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
--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 via COMTEX/ -- 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 II Study Results
The two Phase III clinical trials randomized 1,241 patients (1:1 randomization) and were designed to evaluate the efficacy, safety and tolerability of a 5-7 day treatment course of ceftaroline (600 milligram twice a day) compared with ceftriaxone (1 gram once a day), utilizing a non-inferiority design with a margin of 10%. The patients were hospitalized adults with moderate to severe CABP requiring treatment with intravenous antimicrobials. In the co-primary populations (modified intent-to-treat [MITT] and CE populations), 100% of subjects were PORT Risk Class 3 and 4.
In FOCUS I, ceftaroline-treated patients had a clinical cure rate of 86.6% compared with the ceftriaxone clinical cure rate of 77.7% in the CE population (95% confidence interval [CI] of treatment difference: +1.4, 15.4). In FOCUS II, the respective rates were 82.1% versus 77.2% (95% CI: -2.5, 12.5). For the MITT, the respective rates in FOCUS I were 83.8% versus 77.7% (95% CI: -0.2, 12.6) and in FOCUS II were 81.3% versus 75.5% (95% CI: -1.0, 12.7). According to the integrated data, in subjects infected with Streptococcus pneumoniae, the most common pathogen in CABP, the clinical cure rates achieved with ceftaroline were 85.5% and 68.6% for ceftriaxone.
For both studies combined, the percentage of patients who experienced an adverse event was similar between treatment groups. The adverse event rates for ceftaroline were consistent with previously reported trials. Discontinuation rates due to adverse events were also similar between treatment groups (3.1% ceftaroline versus 2.4% ceftriaxone).
About Ceftaroline and Ceftaroline/NXL104
Ceftaroline is a novel, bactericidal, injectable, broad-spectrum cephalosporin being developed as a therapeutic agent for the treatment of cSSSI and CABP which include gram-positive pathogens such as methicillin-resistant Staphylococcus aureus (MRSA) and multidrug-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-level resistance rate(8). With increasing rates of pneumonia caused by MRSA and the high rates of resistance to common antibiotics, treatment options are limited(9).
About Forest Laboratories
Forest Laboratories (NYSE: FRX) is a U.S.-based pharmaceutical company with a long track record of building partnerships and developing and marketing products that make a positive difference in people's lives. In addition to its well-established franchises in therapeutic areas of the central nervous and cardiovascular systems, Forest's current pipeline includes product candidates in all stages of development and across a wide range of therapeutic areas. The company is headquartered in New York, NY. To learn more about Forest Laboratories, visit www.FRX.com. Cerexa, a wholly-owned subsidiary of Forest Laboratories, is a biopharmaceutical company focused on developing a growing portfolio of novel anti-infective therapies for the treatment of serious and life-threatening infections.
Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in Forest Laboratories' Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC filings.