New Data Show Ceftobiprole as Effective as Combination Therapy in Treating Patients with Diabetic Foot Infections

Raritan, NJ .– Johnson & Johnson Pharmaceutical Research & Development, L.L.C., today announced results from a Phase III trial that showed that investigational antibiotic ceftobiprole was found to clinically cure 86% of patients with diabetic foot infections -- including some infections that were caused by methicillin-resistant Staphylococcus aureus (MRSA).

These data were presented at the 45th annual meeting of the Infectious Disease Society of America (IDSA) in San Diego, California. Ceftobiprole is licensed from, and is being co-developed with, Basilea Pharmaceutica Ltd.

Staphylococcus aureus is the predominant Gram-positive+ bacteria associated with many infections, including complicated skin and skin structure infections (cSSSI) and is carried by approximately 25-30% of the U.S. population. During the last 30 years, MRSA has become more prevalent as a cause of complicated skin and skin structure infections, including diabetic foot infections, which are particularly challenging to treat. In 1974, MRSA accounted for two percent of all Staphylococcus infections in the U.S. In 2004, this figure had risen to 63%.

According to the American Diabetes Association (ADA), nearly 21 million Americans suffer from diabetes. Diabetic foot infections can develop in the skin, muscle, or bones of the foot as a result of nerve damage and poor circulation associated with diabetes. A recent ADA study approximates that as many as nine percent of Americans with diabetes will develop a diabetic foot infection, and that those who do develop such an infection are 55.7 times more likely to require hospitalization and 154.5 times more at risk of amputation.

Ceftobiprole belongs to a class of antibacterial agents known as cephalosporins, which are used to treat serious infections caused by Gram- negative++ and Gram-positive+ bacteria. In clinically evaluable patients, 500 mg of ceftobiprole administered intravenously every eight hours (500 mg IV q8h) demonstrated an 86.2% cure rate compared to an 81.8% cure rate seen with the combination of 1g of vancomycin administered intravenously every 12 hours (1g IV q12h) plus 1g of ceftazidime administered intravenously every eight hours (1g IV q8h).

“Diabetic foot infections are becoming increasingly difficult to treat,” said study author, Gary J. Noel, M.D., Franchise Medical Leader, Anti-Infectives, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. “These data suggest that ceftobiprole may be useful as stand-alone therapy for this increasingly common type of complicated skin infection.”

The use of ceftobiprole in adults for the treatment of complicated skin and skin structure infections, including diabetic foot infections (without concomitant osteomyelitis, an infection of the bone or bone marrow), is under regulatory review in the United States, Europe, Switzerland, Australia and Canada. These data, along with the regulatory submissions, demonstrate the ongoing commitment of Johnson & Johnson Pharmaceutical Research & Development, L.L.C., to developing novel drugs for the anti-infective market.

Study Design

In a Phase III, multi-center, double-blind trial, 257 patients with diabetic foot infections without concomitant osteomyelitis, were randomized to receive either 500mg of ceftobiprole administered intravenously every eight hours (500 mg IV q8h) or 1g of vancomycin administered intravenously every 12 hours (1g IV q12h) plus 1g of ceftazidime administered intravenously every eight hours (1g IV q8h). Severity of diabetic foot infections among the 257 patients varied. Severity was mild (grade 2) in 27%, moderate (grade 3) in 59%, and severe (grade 4) in 13% of trial patients. Additionally, 67% of patients were microbiologically evaluable. The most common pathogens associated with these infections were MSSA (37%), MRSA (15%), E. cloacae (nine percent), S. agalactiae (eight percent), P. mirabilis (eight percent), and P. aeruginosa (eight percent).

Ceftobiprole was well tolerated and the incidence of adverse events in ceftobiprole-treated patients was similar to those observed in the vancomycin plus ceftazidime-treated patients.