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Positive Study Results for Ceftaroline Phase III Clinical Study for the Treatment of Complicated Skin and Skin Structure Infections Presented at ICAAC / IDSA
Date:10/27/2008

New Data on Ceftaroline, a Novel, Broad-Spectrum Cephalosporin in Development for Complicated Skin and Skin Structure Infections (cSSSI) and Community Acquired Pneumonia (CAP)

WASHINGTON, Oct. 27, 2008 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. (NYSE: FRX) presented a detailed analysis of CANVAS I, a globally conducted, multi-center, Phase III clinical trial, at the 48th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy / Infectious Diseases Society of America 46th Annual Meeting (ICAAC / IDSA) in Washington, DC. The results of this 702 patient study demonstrated that ceftaroline monotherapy achieved its primary endpoint of non-inferiority versus the combination of vancomycin and aztreonam in the treatment of complicated skin and skin structure infections (cSSSI).(1)

(LOGO: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )

Forest also presented eighteen abstracts on data from preclinical studies that demonstrate the activity of ceftaroline against methicillin-resistant Staphylococcus aureus (MRSA), multi-drug resistant Streptococcus pneumoniae (MDRSP) and many gram-negative pathogens in both in vitro and in vivo models of infection.

Results of the CANVAS I study presented on Sunday show that ceftaroline-treated patients had a clinical cure rate of 91.1% compared to a vancomycin-plus-aztreonam clinical cure rate of 93.3% at the test of cure (TOC) visit in the clinically evaluable population (CE). In the modified-intent-to-treat (MITT) population, ceftaroline-treated patients had a clinical cure rate of 86.6% compared to a vancomycin-plus-aztreonam clinical cure rate of 85.6%. The study was de
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SOURCE Forest Laboratories, Inc.
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