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11 Apr 2016

Pooled analysis from seven clinical studies demonstrates consistent efficacy for ceftazidime-avibactam in the treatment of multi-drug resistant Gram-negative bacteria

Encouraging new data relevant to escalating Gram-negative infection crisis presented at 26th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID).

AstraZeneca has presented positive data demonstrating the efficacy of the investigational antibiotic, ceftazidime-avibactam (CAZ-AVI), in treating patients with ceftazidime-resistant Gram-negative infections, which are increasingly resistant to most available antibiotics, often precipitating the need for clinicians to reach for agents previously reserved for last-line use.

The data, from a pooled analysis of seven clinical trials of patients with either complicated Intra-Abdominal Infections (cIAI) or complicated Urinary Tract Infections (cUTI), demonstrated that ceftazidime-avibactam was effective at treating patients with ceftazidime-resistant Gram-negative pathogens caused by Enterobacteriaceae and Pseudomonas aeruginosa. CAZ-AVI was equally effective at treating patients with ceftazidime-resistant or ceftazidime-susceptible Gram-negative pathogens, regardless of underlying infection. In addition, response rates were similar to carbapenem comparators. Alongside cIAI and cUTI, CAZ-AVI is also being studied for the treatment of Nosocomial Pneumonia including Hospital Acquired Pneumonia and Ventilator Associated Pneumonia.

Hans Sijbesma, Managing Director, Antibiotics Business Unit, AstraZeneca, said: "We are encouraged by the data which highlight the potential for CAZ-AVI to address the challenges of treating patients with life-threatening infections where the lack of effective treatment options has a critical impact on mortality, morbidity and associated healthcare costs."

In Europe, it is estimated that Gram-negative bacteria are responsible for two thirds of the 25,000 deaths resulting from antimicrobial resistance reported annually. Resistance to carbapenems is particularly troubling as they are one of the last lines of defence in severe hospital-treated Gram-negative infections.

In addition to the CAZ-AVI data being presented at this year's ECCMID, there are also five abstracts featuring new Zinforo (ceftaroline fosamil) data, an antibiotic approved for the treatment of adult patients with complicated skin and soft tissue infections (cSSTI) or community-acquired pneumonia (CAP), as well as two abstracts for ATM-AVI, an investigational antibiotic being developed for the treatment of targeted serious bacterial infections. CAZ-AVI, Zinforo and ATM-AVI are key antibiotics within AstraZeneca's recently established Antibiotic Business Unit.

CAZ-AVI combines a cephalosporin (ceftazidime) with a next generation non-beta lactam beta-lactamase inhibitor (avibactam). The addition of avibactam protects ceftazidime from being broken down by beta-lactamases that are produced by these resistant bacteria. It is being developed to treat a broad range of Gram-negative bacterial infections which are becoming increasingly resistant to antibiotics and pose a threat to public health, including multi-drug resistant P. aeruginosa, carbapenem-resistant Gram-negative pathogens, & ESBL-producing Enterobacteriaceae.

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