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Forest Laboratories Announces Positive Top-line Data from Two Pivotal Phase III Trials of Ceftaroline for the Treatment of Community-acquired Bacterial Pneumonia (CABP) Requiring Hospitalization
Date:6/19/2009

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."

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SOURCE Forest Laboratories, Inc.
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