Bayer Welcomes The Proposed EMEA Labeling Changes For Moxifloxacin

Main Category: Respiratory / Asthma
Also Included In: Ear, Nose and Throat;  Regulatory Affairs / Drug Approvals;  Infectious Diseases / Bacteria / Viruses
Article Date: 28 Jul 2008 - 1:00 PDT

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Bayer is pleased to announce that today the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) proposed a labeling change for oral moxifloxacin for the treatment of Acute Exacerbations of Chronic Bronchitis (AECB), Acute Bacterial Sinusitis (ABS) and Community Acquired Pneumonia (CAP) in line with official European clinical guidelines.

"We welcome the CHMP review which confirms the positive benefit-risk profile of moxifloxacin as we believe this is an important treatment option for patients," said Dr. Kemal Malik, member of the Bayer HealthCare Executive Committee and Chief Medical Officer. "We would also welcome an EMEA assessment of other antibiotics used for treatment of these infections in a similar fashion in the interest of patient care."

"Due to increasing resistance of Streptococcus pneumoniae in Europe, commonly used first line agents may not be appropriate in these countries. Oral moxifloxacin remains an important treatment option in these respiratory tract infections", said Prof. Hartmut Lode, Research Center for Medical Studies, Berlin.

On July 14, 2008, the European Commission granted a further indication for moxifloxacin tablets for the treatment of mild to moderate Pelvic Inflammatory Disease (PID) in all European countries.

About Moxifloxacin

Moxifloxacin is an antimicrobial in the fluoroquinolone class. It is marketed under the brand names Avelox®, Avalox®, Izilox®, Actira®, Octegra®, Proflox®, Actimax®, Lapinix®, Havelox®, Avelon®, Megaxin® and Promira®. Moxifloxacin has been used in more than 98 million patients worldwide.

About Bayer

The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma AG. Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at http://www.bayerhealthcare.com.

About Bayer Schering Pharma

Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life. Find more information at http://www.bayerscheringpharma.de.

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup 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 Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

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