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Moxifloxacin Gains Community-Acquired Pneumonia Indication

WEST HAVEN, Conn., May 19, 2004 /PRNewswire-FirstCall/ -- The United States Food and Drug Administration (FDA) has approved a supplemental new drug application for Avelox (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 100%.

"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.

Source: Bayer Pharmaceuticals Corporation

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