AstraZeneca and Forest Laboratories to initiate phase III clinical trials for ceftazidime/avibactam

AstraZeneca and Forest Laboratories, Inc. announced today that ceftazidime/avibactam (CAZ-AVI) will enter phase III trials to investigate efficacy in treating hospitalised patients with serious Gram-negative bacterial infections including Complicated Intra-Abdominal Infections (cIAI) and Complicated Urinary Tract Infections (cUTI). CAZ-AVI combines a broad-spectrum cephalosporin (ceftazidime) and a novel beta-lactamase inhibitor (avibactam, formerly NXL104) to overcome antibiotic-resistance and treat the increasing number of infections resistant to existing therapies.

This study programme will include five phase III trials designed to demonstrate that CAZ-AVI is an effective and well tolerated treatment for patients with cIAI and cUTI including those patients with infections that may be resistant to currently available antibiotics.

This study programme builds on results from two separate CAZ-AVI phase II trials:

• The cIAI Phase II trial showed that the efficacy of CAZ-AVI given with metronidazole in adult patients was similar to meropenem, an established treatment given to patients with Complicated Intra-Abdominal Infections
• The cUTI Phase II trial showed that the efficacy of CAZ-AVI in adult patients was similar to imipenem cilastatin, an established treatment given to patients with Complicated Urinary Tract Infections
• The data from both trials showed that CAZ-AVI in general was well tolerated.

“This new step in the development of CAZ-AVI demonstrates our commitment to help meet the needs of hospitals facing additional healthcare costs linked to a rapid increase of antimicrobial resistant organisms,” said Anders Ekblom, Executive Vice President of Global Medicines Development at AstraZeneca.

Marco Taglietti, MD, Senior Vice President Research & Development, Forest Laboratories and President, Forest Research Institute, said: “We are pleased to move forward with the CAZ-AVI development programme. This combination of a broad-spectrum cephalosporin and a novel beta-lactamase inhibitor has the potential to be effective against bacteria that would otherwise be resistant to antibiotics in patients suffering from serious and potentially life-threatening infections.”

This study programme is designed to support global regulatory filings planned for 2014.

As part of the collaboration, development costs of the treatment will be shared between AstraZeneca and Forest. Forest will have the rights to commercialise CAZ-AVI in North America while AstraZeneca will have rights to commercialise CAZ-AVI in the rest of the world.