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

Leverkusen 16.12.2002 (PROTEXT) - The U.S. Food and DrugAdministration (FDA) has approved Bayer's antibiotic productCiproŽ XR (Ciprofloxacin Extended- Release Tablets). This newformulation, given once a day over three days, is designed totreat uncomplicated urinary tract infections (UTIs). CiproŽ XRwill be marketed in a dosage strength of 500 mg, and Bayer willbegin shipping the product to U.S. pharmacies on January 2,2003.

CiproŽ XR releases the active ingredient from two layers. Thefirst releases ciprofloxacin into the blood within hours. Thisis followed by a second extended release of the activeingredient to allow sustained levels over 24 hours.

A study with 891 women showed that once-daily administrationof CiproŽ XR was as effective as conventional ciprofloxacinadministered twice a day. A clinical cure was achieved in 95percent (CiproŽ XR once daily) versus 93 percent (ciprofloxacintwice daily).

Dr. Wolfgang Plischke, President of the PharmaceuticalsDivision at Bayer HealthCare, commented on the registration: "Wecan now offer patients a more convenient medication for thetargeted 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 ofinfection, accounting for more than eight million doctor visitsannually in the USA. Women are especially prone to UTIs.

Bayer submitted an application to the FDA in October 2002 tomarket CiproŽ XR tablets in a 1000 mg dosage strength for once-a-day therapy of complicated urinary tract infections.

Contact: Dr. Michael Diehl, telephone: +49 214 30-58532 e-mail: michael.diehl.md@bayer-ag.de

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