FDA Approves Avelox(R) (moxifloxacin HCI) for Community Acquired Pneumonia Due to Multi-Drug Resistant Streptococcus pneumoniae

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 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.

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,

[phone], or fax, [phone]



Web site:  http://www.bayer.com/ 

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