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| |  Bayer seeks Pediatric Cystic Fibrosis Indication for Cipro WEST HAVEN, Conn., March 11, 1996 - Bayer Corporation announced today it has submitted a Supplemental New Drug Application (SNDA) to the U.S. Food and Drug Administration (FDA) for clearance to market CIPRO(R) (ciprofloxacin HCl/Tablets) and CIPRO(R) IV (ciprofloxacin) as a treatment for the acute pulmonary infections often experienced by children and adolescents with cystic fibrosis (CF). CF is characterized by chronic infection and obstruction of the airways due to the production of a viscous mucus that severely congests the lungs, which leads to fatal lung disease. CIPRO(R), currently available in oral and intravenous formulations, is an antibacterial agent active against a broad range of organisms. Bayer is requesting labeling changes for both formulations that include new dosage recommendations for pediatric patients between the ages of five and 17 based on safety and efficacy data from the largest prospective pediatric CF clinical trial involving antimicrobial agents to date. "Interest expressed by the medical community, particularly pediatric infectious disease physicians and pulmonologists, has been the predominant force behind the clinical development of ciprofloxacin in the pediatric patient group," said Steven Jungerwirth, M.D., Director for anti-infective clinical research at Bayer. "There are clinical situations, such as the management of cystic fibrosis, where CIPRO(R) Tablets could be an appropriate choice in treating resistant bacteria or severe infections which would otherwise require intravenous antimicrobial treatment," added Dr. Jungerwirth. In 1989, Bayer initiated prospective clinical trials involving children and adolescents living with CF. This followed the "compassionate use" of ciprofloxacin both in the United States and Europe among pediatric patients for whom available antimicrobial therapy was either inadequate or contraindicated. Among its current indications, CIPRO(R) is prescribed for the adult treatment of lower respiratory tract infections. Respiratory tract infections are common in the CF population, and the corporation's SNDA addresses the need for a safe and effective treatment against CF-related bacterial lung infections in children. "It's estimated that cystic fibrosis, the most common fatal genetic disease in Caucasians, afflicts one out of every 3,000 newborns in the United States and Europe each year," stated Stacey FitzSimmons, Ph.D., Director of Clinical Research at the Cystic Fibrosis Foundation. "A child with the disease requires consistent, routine treatment and it is critical that proper lung care procedures are part of this treatment. The possibility of a new therapy, such as the use of CIPRO for the acute bacterial exacerbations experienced by these children, could represent an important treatment option in the future," added Dr. FitzSimmons. According to Dr. Jungerwirth, "Bayer is proud to be on the leading edge of research that may give children with cystic fibrosis an important option for therapy." If cleared for use by children with CF who are over five years old, CIPRO(R) may possibly represent a significant cost saving when used in place of traditional dual intravenous antibiotic therapy and when hospitalization is avoided. CIPRO(R) has been marketed by Bayer Corporation in most European countries and in the United States since 1987 for the treatment of a wide variety of infectious diseases in adult patients. Adverse events that have been reported with its use include nausea, diarrhea, vomiting and abdominal pain. Bayer Corporation, the U.S. subsidiary of the international chemical and health care company Bayer AG, Germany, is a research-based company with major businesses in health care, chemicals and imaging technologies. Headquartered in Pittsburgh, Bayer employs 24,000 people and had 1995 sales of more than $7.1 billion.
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