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:11/30/2015)... , Nov. 30, 2015  DURECT ... that Matt Hogan , Chief Financial ... Healthcare Conference on Tuesday, December 8 at ... being held at the Westin Grand Central ... be available for one-on-one meetings at this ...
(Date:11/30/2015)... SAN FRANCISCO , Nov. 30, 2015 ... and Designers of Things (DoT ) co-located events ... Printing and the Internet of Things, will draw more ... San Jose Convention Center. The events, combined ... their latest technologies. --> ...
(Date:11/30/2015)... CHICAGO , Nov. 30, 2015 Nautilus ... next-generation Radiology Image Management platform ( ). The ... was announced from RSNA 2015 (Radiology Society North America) ... Radiology conference in the U.S. --> ... radiology platform that enables access to radiology studies worldwide ...
Breaking Medicine Technology:
(Date:11/30/2015)... Fla. (PRWEB) , ... November 30, 2015 , ... ... opened the driverless vehicle experience this summer, ushering in a new era of ... percent driverless and electric shuttle, will continue to offer guests an up-close look ...
(Date:11/30/2015)... (PRWEB) , ... November 30, 2015 , ... The presidential ... of personal styling. So why is it a national news story when Donald Trump ... Parsa Mohebi, M.D., because appearances count more than anyone wants to admit when it ...
(Date:11/30/2015)... ... November 30, 2015 , ... The Progressive ... TX, on January 29 and 30, 2016. The course welcomes dental professionals and ... practices, to learn how to better succeed in the modern dental marketplace. The ...
(Date:11/30/2015)... Georgia (PRWEB) , ... November 30, 2015 , ... ... of a key disease-causing component of bacteria could be effective in fighting methicillin-resistant ... at Georgia State University. , Their study showed that small molecule analogs that ...
(Date:11/30/2015)... NJ (PRWEB) , ... November 30, 2015 , ... Dr. ... With three office locations, patients can visit Dr. Margulies to experience the best available ... to hold the title of "NJ Top Dentist"! , Orthodontics is the branch of ...
Breaking Medicine News(10 mins):