Navigation Links
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: )

"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

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.


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


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:

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


SOURCE Forest Laboratories, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Ironwood Pharmaceuticals and Forest Laboratories Announce Presentation of Linaclotide Phase 2b Chronic Constipation Study Results
2. Forest and Almirall Announce Positive Results of Clinical Studies for Aclidinium Bromide, a Novel, Long-Acting Anticholinergic for the Treatment for COPD
3. Microbia and Forest Laboratories Announce Preliminary Results of Linaclotide Phase 2b Studies
4. Forest Laboratories, Inc. Announces Positive Results of LEXAPRO(R) Phase III Study in Adolescents With Major Depression
5. Forest Laboratories, Inc. and Gedeon Richter Announce Results of Phase II-B Study for RGH-188 as a Treatment for Schizophrenia
6. Daiichi Sankyo and Forest Laboratories Finalize Contract for Co-Promotion of AZOR(TM)
7. Romark Laboratories Completes Enrollment in U.S. Phase II Study of Nitazoxanide for Chronic Hepatitis C Genotype 1 Non-Responders
8. Northfield Laboratories Inc. Presentation at FDA/NIH Workshop on Hemoglobin-Based Oxygen Carriers
9. Romark Laboratories Initiates Phase II Study of Nitazoxanide in Treatment-Naive Patients With Chronic Hepatitis C Genotype 1
10. Romark Laboratories Raises $18 Million in Institutional Financing
11. eRT Announces the Availability of the Suicidality Monitoring System(TM) For Clinical Trials
Post Your Comments:
(Date:11/26/2015)... Nov. 26, 2015 Research and Markets ... the "2016 Future Horizons and Growth Strategies ... Supplier Shares, Country Segment Forecasts, Competitive Intelligence, Emerging ... --> --> This ... the Italian therapeutic drug monitoring market, including emerging ...
(Date:11/25/2015)... , Nov. 25, 2015  Amgen (NASDAQ: AMGN ... Application (BLA) with the United States ... 501, a biosimilar candidate to Humira ® (adalimumab). ... application submitted to the FDA and represents Amgen,s first ... Sean E. Harper , M.D., executive vice president of ...
(Date:11/25/2015)... Nov. 25, 2015  ARKRAY USA ... to provide evidence demonstrating the accuracy of its blood ... on Insulin Resistance, Diabetes and Cardiovascular Disease in ... the Company,s GLUCOCARD ® 01 meter and the ... requirements. The ability to accurately measure glucose levels in ...
Breaking Medicine Technology:
(Date:11/28/2015)... ... , ... Safe storage for contraceptive devices may not always be easy to ... and the other from Bradley Beach, New Jersey, there is an easy solution to ... to replace NuvaRings more often than necessary. As such, it affords peace of mind ...
(Date:11/27/2015)... ... November 28, 2015 , ... There is only one major question facing ... last year? , This question has not been an easy question to answer. Especially ... age and the younger workforce don’t share the same discipline around working long hours. ...
(Date:11/27/2015)... ... 27, 2015 , ... The rapid speed at which Americans ... more care is needed, especially with Alzheimer’s, dementia and other cognitive conditions becoming ... The forgotten part of this equation: 80 percent of medical care occurs in ...
(Date:11/27/2015)... ... 27, 2015 , ... Lizzie’s Lice Pickers just announced a special promotion that ... of their purchase of lice treatment product. In addition, customers will receive a complimentary ... spokesperson. “Finding lice is a sure way to ruin the holidays, so we encourage ...
(Date:11/27/2015)... , ... November 27, 2015 , ... ... of progress through sharing, the 2016 Building Better Radiology Marketing Programs ... will begin on Sunday, March 6, 2016, at Caesars Palace in Las Vegas ...
Breaking Medicine News(10 mins):