cUTI (complicated urinary tract infection)
cIAI (complicated intra abdominal infection)
HABP/VABP (hospital-acquired / ventilator-associated bacterial pneumonia)
Ceftolozane/tazabactam Fact Sheet
Ceftolozane/tazobactam (CXA-201), which is being developed as a first-line intravenous therapy for the treatment of certain serious Gram-negative bacterial infections, including those caused by multi-drug resistant Pseudomonas aeruginosa, advanced into Phase 3 trials in 2011 for complicated Urinary Tract Infections (cUTI) and complicated intra-abdominal infections (cIAI).
Cubist estimates peak year sales for ceftolozane/tazobactam, assuming approval in planned indications, of at least $1 billion for the U.S. and EU markets combined. Ceftolozane/tazobactam is being developed for the treatment of infections caused by Gram-negative pathogens including multi-drug resistant Pseudomonas aeruginosa, E. coli, and Klebsiella pneumonia. Ceftolozane/tazobactam is an intravenously administered combination consisting of ceftolozane, a novel, bactericidal cephalosporin with broad Gram-negative activity and potent activity against Pseudomonas aeruginosa, along with tazobactam, a well-known beta-lactamase inhibitor that is a component of the long-established antibiotic, Zosyn®. Before human trials were initiated much was known about the potential of ceftolozane/tazobactam.
Assuming success in its Phase 3 program, Cubist plans to submit an initial New Drug Application (NDA) for the cUTI and cIAI indications within six months, with submission to the EMA shortly thereafter. Subsequently Cubist anticipates submitting for marketing approval the nosocomial pneumonia indication in both the U.S. and the EU.