New Data Show Ceftobiprole As Effective As Combination Therapy In Treating Patients With Complicated Skin Infections, Incluiding Area

Main Category: Dermatology
Also Included In: Infectious Diseases / Bacteria / Viruses;  Pharma Industry / Biotech Industry;  MRSA / Drug Resistance
Article Date: 20 Sep 2007 - 15:00 PDT

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Johnson & Johnson Pharmaceutical Research & Development, L.L.C., announced that the investigational antibiotic ceftobiprole was as effective as commonly used combination therapy in treating patients with complicated skin infections caused by a broad spectrum of bacteria. Ceftobiprole also was found to clinically cure more than 90% of patients who had infections caused by Staphylococcus aureus (S. aureus), including patients with complicated skin infections due to PVL-positive methicillin-resistant S. aureus (MRSA).

These new data were presented in two posters at the 47th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC).

Ceftobiprole belongs to a class of antibacterial agents known as cephalosporins, which are used to treat serious, life-threatening infections caused by Gram-negative1 and Gram-positive2 bacteria. Ceftobiprole is licensed from, and is being co-developed with, Basilea Pharmaceutica Ltd.

MRSA is a growing public health threat both in hospital and community settings and is becoming an increasingly common source of life-threatening infections in otherwise healthy people. Approximately 25% to 30% of the U.S. population carries S. aureus, the predominant bacterial species associated with skin infections. PVL, the abbreviation for Panton-Valentine Leukocidin, is a toxin that -- when found in S. aureus -- "lyses," or breaks open, white blood cells and tissue cells which are needed to help the body fight the infection.

Data presented demonstrated that 500 mg of ceftobiprole administered intravenously every eight hours (500 mg IV q8h) was as effective and well tolerated as the commonly used 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 eradicating a broad spectrum of Gram-positive and Gram-negative bacteria associated with complicated 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 trial, ceftobiprole alone was as effective as the combination therapy at eradicating methicillin-susceptible S. aureus (MSSA) (91% vs. 92%, respectively); MRSA (87% vs. 86%); S. pyogenes (90% vs. 100%); S. agalactiae (81% vs. 75%); E. coli (86% vs. 92%); P. aeruginosa (83% vs. 89%); and, Enterobacter spp., Klebsiella pneumoniae, and Proteus mirabilis (86% vs. 83%) from the site of infection.

Other data from two, pooled, Phase III, double-blind, randomized, multi-center global trials involving 817 patients with cSSSI examined the frequency and clinical outcome of patients infected with PVL-positive S. aureus. Patients were randomized to receive either 500 mg of ceftobiprole administered intravenously every eight or every 12 hours (500 mg IV q8h or q12h), 1 g of vancomycin administered intravenously every 12 hours, 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). Results showed that 38% of the S. aureus (n=310), 28% of MSSA (n=157/565), and 51% of MRSA (n=157/310) causing these skin infections were PVL-positive.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) is part of Johnson & Johnson, the world's most broadly based producer of healthcare products. J&JPRD is headquartered in Raritan, NJ, and has facilities throughout Europe, the United States and Asia. J&JPRD is leveraging drug discovery and drug development in a variety of therapeutic areas to address unmet medical needs worldwide.

[This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the Company's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2006. Copies of this Form 10-K, as well as subsequent filings, are available online at http://www.sec.gov or on request from the Company. The Company does not undertake to update any forward-looking statements as a result of new information or future events or developments.]

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1. Gram-negative indicates a group of bacteria that become red when the bacterial cells are treated using the Gram stain method. This response is based on the chemical and physical properties of their cell walls and is used to identify the type of bacteria. Some Gram-negative bacteria may cause serious infections.

2. Gram-positive indicates a group of bacteria that become blue when the bacterial cells are treated with the Gram stain. This response is based on the chemical and physical properties of their cell walls and is used to identify the type of bacteria. Some Gram-positive bacteria may cause serious infections.

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