Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today reinforced its global commitment to the critical work of developing antibiotics for serious infections caused by multidrug-resistant bacteria, which the company will highlight during the 53 rd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), being held September 10 – 13, 2013 in Denver. Several presentations will feature the company’s late-stage antibiotic candidate for Gram-negative infections ceftolozane/tazobactam (formerly CXA-201), which has been granted Fast Track status by the U.S. Food and Drug Administration (FDA) in the Qualified Infectious Disease Product (QIDP) indications Hospital-Acquired Bacterial Pneumonia (HABP)/Ventilator-Associated Bacterial Pneumonia (VABP), Complicated Urinary Tract Infections (cUTI), and Complicated Intra-Abdominal Infections (cIAI). Presentations during ICAAC will also feature the antibacterial cyclic lipopeptide surotomycin (CB-183,315), which has also been granted Fast Track status as made possible by the GAIN Act. Other presentations will highlight selected research programs, as well as the marketed antibiotic CUBICIN ® (daptomycin for injection). “With antibiotic resistance increasing globally, Cubist is dedicated to developing the tools and drugs for healthcare providers to be able to manage acutely ill patients, including those with serious infections,” said Steven Gilman, Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer of Cubist Pharmaceuticals. “Our presentations at ICAAC represent important therapies in various stages of discovery and development, which include antibiotics that address emerging pathogens, and provide activity against both Gram-negative and Gram-positive bacteria.” A list of selected presentations can be reviewed in A Guide to Sessions for Cubist Investors. Highlights include several posters that will be presented in Exhibit Hall A during the conference: Ceftolozane/tazobactamCeftolozane/tazobactam is an antibacterial currently in Phase 3 trials for the treatment of cUTI, cIAI and HABP/VABP. It is a novel cephalosporin and a well-established β-lactamase inhibitor with activity against Pseudomonas aeruginosa, including drug-resistant strains, and other common Gram-negative pathogens including most ESBL-producing Enterobacteriaceae. This year at ICAAC, 12 studies on ceftolozane/tazobactam will be presented, including results from a Phase 2 clinical trial in cIAI, which led to the initiation of the Phase 3 studies. Presentations include:
- In Vitro Activity of CXA-201 (Ceftolozane/Tazobactam) Against 200 CTX-M Producing Eschericia coli Clinical Isolates (Poster E-1169), Thursday, September 12, 11:00 a.m. - 1:00 p.m.
- A Multicenter, Double-Blind, Randomized Phase 2 Study to Assess the Safety and Efficacy of Ceftolozane/Tazobactam Plus Metronidazole Compared to Meropenem in Adult Patients with Complicated Intra-Abdominal Infections (Poster K-1709), Friday, September 13, 8:30 -10:30 a.m.
- Antimicrobial Activity of Ceftolozane/Tazobactam Tested against Gram-negative Bacterial Isolates from Hospitalized Patients with Pneumonia in United States and European Hospitals (2012) (Poster C2-1633), Friday, September 13, 8:30 – 10:30 a.m.
- During ICAAC, six presentations will feature surotomycin, including the poster session In Vitro Susceptibility Testing and Activity of Surotyomycin against Clostridium difficile Isolates from a Phase 2 Clinical Trial (Poster E-1176), Thursday, September 12, 11:00 a.m. – 1:00 p.m.