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Forest Laboratories Announces Positive Results from Phase III Clinical Studies of Ceftaroline for the Treatment of Complicated Skin and Skin Structure Infections

Update: Teflaro (ceftaroline fosamil) Now FDA Approved - October 29, 2010
Company's Next-Generation Cephalosporin Effective Against Difficult-to-Treat Skin Infections, Including Those with methicillin-resistant Staphylococcus aureus (MRSA)

NEW YORK, June 19, 2008 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. today announced positive results from two globally conducted, multi-center Phase III studies of ceftaroline, a broad-spectrum cephalosporin with activity against gram-positive bacteria, such as MRSA and gram negative bacteria, for the treatment of complicated skin and skin structure infections (cSSSI). In both the CANVAS I and CANVAS II studies, ceftaroline as monotherapy achieved the primary endpoint of non-inferiority versus the combination of vancomycin plus aztreonam. Ceftaroline was generally well tolerated. Detailed results are expected to be presented later this year at a medical conference.

"We are extremely pleased with the top-line results demonstrating ceftaroline's efficacy in treating complicated skin and skin structure infections, particularly in difficult to treat patients," said Howard Solomon, Chief Executive Officer of Forest Laboratories. "We recognize the urgent need for new broad-spectrum antibiotics such as ceftaroline to treat the growing number of serious infections involving resistant gram-positive pathogens such as MRSA, and gram-negative pathogens. The positive results of these Phase III ceftaroline trials are an important step in advancing Forest's pipeline, including our commitment to building a robust antibiotic franchise."

Design and Results

The two globally conducted, multi-center, Phase III, randomized, double-blind comparative studies were designed to evaluate the efficacy and safety of ceftaroline compared to vancomycin plus aztreonam. The data were collected from 1396 adult patients (702 CANVAS I and 694 CANVAS II), with cSSSI caused by gram-positive and gram-negative bacteria. Over 30% of patients with a confirmed pathogen had a MRSA infection.

Ceftaroline was statistically proven non-inferior to the combination of vancomycin plus aztreonam. Ceftaroline treated patients had a clinical cure rate of 91.6% compared to a vancomycin plus aztreonam clinical cure rate of 92.7% at test-of-cure (TOC) visit in the clinically evaluable population across both studies. The studies were designed to a non-inferiority margin of 10% between ceftaroline and the comparator regimen. In addition, ceftaroline had a microbiological eradication rate of 92.4% compared to a vancomycin plus aztreonam rate of 93.6% for all pathogens when used as treatment for cSSSI. The ceftaroline clinical cure rate was 93.1% in Staphylococcus aureus infections in the microbiologically evaluable population and 93.3% for MRSA infections. The study also indicated that ceftaroline was generally well-tolerated. The overall rate of adverse events was comparable between the two treatment groups. The overall discontinuation rate for ceftaroline was 3.0% compared to 4.8% for vancomycin plus aztreonam.

About Complicated Skin and Skin Structure Infections (cSSSIs)

cSSSIs are caused by gram-positive bacteria, such as MRSA, and common gram-negative bacteria.(1,2) cSSSIs are among the most common infections treated in the hospital setting(3) and MRSA infections are becoming more common in patients in both the hospital and community settings, now the most frequent cause of cSSSI presenting to emergency departments in the United States (U.S.) and the cause of over 18,000 deaths in 2005.(4)

According to the Centers for Disease Control and Prevention, about 70% of bacterial infections are resistant to at least one drug.(5) Many are resistant to multiple drugs making cSSSIs, especially due to MRSA, challenging to treat.(6) cSSSIs can become extremely serious, leading to hospitalization, an increased risk for morbidity and mortality and increased healthcare costs.(4)

About Ceftaroline

Ceftaroline is a novel, bactericidal injectable broad-spectrum cephalosporin being developed as a therapeutic agent for the treatment of gram-positive pathogens, including MRSA and multi-drug resistant Streptococcus pneumoniae (MDRSP), as well as common gram-negative organisms. Ceftaroline has also demonstrated bactericidal activity against vancomycin-resistant Staphylococcus aureus (VRSA), linezolid-resistant Staphylococcus aureus and penicillin-resistant Streptococcus pneumoniae (PRSP). Ceftaroline is a member of the cephalosporin class of antibiotics, the most frequently prescribed class of antibiotics in the world. Ceftaroline is also being studied in Phase III clinical trials for community acquired pneumonia.

About Forest Laboratories

Forest Laboratories is a U.S.-based pharmaceutical company with a long track record of building partnerships and developing and delivering 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.

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.

    References:

    1. DiNubile MJ, Lipsky BA. Complicated infections of skin and skin

       structures: when the infection is more than skin deep. Journal of

       Antimicrobial Chemotherapy (2004) 53, Suppl. S2, ii37-ii50.


    2. R. Finch (2006) Gram-positive infections: lessons learnt and novel

       solutions Clinical Microbiology and Infection 12 (s8) , 3-8

       doi:10.1111/j.1469-0691.2006


    3. Su Young Lee, Joseph L. Kuti, David P. Nicolau. Surgical Infections.

       September 1, 2005, 6(3): 283-295. doi:10.1089/sur.2005.6.283.


    4. Klevens RM, Korrison MA, et al. Invasive Methicillin-Resistant

       Staphylococcus aureus Infections in the United States. JAMA, October

       17, 2007-Vol 298, No. 15.


    5. U.S. Food and Drug Administration. Battle of the Bugs: Fighting

       Antibiotic Resistance. Accessed on May 28, 2008. Available at:

       http://www.fda.gov/fdac/special/testtubetopatient/antibiotics.html.


    6. Scheinfeld N. Journal of Drugs in Dermatology. Jan 2007. A comparison

       of available and investigational antibiotics for complicated skin

       infections and treatment-resistant Staphylococcus aureus and

       Enterococcus.

CONTACT: Charles E. Triano, Vice President, Investor Relations of ForestLaboratories, Inc., +1-212-224-6714, charles.triano@frx.com

Web site: http://www.frx.com/

Ticker Symbol: (NYSE:FRX)

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Posted: June 2008

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