bayer HealthCare's aim is to discover and manufacture innovative products that will improve human and animal health worldwide. The products enhance well-being and quality of life by diagnosing, preventing and treating disease.


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.

Forward-looking statements<br/>
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including our Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.