Forest Laboratories Announces Positive Results from Phase III Clinical Studies of Ceftaroline for the Treatment of Complicated S
June 19 2008 - 7:50AM
PR Newswire (US)
Company's Next-Generation Cephalosporin Effective Against
Difficult-to-Treat Skin Infections, Including Those with
methicillin-resistant Staphylococcus aureus (MRSA) NEW YORK, June
19 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. (NYSE:FRX)
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. (Logo:
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO ) "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 (NYSE:FRX) 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 http://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.
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO
http://photoarchive.ap.org/ DATASOURCE: Forest Laboratories, Inc.
CONTACT: Charles E. Triano, Vice President, Investor Relations of
Forest Laboratories, Inc., +1-212-224-6714, Web site:
http://www.frx.com/
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