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 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
 www.AveloxUSA.com or call Bayer Clinical Communications at 800-288-8371.
 
     About Bayer Pharmaceuticals Corporation
     Bayer Pharmaceuticals Corporation (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
 
 

SOURCE  Bayer Pharmaceuticals Corporation