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Forest Laboratories Presents Analysis Of Two Positive Pivotal Phase III Studies Of Ceftaroline For The Treatment Of Community-Acquired Pneumonia (CAP)

September 19, 2009

Forest Laboratories, Inc (NYSE: FRX) presented at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Francisco starting anew data from a complete analysis of FOCUS 1 and FOCUS 2, two global multicenter Phase III studies of ceftaroline for the treatment of community-acquired pneumonia (CAP) in hospitalized patients. Detailed analyses from the previously reported top-line data of the two pivotal trials demonstrated that ceftaroline administered intravenously met the principal endpoint of non-inferiority in patients with moderate to severe CAP requiring hospitalization.1 Ceftaroline therapy was also in most cases well tolerated, with an adverse issue side view homogeneous to ceftriaxone.

CAP is a serious illness and common cause of subjection to death and morbidity. In the U.S. each estimated 5.6 million cases of CAP occur year by year, resulting in an mean proportion of 4.5 the great body of the people visits to physicians’ offices and as many as 1.1 million hospitalizations.2,3,4

Integrated Results

The randomized, double-blind, multicenter Phase III studies compared clinical outcomes following usage with ceftaroline versus ceftriaxone in hospitalized adult patients with moderate to severe CAP.

The combined results of FOCUS 1 and FOCUS 2 demonstrated a clinical cure berate of 84.3% for ceftaroline and 77.7% for ceftriaxone in the integrated clinically evaluable (CE) constant enumerate of men. The overall microbiological rejoinder rate in the microbiologically evaluable (ME) population was 87% for ceftaroline and 81% with regard to ceftriaxone, and in the microbiological modified intent-to-treat (MITT) population it was 84.8% for ceftaroline and 80.4% for ceftriaxone.

“The robust data that own emerged from FOCUS 1 and 2 demonstrate that ceftaroline is a very promising new cephalosporin for the management of serious pneumonia in hospitalized patients,” said Dirk Thye, MD, President of Cerexa, the wholly owned anti-infectives subsidiary of Forest Laboratories, Inc. “The continuing medical need to deal with emerging resistance to existing therapeutic options is clear and pertinacious. These results, along with our prior indisputable results in complicated pelt and skin structure infections (cSSSI)5, confirm that ceftaroline has unique properties allowing it to address this medicinal indigence. We intend to submit our New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) beneficial to cSSSI and CAP around the end of this calendar year.”

In etc. to these couple pivotal studies for CAP, data on the microbiology of ceftaroline is being presented at ICAAC, demonstrating its bactericidal nimbleness in vitro and in animals in countervail to a broad range of pathogens including those commonly implicated in the two cSSSI and CAP, as well as MRSA and multi-drug resistant Streptococcus pneumoniae (MDRSP).

Posters

— Snydman DR, Jacobus NV, et al. In Vitro Activity of Ceftaroline vs a Broad Spectrum of Recent Clinical Anaerobic Isolates. Poster #903-M-060.6

— Citron DM, Goldstein EJC, et al. In Vitro Activity of Ceftaroline Against Anaerobic Bacteria. Poster #903-M-058.7

— Farrell DJ, Patel SN, et al. Activity of Ceftaroline (CPT) Against Recent Streptococcus pneumoniae (SP) Isolates From the Canadian Bacterial Surveillance Network (CBSN). Poster #903-M-067. 8

— Jacobs MR, Bajaksouzilan S, et al. Activity of Ceftaroline Against Emerging Serotypes of Streptococcus pneumoniae. Poster #903-M-069. 9

— Jones RN, Sader HS, et al. Antimicrobial Activity of Ceftaroline Tested against streptococci from United States (USA) and European (EU) Medical Centers: Results from the Ceftaroline Longitudinal Assessment of Spectrum and Susceptibility (CLASS) Program. Poster #0903-M-035.10

— Vidaillac C. Newton K, et al. Evaluation of Oxacillin, Daptomycin, and Ceftaroline Activity Against Clinical Vancomycin Heterovariant Methicillin-Resistant Staphylococcus aureus (MRSA). Poster #903-M-074.11

