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Bayer AG

Treatment of uncomplicated urinary tract infections
U.S. registration for Bayer's Cipro(R) XR antibiotic
Once-a-day dosing simplifies administration

Leverkusen (ots)

The U.S. Food and Drug Administration (FDA) has
approved Bayer's antibiotic product Cipro(R) XR (Ciprofloxacin
Extended-Release Tablets). This new formulation, given once a day
over three days, is designed to treat uncomplicated urinary tract
infections (UTIs). Cipro(R) XR will be marketed in a dosage strength
of 500 mg, and Bayer will begin shipping the product to U.S.
pharmacies on January 2, 2003.
Cipro(R) XR releases the active ingredient from two layers. The
first releases ciprofloxacin into the blood within hours. This is
followed by a second extended release of the active ingredient to
allow sustained levels over 24 hours.
A study with 891 women showed that once-daily administration of
Cipro(R) XR was as effective as conventional ciprofloxacin
administered twice a day. A clinical cure was achieved in 95 percent
(Cipro(R) XR once daily) versus 93 percent (ciprofloxacin twice
Dr. Wolfgang Plischke, President of the Pharmaceuticals Division
at Bayer HealthCare, commented on the registration: "We can now offer
patients a more convenient medication for the targeted therapy of
uncomplicated urinary tract infections."
According to the National Institutes of Health in the USA, urinary
tract infections are the second most common type of infection,
accounting for more than eight million doctor visits annually in the
USA. Women are especially prone to UTIs.
Bayer submitted an application to the FDA in October 2002 to
market Cipro(R) XR tablets in a 1000 mg dosage strength for
once-a-day therapy of complicated urinary tract infections.
Forward-Looking Statements
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


Dr. Michael Diehl
Phone: +49/214/305'85'32