FDA Approves Avelox(R) (moxifloxacin HCI) for Community Acquired Pneumonia Due to Multi-Drug Resistant Streptococcus pneumoniae Approval Marks First I.V. Antibiotic Approved to Treat Resistant Strains of Most Common Cause of Bacterial pneumonia WEST HAVEN, Conn., May 19 /PRNewswire-FirstCall/ -- The United States Food and Drug Administration (FDA) has approved a supplemental new drug application for Avelox(R) (moxifloxacin HCI) Tablets and I.V. for the treatment of community acquired pneumonia (CAP) caused by multi-drug resistant Streptococcus pneumoniae (MDRSP*). Avelox is the first antibiotic available in both tablet and I.V. forms approved to treat CAP caused by these strains, which are resistant to the antibiotics most commonly used to treat pneumonia. Two to three million cases of CAP are reported annually in the United States, resulting in 10 million physician visits, 500,000 hospitalizations and 45,000 deaths each year.(1) Currently, CAP is the sixth leading cause of death in the United States.(2) While the majority of CAP cases are caused by S. pneumoniae,(3) the cases of this bacteria becoming resistant to antibiotics are rising. Common antibiotics used to treat CAP such as azithromycin and penicillin have S. pneumoniae resistance rates of 29% and 25%, respectively, and resistance is continuing to rise.(4) Avelox demonstrated excellent clinical and bacteriological success against strains resistant to two to five commonly used antibiotics, including macrolides such as clarithromycin and azithromycin, penicillin, second-generation cepholosporins such as cefuroxime, trimethoprim-sulfamethoxazole, and tetracyclines with eradication rates of 93% to 95%. "The rise of resistance among S. pneumoniae is complicating the treatment of pneumonia worldwide," said Paul MacCarthy, M.D., Vice President, Medical Science, Bayer Pharmaceuticals Corporation. "Antibiotic failure due to resistance can result in prolonged suffering for patients, time lost from work, increased healthcare costs, and serious illnesses that can lead to increased mortality. With approval to treat MDRSP in tablet and I.V. forms, Avelox will be an important treatment option for CAP especially during this time of emerging resistance to conventional therapies." "The approval of Avelox in another critical indication (MDRSP) may allow us to grow our market share further and expand our strong anti-infective franchise with development programs that bring other critical indications on line over the life span of the drug," said Colin Foster, President and CEO, Bayer Pharmaceuticals Corporation. About Avelox Avelox is approved to treat: Community Acquired Pneumonia (CAP) caused by Streptococcus pneumoniae (including multi-drug resistant strains*) Haemophilus influenzae, Moraxella catarrhalis, Staphylococcus aureus, Klebsiella pneumoniae, Mycoplasma pneumoniae, or Chlamydia pneumoniae; Acute Bacterial Exacerbations of Chronic Bronchitis (ABECB) caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Staphylococcus aureus, or Moraxella catarrhalis; Acute Bacterial Sinusitis (ABS) caused by Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis; and Uncomplicated Skin and Skin Structure Infections (uSSSI) caused by Staphylococcus aureus or Streptococcus pyogenes. *MDRSP, Multi-drug resistant Streptococcus pneumoniae, includes isolates previously known as PRSP (penicillin-resistant Streptococcus pneumoniae), and are strains resistant to two or more of the following antibiotic classes: penicillin (MIC greater than or equal to 2 mcg/mL), second generation cephalosporins, e.g. cefuroxime, macrolides, tetracyclines and trimethoprim/ sulfamethoxazole. Important Safety Considerations Avelox is a prescription medication that is generally well tolerated. The most common side effects, which are usually mild, include nausea, diarrhea, and dizziness. You should be careful about driving or operating machinery until you are sure Avelox is not causing dizziness. You should not take Avelox if you have ever had an allergic reaction to Avelox or any of the other group of antibiotics known as "quinolones," such as ciprofloxacin or levofloxacin. You should avoid taking Avelox if you have been diagnosed with an abnormal heartbeat such as an arrhythmia or are using certain medications used to treat an abnormal heartbeat. These include quinidine, procainamide, amiodarone, and sotalol. If you are pregnant or planning to become pregnant while taking Avelox, talk to your healthcare provider before taking this medication. Avelox is not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown. Avelox is not recommended for children under the age of 18 years. Many antacids and multivitamins may interfere with the absorption of Avelox and may prevent it from working properly. You should take Avelox either four hours before or eight hours after taking these products. Be sure to inform your healthcare provider of any medical conditions you have and all prescription and non-prescription medications or supplements you are taking. If you have any concerns about your medication or side effects, please contact your healthcare provider. For Avelox prescribing information and indicated organisms, log on to http://www.aveloxusa.com/ or call Bayer Clinical Communications at 800-288-8371. About Bayer Pharmaceuticals Corporation Bayer Pharmaceuticals Corporation (http://www.bayerpharma.com/) is part of the worldwide operations of Bayer HealthCare, a subgroup of Bayer AG. Bayer HealthCare is one of the world's leading innovators in the health care and medical products industry. Bayer HealthCare combines the global activities of the business groups of Bayer AG in the fields of Biological Products, Consumer Care, Diagnostics, Animal Health and Pharmaceuticals. More than 34,000 employees support the worldwide operations of Bayer HealthCare. Our work at Bayer HealthCare is to discover and manufacture innovative products for the purpose of improving human and animal health worldwide. Our products enhance well-being and quality of life by diagnosing, preventing and treating disease. 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. (1) Bartlett, J. et al. Clin Infect Dis 2000; 31:347-82 (2) Bartlett, J. et al. Clin Infect Dis 2000; 31:347-82 (3) Whitney, C. et al. N Engl J Med 2000; 343:1917-24. (4) Jacobs et al. The Alexander Project 1998-2000. J Antimicrob Chemother. 2003;52:229-46 DATASOURCE: Bayer Pharmaceuticals Corporation CONTACT: Mark Bennett of Bayer Pharmaceuticals Corporation, +1-203-812-2160, or fax, +1-203-812-5824 Web site: http://www.bayer.com/

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