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Cubist Reinforces Its Global Commitment To Addressing Increasing Antibiotic Resistance At ICAAC 2013

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.

SurotomycinSurotomycin is being studied for the treatment of a severe and sometimes life-threatening diarrhea caused by the Gram-positive bacteria Clostridium difficile (C. difficile). Surotomycin, which is an investigational oral antibiotic, is currently being evaluated in Phase 3 clinical trials compared to vancomycin in patients with C. difficile- associated diarrhea (CDAD), also known as C. difficile infection (CDI).
  • 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.

Discovery ProgramsSeveral abstracts on discovery efforts will be presented at the conference, including a focus on Gyrase B inhibitors, which address antibacterial activity against Gram-positive pathogens. Presentations include: Posters F-1223, F-1224, and F-1225, September 12, 11:00 a.m. – 1:00 p.m. Another discovery stage presentation is focused on the development of a novel treatment of bacterial infections produced by A. baumannii, P. aeruginosa, and E. coli: A Novel Family of Natural Products Antibiotics with Broad Spectrum against Gram-negative Pathogens (Poster F-1215) Thursday, September 12, 11:00 a.m. - 1:00 p.m.

CUBICIN (daptomycin for injection):During ICAAC, Cubist is marking the 10 year anniversary of CUBICIN ®. Developed and launched by Cubist, CUBICIN is the only once-daily I.V. bactericidal antibiotic approved in the U.S. (at 4 mg/kg) for the treatment of complicated skin and skin structure infections caused by susceptible strains of certain Gram-positive microorganisms. One presentation related to daptomycin focuses on a surveillance study comparing the epidemiology of CA-MRSA and health-care associated (HA)-MRSA genotypes in Canadian hospitals: Changing Epidemiology of Community-Associated Methicillin-Resistant Staphylococcus aureus (CA-MRSA) in Canadian Hospitals from 2007-2012 (Poster C2-076), Tuesday, September 10, 12:00 – 2:00 p.m.

For information about Gram-positive and Gram-negative bacteria and antibiotic resistance reference: A Guide to Superbugs and Antibiotic Resistance. For information about ICAAC 2013 visit: http://icaac.org/

About CUBICINCUBICIN ® (daptomycin for injection) is approved in the U.S. and many other non-U.S. markets as therapy for Staphylococcus aureus bloodstream infections (bacteremia), including right-sided endocarditis, caused by methicillin-resistant Staphylococcus aureus (MRSA) and methicillin-susceptible Staphylococcus aureus (MSSA), and complicated skin infections caused by certain Gram-positive bacteria, including MRSA. CUBICIN is not indicated for the treatment of pneumonia.

CUBICIN ® Important Safety InformationPatients receiving CUBICIN should be monitored for the development of muscle pain or weakness, particularly of the distal extremities. In patients who receive CUBICIN, CPK levels should be monitored weekly, and more frequently in patients who received recent prior or concomitant therapy with an HMG-CoA reductase inhibitor or in whom elevations in CPK occur during treatment with CUBICIN. The most common adverse events reported in clinical trials were anemia, constipation, diarrhea, nausea, vomiting, injection site reactions, and headache. To reduce the development of drug-resistant bacteria and maintain the effectiveness of CUBICIN, CUBICIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria susceptible to CUBICIN. For full prescribing information, including important safety information, please visit www.cubicin.com.

About The GAIN ActThe GAIN Act, Title VIII (Sections 801 through 806) of the FDASIA, provides pharmaceutical and biotechnology companies with incentives to develop new antibacterial and antifungal drugs for the treatment of life-threatening infectious diseases caused by drug resistant pathogens. Qualifying pathogens are defined by the GAIN Act to include multi-drug resistant Gram-negative bacteria, including Pseudomonas, Acinetobacter, Klebsiella, and Escherichia coli species; resistant Gram-positive pathogens, including methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Staphylococcus aureus and vancomycin-resistant Enterococcus; multi-drug resistant tuberculosis; and Clostridium difficile.

About CubistCubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on the research, development, and commercialization of pharmaceutical products that address significant unmet medical needs in the acute care environment. Cubist is headquartered in Lexington, Mass. Additional information can be found at Cubist’s web site at www.cubist.com.

Cubist and CUBICIN are registered trademarks of Cubist Pharmaceuticals, Inc.

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