Ceftaroline Met Primary Objective and Achieved High Clinical Cure Rates in Adult Patients Hospitalized for Moderate to Severe CABP
NEW YORK, June 19, 2009 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. (NYSE: FRX) announced today positive results from two global multi-center 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% for the ceftaroline group compared with 77.7% for the ceftriaxone group. Ceftaroline therapy was also well tolerated, with an adverse event profile similar to ceftriaxone.
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'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, MD, 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.'
FOCUS I and FOCUS II Study Results
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%. 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), 100% of subjects were PORT Risk Class 3 and 4.
In FOCUS I, ceftaroline-treated patients had a clinical cure rate of 86.6% compared with the ceftriaxone clinical cure rate of 77.7% in the CE population (95% confidence interval [CI] of treatment difference: +1.4, 15.4). In FOCUS II, the respective rates were 82.1% versus 77.2% (95% CI: -2.5, 12.5). For the MITT, the respective rates in FOCUS I were 83.8% versus 77.7% (95% CI: -0.2, 12.6) and in FOCUS II were 81.3% versus 75.5% (95% CI: -1.0, 12.7).
