WEST HAVEN, Conn., Aug. 28, 2003 /PRNewswire/ -- Bayer Pharmaceuticals Corporation announced today that the U.S. Food and Drug Administration (FDA) has approved a once-daily formulation of Cipro(R) XR (ciprofloxacin* extended-release tablets) for the treatment of complicated urinary tract infections (cUTIs) and acute uncomplicated pyelonephritis (AUP), or kidney infection. The new formulation can be taken once a day for 7-14 days at a dose of 1000mg.

Cipro XR is specifically formulated to be taken just once daily to kill certain bacteria causing urinary tract infections. The new formulation was developed using a bilayer matrix of the active ingredient ciprofloxacin, which enables two different release mechanisms. The first is a rapid release of ciprofloxacin, which quickly distributes to the serum and tissues. This is followed by a second extended release of the active ingredient to achieve high concentrations of ciprofloxacin in the urine for the full 24-hour dosing interval. In December 2002, the FDA approved Cipro XR as a once-daily, three-day treatment for uncomplicated urinary tract infections at a dose of 500mg. Cipro XR 500mg was launched in January 2003.

"The once-a-day convenience of Cipro XR may contribute to compliance among patients, thereby helping to reduce the risk of UTI relapse and subsequent resistant infection," said Dr. David Talan, Professor of Medicine, David Geffen School of Medicine at UCLA. "By combining once-a-day dosing with excellent antimicrobial activity, Cipro XR may be recommended as a convenient option for the appropriate and targeted treatment of complicated UTIs." * as ciprofloxacin+ and ciprofloxacin hydrochloride + does not comply with the loss on drying test and residue on ignition test of the USP monograph.

Results of a prospective, randomized, double-blind, North American multicenter clinical trial were included in the New Drug Application (NDA) submitted to the FDA in October 2002. The study enrolled 1,042 patients and compared 1000mg once-daily Cipro XR to a twice-daily 500 mg dose of conventional Cipro(R) (ciprofloxacin HCl). Adult male and female patients were evaluated based on the presence of cUTI and acute uncomplicated pyelonephritis. Evaluation was based on bacteriologic and clinical outcomes.

Bacteriologic eradication (evaluated 5 to 11 days post-therapy) was achieved in 89% of patients with cUTI treated with once-daily Cipro XR and 81% of patients treated with conventional twice-daily Cipro. For patients with AUP, bacteriologic eradication of E. coli was achieved in 97% treated with once-daily Cipro XR and 100% of patients treated with conventional twice-daily Cipro.

Clinical cure (evaluated 5 to 11 days post-therapy) was observed in 96% of cUTI patients treated once a day with Cipro XR 1000mg, compared with 91% of patients receiving the traditional Cipro 500mg twice daily. For patients with AUP, clinical cure was observed in 98% of patients percent treated with once-daily Cipro XR and 96% of patients treated with conventional twice-daily Cipro.

Rates of drug-related adverse events were similar in both groups. Adverse reactions determined to be at least possibly drug-related occurring in at least 1% of patients were nausea (3%), diarrhea (2%), headache (1%), dyspepsia (1%), dizziness (1%), and vaginal moniliasis (1%). Vomiting (1%) occurred in the 1000mg group.

"After 15 years, Cipro has a long standing heritage in the treatment of urinary tract infections," said Mary Taylor, Vice President, Regulatory Affairs, North America, Bayer Pharmaceuticals Corporation. "Bayer is thrilled to be able to provide a new once-daily treatment that can effectively eradicate these infections in patients."

About Complicated Urinary Tract Infections (cUTIs) and Acute Uncomplicated Pyelonephritis (AUP)

Urinary tract infections are a serious health problem, accounting for millions of physician visits each year. UTIs are most often caused by bacteria and are frequently treated with antibiotics, such as fluoroquinolones.

Uncomplicated UTIs are generally only associated with bacterial infection. Complicated UTIs are usually caused by a combination of bacteria and an anatomical or structural abnormality in the urinary tract. Uncomplicated UTIs affect women more than men, but complicated UTIs occur nearly as often in men as in women.(1) Abnormalities or risk factors for complicated UTI include kidney stones, catheter use, diabetes, and prostate conditions in men. Complicated UTI is often associated with recurrent infections if the underlying abnormality is not corrected.(2)

AUP, otherwise known as a kidney infection, is an upper urinary tract infection involving the kidney and renal pelvis and most commonly results from inadequately treated UTIs. Every year in the United States, about 250,000 women develop pyelonephritis, and 100,000 are hospitalized. Symptoms can include frequent and irritating urination, as well as and strong-smelling urine that can be cloudy and contains blood, chills and fever lasting more than two days, back pain along the waist level, vomiting and nausea.(3)

Indications and Important Safety Information

Cipro XR is indicated for the treatment of uncomplicated urinary tract infections (acute cystitis) caused by Escherichia coli, Proteus mirabilis, Enterococcus faecalis, or Staphylococcus saprophyticus (a); complicated urinary tract infections caused by Escherichia coli, Klebsiella pneumoniae, Enterococcus faecalis, Proteus mirabilis, or Pseudomonas aeruginosa (a), and acute uncomplicated pyelonephritis caused by Escherichia coli.

(a) Treatment of infections due to this organism in this organ system was studied in fewer than 10 patients.

Serious and fatal reactions have been reported in patients receiving concurrent administration of ciprofloxacin and theophylline. Monitor theophylline levels if concurrent administration cannot be avoided.

The safety and effectiveness of Cipro XR in children, adolescents less than 18 years of age, pregnant women and lactating women have not been established. Cipro XR is contraindicated in persons with a history of hypersensitivity to ciprofloxacin or any quinolone, and should be discontinued at the first sign of an allergic reaction.

Adverse reactions determined to be at least possibly drug-related occurring in > 1% of patients were nausea (3%), diarrhea (2%), headache (1%), dyspepsia (1%), dizziness (1%), and vaginal moniliasis (1%). Vomiting (1%) occurred in the 1000mg dose.

Cipro XR should be administered at least 2 hours before or 6 hours after antacids containing magnesium, aluminium, calcium, or other products containing metal cations. A 2-hour window between substantial calcium intake (>800 mg) and dosing with Cipro XR is recommended.

DO NOT SPLIT, CRUSH, OR CHEW THE TABLET.

Full prescribing information for CIPRO XR can be viewed at http://www.ciproxr.com/

About Bayer Pharmaceuticals Corporation

Bayer Pharmaceuticals Corporation 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 Reuters Health. Urinary Tract Infections: General Description of a Urinary Tract Infection. September 2001. Available at http://www.reutershealth.com/wellconnected/doc36.html. Accessed March 25, 2003.

2 Reuters Health. Urinary Tract Infections: Specific Risk Factors for Complicated UTIs. September 2001. Available at http://www.reutershealth.com/wellconnected/doc36.html. Accessed March 25, 2003.

3 Reuters Health. Urinary Tract Infections: Symptoms of Kidney Infection (Pyelonephritis). September 2001. Available at http://www.reutershealth.com/wellconnected/doc36.html. Accessed March 25, 2003.

Source: Bayer Pharmaceuticals Corporation
CONTACT: Mark Bennett of Bayer Pharmaceuticals Corporation, +1-203-812-2160
Web Site: http://www.ciproxr.com/ http://www.reutershealth.com/wellconnected/doc36.html