— Jacqueline C, Amador G, et al. Activity of Ceftaroline (CPT) vs Daptomycin (DAP), and Tigecycline (TGC) Against Methicillin-Susceptible, Methicillin-Resistant, and Glycopeptide-Intermediate Staphylococcus aureus: An Experimental Rabbit Endocarditis Study. Poster #903-M-042.12

— Sader HS, Mendes RE, et al. Antimicrobial Activity of Ceftaroline Tested Against Streptococci From United States (USA) and European (EU) Medical Centers: Results from the Ceftaroline Longitudinal Assessment of Spectrum and Susceptibility (CLASS) Program. Poster #0903-M-035.13

— Kosowska-Shick K, McGhee P, Appelbaum P. Affinity of Ceftaroline and Caparator b-lactams to Penicillin-Binding Proteins (PBPs) from Staphylococcus aureus. Poster #903-M-041.14

About Ceftaroline and Ceftaroline / NXL104

Ceftaroline is a novel, bactericidal, injectable, broad-spectrum cephalosporin being developed as a therapeutic performer in opposition to the method of treating of cSSSI and CAP that embrace gram-positive pathogens such like methicillin-resistant Staphylococcus aureus (MRSA) and multidrug-resistant S. pneumoniae (MDRSP), as fortunate as inferior gram-negative organisms. Ceftaroline has demonstrated antibacterial activity in vitro against vancomycin-resistant S. aureus (VRSA) and linezolid-resistant S. aureus. Ceftaroline is a portion of the cephalosporin class of antibiotics, the most frequently prescribed class of antibiotics in the world. In clinical trials, ceftaroline has been generally well tolerated by an adverse event profile consistent with the cephalosporin rank of antibiotics. Forest obtained the worldwide rights (excluding Japan, where Takeda Pharmaceuticals holds rights) to ceftaroline when it acquired Cerexa, Inc, a secretly held biopharmaceutical company, in 2007. In August 2009, Forest Laboratories and AstraZeneca (NYSE:AZN) entered into a categorical collaboration agreement to co-develop and commercialize ceftaroline in entirely markets outside the U.S., Canada and Japan.

Forest is likewise developing a cabal outcome consisting of ceftaroline and NXL104, a novel beta-lactamase inhibitor. The combination of NXL104 through ceftaroline enhances the in vitro antibacterial activity of ceftaroline against extended-spectrum beta-lactamase-producing (ESBL) gram-negative bacteria that are normally resistant to currently available broad-spectrum cephalosporins.

About CAP Requiring Hospitalization

In 2006, pneumonia, side by side with influenza, was the eighth leading cause of death in the U.S. and the number one aim of death in those over age 65.15,16The cost of care according to patients with CAP in the U.S. has been estimated to be over $10 billion annually.17

The primary usage for CAP is antibiotics14 and the rates of resistance to many commonly used antibiotics is increasing.18 S. pneumoniae accounts for 60% to 70% of all bacterial CAP cases and data have shown that, overall, pneumococcal strains had a 28% intermediate resistance rate and a 16% high-level resistance rate.19 With increasing rates of inflammation of the lungs caused by MRSA and the high rates of rebuff to indifferent antibiotics, management options are becoming more limited.20

About Forest Laboratories

Forest Laboratories (NYSE: FRX) is a U.S.-based pharmaceutical crew with a long trace record of construction partnerships and developing and marketing 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 whole stages of increase and across a wide range of therapeutic areas.

Except for the historical knowledge contained in this respect, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements inwrap 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 hazard factors listed from time to time in Forest Laboratories’ Annual Report upon Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC filings.

References

(1). Eckberg P, Friedland HD, et al. FOCUS 1 and 2: Randomized, Double-blinded, Multicenter Phase 3 Trials of the Efficacy and Safety of Ceftaroline (CPT) vs. Ceftriaxone (CRO) in Community-acquired pneumonia (CAP). Presentation L1-345a. Presented at ICAAC 2009.

(2). Neiderman MS, McCombs JI, Inger AN, Kumar A, Popovian R. The cost of treating community-acquired pneumony in the United States. JAMA. 1996; 275: 189-193.

(3). Garibaldi RA. Epidemiology of community-acquired respiratory tract infections in adults: incidents, etiology and impact. Am J Med. 1985:78:32S-37S.

