FOCUS 1 and FOCUS 2 clinical trial results released

Sep 14 2009

Forest Laboratories, Inc (NYSE: FRX) today presented at the 49^th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Francisco new data from a complete analysis of FOCUS 1 and FOCUS 2, two global multicenter Phase III studies of ceftaroline for the treatment of community-acquired pneumonia (CAP) in hospitalized patients. Detailed analyses from the previously reported top-line data of the two pivotal trials demonstrated that ceftaroline administered intravenously met the primary endpoint of non-inferiority in patients with moderate to severe CAP requiring hospitalization. Ceftaroline therapy was also generally well tolerated, with an adverse event profile similar to ceftriaxone.

CAP is a serious illness and common cause of mortality and morbidity. In the U.S. an estimated 5.6 million cases of CAP occur annually, resulting in an average of 4.5 million visits to physicians’ offices and as many as 1.1 million hospitalizations.

Integrated Results

The randomized, double-blind, multicenter Phase III studies compared clinical outcomes following treatment with ceftaroline versus ceftriaxone in hospitalized adult patients with moderate to severe CAP.

The combined results of FOCUS 1 and FOCUS 2 demonstrated a clinical cure rate of 84.3% for ceftaroline and 77.7% for ceftriaxone in the integrated clinically evaluable (CE) patient population. The overall microbiological response rate in the microbiologically evaluable (ME) population was 87% for ceftaroline and 81% for ceftriaxone, and in the microbiological modified intent-to-treat (MITT) population it was 84.8% for ceftaroline and 80.4% for ceftriaxone.

“The robust data that have emerged from FOCUS 1 and 2 demonstrate that ceftaroline is a very promising new cephalosporin for the treatment of serious pneumonia in hospitalized patients,” said Dirk Thye, MD, President of Cerexa, the wholly owned anti-infectives subsidiary of Forest Laboratories, Inc. “The continuing medical need to deal with emerging resistance to existing therapeutic options is clear and urgent. These results, along with our prior positive results in complicated skin and skin structure infections (cSSSI)⁵, confirm that ceftaroline has unique properties allowing it to address this medical need. We intend to submit our New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for cSSSI and CAP around the end of this calendar year.”

In addition to these two pivotal studies for CAP, data on the microbiology of ceftaroline is being presented at ICAAC, demonstrating its bactericidal activity in vitro and in animals against a broad range of pathogens including those commonly implicated in both cSSSI and CAP, as well as MRSA and multi-drug resistant Streptococcus pneumoniae (MDRSP).

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