Allergan plc announces data at ASM Microbe Highlight In Vitro Antimicrobial Activity of AVYCAZ

Allergan plc a leading global pharmaceutical company committed to developing new treatment options for infectious diseases, today presented new data highlighting the in vitro activity of AVYCAZ® (ceftazidime and avibactam) against several species of Gram-negative pathogens, including certain strains of Klebsiella pneumoniae carbapenemase (KPC)-producing Enterobacteriaceae and Pseudomonas aeruginosa.
Results were presented at the 2016 ASM Microbe meeting in Boston (June 16-20, 2016) in two separate studies—one of which featured data from the International Network for Optimal Resistance Monitoring (INFORM) program, one of the largest ongoing pathogen surveillance programs in the United States.
Klebsiella pneumoniae carbapenemase (KPC)-producing bacteria are a type of carbapenen-resistant Enterobacteriaceae (CRE), which the Centers for Disease Control and Prevention (CDC) has identified as one of the three most urgent public health threats specific to antibiotic resistance. KPC accounts for approximately 85 percent of all CRE infections in the U.S.[1]  resistant Pseudomonas aeruginosa is also considered a serious threat by the CDC 1
"KPC and Pseudomonas aeruginosa represent two of the most serious pathogens causing healthcare-associated infections and are a major challenge in many of today's hospitals," said David Nicholson, Ph.D., President and Executive Vice President, Global R&D, Allergan. "These data and other learnings from the INFORM program reflectAllergan's continued commitment to research that advances our understanding of difficult-to-treat Gram-negative pathogens and guides our ongoing
development of treatments for serious infections."
One of the studies found AVYCAZ inhibited the majority of isolates evaluated in vitrofrom 11 Enterobacteriaceae species, including E. coli and KPC-producing Gram-negative bacteria. This study, presented in a poster titled "Ceftazidime-avibactam (CAZ-AVI) activity tested against eleven Enterobacteriaceae (ENT) species producing KPC enzymes," included an evaluation of 662 KPC-producing Enterobacteriaceae clinical isolates collected worldwide from 2009 to 2014. Susceptibility testing was performed on each isolate for AVYCAZ, meropenem, amikacin, tigecycline and colistin using reference broth microdilution methods, and breakpoint criteria from the U.S. Food and Drug Administration (FDA) and European Committee on Antimicrobial Susceptibility Testing (EUCAST) were applied to the test results.
A second and separate study, presented in a poster titled "Activity of Ceftazidime-Avibactam Tested Against Clinical Isolates of Antimicrobial Resistant Pseudomonas aeruginosa (PSA) from United States (USA) Medical Centers (2012-2014)," found AVYCAZ exhibited in vitro activity against the majority of evaluated Pseudomonas aeruginosa strains, and retained activity against resistant isolates. This study evaluated 5,643 Pseudomonas aeruginosa isolates collected from 2012 to 2014 from 74 U.S. medical centers in the INFORM Surveillance Program, part of a research effort developed and supported by Allergan that monitors the prevalence and changing trends of resistant bacteria, as well as the in vitro activity of antibiotics against these pathogens. Susceptibility testing was performed on each isolate for AVYCAZ, ceftazidime alone, meropenem, piperacillin-tazobactam and amikacin using reference broth microdilution methods, and breakpoint criteria from the U.S. FDA were applied to the test results.
AVYCAZ is an antibiotic developed to treat certain serious Gram-negative bacterial infections. It consists of ceftazidime, a third-generation cephalosporin that is an established and respected treatment for serious Gram-negative bacterial infections, and avibactam, a non-β lactam β-lactamase inhibitor.
The determination of efficacy of AVYCAZ was supported in part by the previous findings of the efficacy and safety of ceftazidime for the treatment of complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI). The contribution of avibactam to AVYCAZ was primarily established in vitro and in animal models of infection. AVYCAZ was studied in two Phase 2 randomized, blinded, active-controlled, multicenter trials, one each in cIAI and cUTI.  These trials were not designed with any formal hypotheses for inferential testing against the active comparators.
About Allergan
Allergan plc headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model—Growth Pharma. Allergan is focused on developing, manufacturing, and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines, and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women's health, urology, cardiovascular and anti-infectives therapeutic categories, and operates the world's third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Allergan is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.
With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, health care providers, and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.
For more information, visit Allergan's website at .

Lisa DeFrancesco 

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Mark Marmur
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