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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

drug-resistant S. pneumoniae (MDRSP), as well as common gram-negative organisms. Ceftaroline has demonstrated antibacterial activity in-vitro against vancomycin-resistant S. aureus (VRSA) and linezolid-resistant S. aureus. Ceftaroline is a member of the cephalosporin class of antibiotics, the most frequently prescribed class of antibiotics in the world. In clinical trials, ceftaroline has been generally well tolerated with a safety profile consistent with the cephalosporin class of antibiotics. Forest obtained the worldwide rights (excluding Japan) to ceftaroline when it acquired Cerexa in 2007.

Forest is also developing a combination product consisting of ceftaroline and NXL104, a novel beta-lactamase inhibitor. The combination of NXL104 with ceftaroline enhances the in vitro antibacterial activity of ceftaroline against extended-spectrum beta-lactamase-producing (ESBL) gram-negative bacteria that are normally resistant to currently available broad-spectrum cephalosporins.

About CABP Requiring Hospitalization

Community-acquired bacterial pneumonia is a serious illness and a common cause of mortality and morbidity. In 2006, pneumonia, along with influenza, was the eighth leading cause of death in the U.S. and the number one cause of death in those over age 65(1,2). An estimated 5.6 million cases of CABP occur annually in the U.S. resulting in an average of 4.5 million visits to physicians' offices and as many as 1.1 million hospitalizations(3,4,5). The cost of care for patients with CABP in the U.S. has been estimated to be over $10 billion annually(6).

The primary treatment for CABP is antibiotics(7) and the rates of resistance to many commonly used antibiotics is increasing(8). S. pneumoniae accounts for 60 to 70% of all bacterial CABP cases and data has shown that, overall, pneumococcal strains had a 28% intermediate resistance rate and a 16% high
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SOURCE Forest Laboratories, Inc.
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