Forest Laboratories, Inc. announced positive results from two globally conducted, multi-center phase III studies of ceftaroline, a broad-spectrum cephalosporin with activity against gram-positive bacteria, such as MRSA and gram negative bacteria, for the treatment of complicated skin and skin structure infections (cSSSI).

In both the Canvas I and Canvas II studies, ceftaroline as monotherapy achieved the primary endpoint of non-inferiority versus the combination of vancomycin plus aztreonam. Ceftaroline was generally well tolerated.

"We are extremely pleased with the top-line results demonstrating ceftaroline's efficacy in treating complicated skin and skin structure infections, particularly in difficult to treat patients," said Howard Solomon, chief executive officer of Forest Laboratories. "We recognize the urgent need for new broad-spectrum antibiotics such as ceftaroline to treat the growing number of serious infections involving resistant gram-positive pathogens such as MRSA, and gram-negative pathogens. The positive results of these phase III ceftaroline trials are an important step in advancing Forest's pipeline, including our commitment to building a robust antibiotic franchise".

The two globally conducted, multi-center, phase III, randomized, double-blind comparative studies were designed to evaluate the efficacy and safety of ceftaroline compared to vancomycin plus aztreonam. The data were collected from 1396 adult patients, with cSSSI caused by gram-positive and gram-negative bacteria. Over 30 per cent of patients with a confirmed pathogen had a MRSA infection.

Ceftaroline was statistically proven non-inferior to the combination of vancomycin plus aztreonam. Ceftaroline treated patients had a clinical cure rate of 91.6 per cent compared to a vancomycin plus aztreonam clinical cure rate of 92.7 per cent at test-of-cure (TOC) visit in the clinically evaluable population across both studies. The studies were designed to a non-inferiority margin of 10 per cent between ceftaroline and the comparator regimen. In addition, ceftaroline had a microbiological eradication rate of 92.4 per cent compared to a vancomycin plus aztreonam rate of 93.6 per cent for all pathogens when used as treatment for cSSSI. The ceftaroline clinical cure rate was 93.1 per cent in Staphylococcus aureus infections in the microbiologically evaluable population and 93.3 per cent for MRSA infections.

Ceftaroline is a novel, bactericidal injectable broad-spectrum cephalosporin being developed as a therapeutic agent for the treatment of gram-positive pathogens, including MRSA and multi-drug resistant Streptococcus pneumoniae (MDRSP), as well as common gram-negative organisms. Ceftaroline has also demonstrated bactericidal activity against vancomycin-resistant Staphylococcus aureus (VRSA), linezolid-resistant Staphylococcus aureus and penicillin-resistant Streptococcus pneumoniae (PRSP).