Forest Laboratories Announces Positive Results from Phase III Clinical Studies of...

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

SOURCE Forest Laboratories, Inc.

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