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New Data Show Ceftobiprole as Effective as Combination Therapy in Treating Patients With Complicated Skin Infections, Including MRSA
Date:9/18/2007

d skin infections, including diabetic foot infections. Results of the combined analysis of two studies also showed that treatment with 500 mg of ceftobiprole administered intravenously every eight or every 12 hours (500 mg IV q8h or q12h) clinically cured more than 90% of patients with complicated skin infections caused by S. aureus. Among ceftobiprole-treated patients with MRSA, PVL-positive MRSA, or PVL-positive S. aureus infections, cure rates consistently exceeded 90%.

"These results demonstrate that ceftobiprole, as a single agent, may be as effective as commonly used combination therapy in treating a range of today's serious Gram-negative and Gram-positive infections, such as MRSA," said study author, Gary J. Noel, M.D., Franchise Medical Leader, Anti-Infectives, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

The use of ceftobiprole for the treatment of complicated skin and skin structure infections (cSSSI), including diabetic foot infections, in adults 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 Results

In a Phase III, double-blind, randomized, multi-center trial, 828 patients with cSSSI were stratified by infection type -- diabetic foot infections, cellulitis, abscesses and wound infections. Patients were assessed for clinical outcomes and microbiologic eradication of a range of bacteria at infection sites seven to 14 days after completion of therapy with either 500 mg of ceftobiprole administered intravenously every eight hours (500 mg IV q8h) or a combination of 1 g of vancomycin administered intravenously every 12 hours (1 g IV q12h) plus 1 g of ceftazidime administered intravenously every eight hours (1 g IV q8h).

In the most recently completed tri
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SOURCE Johnson & Johnson Pharmaceutical Research & Development,
L.L.C.
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