Forest Laboratories, Inc announced positive results from two global multi-centre phase-III studies of ceftaroline for the treatment of community-acquired bacterial pneumonia (CABP). The top-line data in each of the pivotal trials (FOCUS I and II) demonstrate that ceftaroline met the primary objective of non-inferiority and achieved high clinical cure rates compared with ceftriaxone in patients with moderate to severe community-acquired bacterial pneumonia requiring hospitalization. According to the integrated efficacy data from the two clinical studies, the clinical cure rate in the clinically evaluable (CE) population was 84.3 per cent for the ceftaroline group compared with 77.7 per cent for the ceftriaxone group. Ceftaroline therapy was also well tolerated, with an adverse event profile similar to ceftriaxone.

"We are extremely pleased with the results emanating from both phase-III CABP studies. These results represent a significant development milestone for ceftaroline," said Dirk Thye, president of Cerexa, the wholly-owned anti-infectives subsidiary of Forest Laboratories, Inc. "The positive CABP phase-III clinical studies, along with the positive phase-III study results in CANVAS I and II, in complicated skin and skin structure infections (cSSSI), will serve as the basis for our New Drug Application, which we expect to file around calendar year-end."

The two Phase III clinical trials randomized 1,241 patients (1:1 randomization) and were designed to evaluate the efficacy, safety and tolerability of a 5-7 day treatment course of ceftaroline (600 milligram twice a day) compared with ceftriaxone (1 gram once a day), utilizing a non-inferiority design with a margin of 10 per cent. The patients were hospitalized adults with moderate to severe CABP requiring treatment with intravenous antimicrobials. In the co-primary populations (modified intent-to-treat [MITT] and CE populations), cent per cent of subjects were PORT Risk Class 3 and 4.

In FOCUS I, ceftaroline-treated patients had a clinical cure rate of 86.6 per cent compared with the ceftriaxone clinical cure rate of 77.7 per cent in the CE population (95 per cent confidence interval [CI] of treatment difference: +1.4, 15.4). In FOCUS II, the respective rates were 82.1 per cent versus 77.2 per cent (95 per cent CI: -2.5, 12.5). For the MITT, the respective rates in FOCUS I were 83.8 per cent versus 77.7 per cent (95 per cent CI: -0.2, 12.6) and in FOCUS II were 81.3 per cent versus 75.5 per cent (95 per cent CI: -1.0, 12.7). According to the integrated data, in subjects infected with Streptococcus pneumoniae, the most common pathogen in CABP, the clinical cure rates achieved with ceftaroline were 85.5 and 68.6 per cent for ceftriaxone.

For both studies combined, the percentage of patients who experienced an adverse event was similar between treatment groups. The adverse event rates for ceftaroline were consistent with previously reported trials. Discontinuation rates due to adverse events were also similar between treatment groups (3.1 per cent ceftaroline versus 2.4 per cent ceftriaxone).

Ceftaroline is a novel, bactericidal, injectable, broad-spectrum cephalosporin being developed as a therapeutic agent for the treatment of cSSSI and CABP which include gram-positive pathogens such as methicillin-resistant Staphylococcus aureus (MRSA) and multidrug-resistant S. pneumoniae (MDRSP), as well as common gram-negative organisms.

Forest Labs is a US-based pharmaceutical company with a long track record of building partnerships and developing and marketing products that make a positive difference in people's lives.