Study Comparing Once-Daily Cipro XR to Conventional Twice-Daily Cipro Supports Safety and Efficacy of Cipro XR for the Treatment of Uncomplicated Urinary Tract Infections.

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SAN DIEGO--(BUSINESS WIRE)--Sept. 30, 2002

New formulation utilizes bilayer matrix of active ingredient

Study results announced today show that 500 mg CIPRO(R) XR (ciprofloxacin HCl and ciprofloxacin), a new formulation of ciprofloxacin, given once-a-day over three days for uncomplicated urinary tract infection (UTI) was comparable in safety and efficacy to the conventional twice-daily dose (250 mg) of Cipro(R) (ciprofloxacin HCl).

The results of this US multi-center clinical trial were presented at the 42nd Interscience Conference on Antimicrobial Agents and Chemotherapy in San Diego (ICAAC) by Dr. Ernie Riffer, Central Phoenix Medical Clinic, AZ.

The new once-daily formulation was developed using a bilayer matrix of the active ingredient ciprofloxacin. This new formulation enables the rapid release of ciprofloxacin, which distributes to the serum and tissues within hours. This is followed by a second extended release of the active ingredient over 24 hours.

Uncomplicated UTIs are responsible for an estimated 8 million physician visits per year in the US(1). "We developed Cipro XR in direct response to the needs of our customers. We asked physicians what was most important to their UTI patients and once-a-day dosing was a common response," said Dr. Larry Posner, senior vice president, Pharmaceutical Development; worldwide head, Regulatory Affairs, Ethical Pharmaceuticals, Bayer Corporation.

The prospective, randomized, double-blinded study followed the treatment of 891 adult women with clinical signs and symptoms of acute uncomplicated UTI, including pyuria, and a positive pre-therapy urine culture. The treatment groups were similar with respect to demographics and infection characteristics.

At the first assessment point, 4-11 days post-treatment, bacteriologic eradication was achieved in 94% in the once daily therapy arm and 94% in the twice a day-treated patients; clinical cure was observed in 95% of the once-daily treated patients compared to 93% of twice-daily therapy patients. Eradication of E. coli, the most predominant organism, was 97% for each group. These rates were consistent with those that investigators observed in the late treatment follow-up (25-50 days post-therapy). Drug related adverse events were similar for each group and included nausea, headache, vaginal moniliasis, and vaginitis.

According to Dr. Riffer, "This study showed that the new extended release formulation of once-daily ciprofloxacin was comparable to twice-daily ciprofloxacin over a three-day course of therapy for uncomplicated UTIs."

Bayer Corporation submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in March 2002 to market Cipro XR for the treatment of uncomplicated UTI in the once daily tablet formulation used in this trial.

About Bayer Corporation

Best known for its flagship product, Bayer Aspirin, Bayer Corporation produces a broad range of healthcare, crop protection, polymer and chemical products that help diagnose and treat diseases, purify water, preserve local landmarks, protect crops, advance automobile safety and durability and improve people's lives.

Headquartered in Pittsburgh, Bayer Corporation had sales of $10.1 billion in 2001 and is one of Fortune magazine's Most Admired Companies. The company employs 21,500 people. It is a member of the worldwide Bayer Group, a $27 billion international healthcare and chemicals group based in Leverkusen, Germany. The Bayer Group stock is a component of the DAX and is listed on the New York Stock Exchange (ticker symbol: BAY).

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 developments.

(1) Hooton(TM), Stamm WE EPIDEMIOLOGY OF Uncomplicated Urinary Tract Infections INF DIS CLIN NOR AMER 1997 citation 11:551-581.

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