AstraZeneca and Forest Laboratories starts phase III of Ceftazidime/Avibactam clinical trials to treat serious infections caused by gram negative bacteria.

This curriculum will include five trials phase III designed to demonstrate that CAZ-AVI is an effective and well tolerated treatment for patients with IIAc and ITUc including patients with infections that may be resistant to available antibiotics today.

This curriculum has been developed on the basis of the results of two individual phase II trials on CAZ-AVI:

-the trial phase II in IIAc showed that the effectiveness of CAZ-AVI administered metronidazole in adult patients was similar to meropenem, an established treatment given to patients with complicated intra-abdominal infections

-the trial phase II in Fusagasugá showed that the efficacy of CAZ-AVI in adult patients was similar to imipenem, cilastatinan established treatment given to patients with complicated urinary tract infections

-data from both trials showed that in general CAZ-AVI is tolerated well

this new step in the development of CAZ-AVI demonstrates our commitment to help meet the needs of hospitals who face additional health care costs linked to the rapid rise of antimicrobial-resistant microorganisms ”, said Anders Ekblom, Executive Vice President of Global Medicines Development (Global development of medicines) of AstraZeneca.

Dr. Marco Taglietti, Executive Vice President of research and development of Forest Laboratories and President of the Forest Research Institute, said: we are pleased to move forward with the agenda for development of CAZ-AVI. This combination of a broad-spectrum cephalosporin and a novel inhibitor of beta-lactamases has the potential to be effective against bacteria that otherwise would be resistant to antibiotics in patients with serious and life-threatening infections ”.

This curriculum is designed to endorse her international application of the marketing authorisation for scheduled for 2014.

As part of the collaboration, AstraZeneca and Forest will share the costs of the development of the treatment. Forest will take CAZ-AVI marketing rights in North America while AstraZeneca CAZ-AVI marketing rights in the rest of the world.

Phase III study program

development phase III scheduled program is designed to demonstrate that CAZ-AVI is an effective and well tolerated treatment for use in patients with infections caused by gram-negative, IIAc / or Fusagasugá, including those in which they are known or are suspected pathogens resistant to antibiotics normally used (such as the Enterobacteriaceae producing beta-lactamases of spectrum spread resistance to Penicillins and cephalosporins third grammar)(n).

studies phase II

complicated intra-abdominal infections (IIAc). This test phase II was a double blind, randomized study, prospective to estimate the efficacy, safety and tolerability of CAZ-AVI administered metronidazole to meropenem in the treatment of 203 adults hospitalized with IIAC requiring treatment with an intravenous antimicrobial. Patients treated with CAZ-AVI administered metronidazole had a high rate of clinical response (91.2% of patients) that was similar to that obtained in patients treated with meropenem (93.4% of patients)

complicated infections of the urinary tract (ITUc). This test phase II was a single-blind (for researchers), randomized, prospective to estimate the efficacy, safety and tolerability of CAZ-AVI to imipenem/cilastatin in the treatment of 135 adults hospitalized with Fusagasugá requiring treatment with an intravenous antimicrobial. Patients treated with CAZ-AVI had a high rate of complete eradication of pathogens (70.4% of patients) that was similar to that obtained in the patients treated with imipenem/cilastatin (71.4% of patients).

AstraZeneca collaboration/Forest in CAZ-AVI

In December 2009, AstraZeneca signed a contract to acquire Novexel, a private research of infections in France company at the same time announcing an agreement for collaboration with Forest Laboratories in the future co-development and commercialization of two antibiotics in late stage development programmes: ceftazidime/avibactam and ceftarolina fosamil/avibactam. These combinations of antibiotics used avibactam, novel experimental beta-lactamases of Novexel inhibitor, to overcome the resistance to antibiotics and deal with the increasing number of infections resistant to current treatments. AstraZeneca and Forest will share the costs of the development of CAZ-AVI.

About Forest Laboratories

International associations of Forest Laboratories (NYSE: FRX) and his career in the development and commercialization of pharmaceutical products in the United States, have culminated in its well-established franchises of cardiovascular and central nervous system and innovations in anti-infecciosa and respiratory medicine. The product portfolio in phase of development of the company, the more solid in its history, includes product candidates at all stages of development in a wide variety of therapeutic areas. The company is headquartered in New York, NY.

About AstraZeneca

AstraZeneca is an innovative company biopharmaceutical global focused mainly on the discovery, development and commercialization of prescription for the areas of gastrointestinal drugs, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious diseases. AstraZeneca operates in over 100 countries and their innovative medicines used by millions of patients around the world.