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 Hospi...( Ceftaroline Met Primary Objective and...),Health

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
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