(4). Centers for Disease Control and Prevention. Premature deaths, monthly humanity and monthly physicians contacts United States. MMWR Morb Mortal Wkly Rep. 1997; 46:556.

(5). Corey R, Wilcox M, Talbot GH, et al. CANVAS-1: Randomized, Double-blinded, Phase 3 Study (P903-06) of the Efficacy and Safety of Ceftaroline vs. Vancomycin plus Aztreonam in Complicated Skin and Skin Structure Infections (cSSSI). Presented at ICAAC / IDSA 2008.

(6). Snydman DR, Jacobus NV, et al. In Vitro Activity of Ceftaroline vs a Broad Spectrum of Recent Clinical Anaerobic Isolates. Poster #903-M-060. Presented at ICAAC 2009.

(7). Citron DM, Goldstein EJC, et al. In Vitro Activity of Ceftaroline Against Anaerobic Bacteria. Poster #903-M-058. Presented at ICAAC 2009.

(8). Farrell DJ, Patel SN, et al. Activity of Ceftaroline (CPT) Against Recent Streptococcus pneumoniae (SP) Isolates From the Canadian Bacterial Surveillance Network (CBSN). Poster #903-M-067. Presented at ICAAC 2009.

(9) Jacobs MR, Bajaksouzilan S, et al. Activity of Ceftaroline Against Emerging Serotypes of Streptococcus pneumoniae. Poster #903-M-069. Presented at ICAAC 2009.

(10) Jones RN, Sader HS, et al. Antimicrobial Activity of Ceftaroline Tested against streptococci from United States (USA) and European (EU) Medical Centers: Results from the Ceftaroline Longitudinal Assessment of Spectrum and Susceptibility (CLASS) Program. Poster #0903-M-035 Presented at ICAAC 2009.

(11) Vidaillac C. Newton K, et al. Evaluation of Oxacillin, Daptomycin, and Ceftaroline Activity Against Clinical Vancomycin Heterovariant Methicillin-Resistant Staphylococcus aureus (MRSA). Poster #903-M-074. Presented at ICAAC 2009.

(12) Jacqueline C, Amador G, et al. Activity of Ceftaroline (CPT) vs Daptomycin (DAP), and Tigecycline (TGC) Against Methicillin-Susceptible, Methicillin-Resistant, and Glycopeptide-Intermediate Staphylococcus aureus: An Experimental Rabbit Endocarditis Study. Poster #903-M-042. Presented at ICAAC 2009.

(13) Sader HS, Mendes RE, et al. Antimicrobial Activity of Ceftaroline Tested Against Streptococci From United States (USA) and European (EU) Medical Centers: Results from the Ceftaroline Longitudinal Assessment of Spectrum and Susceptibility (CLASS) Program. Poster #0903-M-035. Presented at ICAAC 2009.

(14) Kosowska-Shick K, McGhee P, Appelbaum P. Affinity of Ceftaroline and Caparator b-lactams to Penicillin-Binding Proteins (PBPs) from Staphylococcus aureus. Poster #903-M-041 Presented at ICAAC 2009.

(15) Centers for Disease Control and Prevention. National Center for Health Statistics. Deaths: Preliminary Data for 2005. September 2007.

(16). Heron M, Hoyert D, Murphy S. National Vital Statistics Reports. Deaths: Final Data for 2006. 2009 April; 57:14.

(17). Lave, JR, Lin CJ, Fine MJ, et al. The require to be paid of treating patients with community-acquired pneumonia. Semin Respir Crit Care Med. 1999;20(3):189-97.

(18). Official Statement of the American Thoracic Society. Guidelines for the Management of Adults with Community-acquired Pneumonia. Am J Repir Cric Care Med. 2001;163:1730-1754.

(19). Lutfiyya MN, Henley E, Chang L. Diagnosis and Treatment of Community-Acquired Pneumonia. Am Fam Physician. 2006 Feb 1;73(3):442-50.

(20). Mandell L. Wunderink A, Anzueto, J, et al. Infectious Diseases Society of America / America Thoracic Society consensus guidelines on the management of community-acquired pneumonia in adults. Clin Infect Dis. 2007;44:(Suppl. 2)S27-S72.

Source: Forest Laboratories

Written by Samanta · Filed Under Pharmacy Industry News