Powered by Business Wire
Biotechnology Headlines

Cubist to Present New Data from Antibiotics Portfolio at 54th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC)

ICAAC 2014

LEXINGTON, Mass.--(BUSINESS WIRE)--Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that it will present new data at the 54th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), September 5-9 in Washington, D.C. Data highlighted will offer insights into Cubist’s commitment to identifying treatments for drug-resistant Gram-positive and Gram-negative bacteria that cause serious infections.

“We look forward to participating in this year’s ICAAC meeting and sharing new data from our ongoing surveillance and clinical trial programs, including marketed SIVEXTRO™ and investigational compound ceftolozane/tazobactam”

Noteworthy presentations will include data on SIVEXTRO™ (tedizolid phosphate), recently approved by the United States Food and Drug Administration (FDA) for acute bacterial skin and skin structure infections (ABSSSI), and data on the company’s investigational antibiotic ceftolozane/tazobactam. Ceftolozane/tazobactam is under review by the U.S. Food and Drug Administration for the treatment of complicated urinary tract infections and complicated intra-abdominal infections and has an FDA action date of December 21, 2014.

“We look forward to participating in this year’s ICAAC meeting and sharing new data from our ongoing surveillance and clinical trial programs, including marketed SIVEXTRO™ and investigational compound ceftolozane/tazobactam,” said Steven Gilman, Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer of Cubist Pharmaceuticals. “Continuous monitoring of resistance trends is key to staying in front of the organisms that cause infections.”

Highlights include:

SIVEXTRO™ (tedizolid phosphate):

  • Poster: Efficacy of tedizolid and linezolid in acute bacterial skin and skin structure infections caused by Staphylococcus aureus—pooled analysis of two Phase 3 trials
    • Abstract/program number: Poster L-1732
    • Presenter: C. DeAnda, Vice President, Clinical, Cubist Pharmaceuticals
    • Session: Clinical Studies in Skin and Skin Structure Infections; Monday, September 8, 11:00 a.m.-1:00 p.m. EDT, Exhibit Hall B
  • Poster: Clinical response with tedizolid versus linezolid by infection type and lesion size/location: a pooled analysis of two Phase 3 acute bacterial skin and skin structure infection studies
    • Abstract/program number: Poster L-1733
    • Presenter: C. DeAnda, Vice President, Clinical, Cubist Pharmaceuticals
    • Session: Clinical Studies in Skin and Skin Structure Infections; Monday, September 8, 11:00 a.m.-1:00 p.m. EDT, Exhibit Hall B
  • Poster: Susceptibility testing of a novel oxazolidinone, tedizolid, using linezolid as a surrogate agent
    • Abstract/program number: Poster F-1607
    • Presenter: G. Zurenko, ZML Consulting, Kalamazoo, MI
    • Session: New Spins on Protein Synthesis Inhibitors; Monday, September 8, 11:00 a.m.-1:00 p.m. EDT, Exhibit Hall B
  • Poster: Results of the Surveillance of Tedizolid Activity and Resistance (STAR) program: in vitro susceptibility of Gram-positive pathogens collected in 2009 to 2012 from the United States and Europe
    • Abstract/program number: Poster C-829
    • Presenter: Paul A. Bien, MS, Cubist Pharmaceuticals
    • Session: Susceptibility to Newer Anti Gram-Positive Molecules; Sunday, September 7, 11:00 a.m.-1:00 p.m. EDT, Exhibit Hall B

Ceftolozane/tazobactam:

  • Poster: Antimicrobial activity of ceftolozane/tazobactam and comparator agents tested against Pseudomonas aeruginosa isolates from United States medical centers (2013)
    • Abstract/program number: Poster C-771
    • Presenter: David J. Farrell, JMI Lab., North Liberty, IA
    • Session: Ceftaroline and New Beta-Lactam/Beta-Lactamase Inhibitor Combinations: The Real Efficacy; Sunday, September 7, 11:00 a.m.-1:00 p.m. EDT, Exhibit Hall B
  • Poster: Susceptibility profile of commonly utilized parenteral antimicrobials against E. coli, K. pneumoniae and P. aeruginosa from US hospitals
    • Abstract/program number: Poster C-119
    • Presenter: Christina A. Sutherland, Center for Anti-Infective Research and Development, Hartford Hospital, Hartford, Connecticut
    • Session: Large Scale Epidemiological Surveillances of Multidrug Resistant Bacteria; Saturday, September 6, 12:00 p.m.-2:00 p.m. EDT, Exhibit Hall B
  • Poster: Activity of ceftolozane/tazobactam against isolates of Enterobacteriaceae and P. aeruginosa from US hospitals testing non-susceptible to piperacillin/tazobactam
    • Abstract/program number: Poster C-770
    • Presenter: Christina A. Sutherland, Center for Anti-Infective Research and Development, Hartford Hospital, Hartford, Connecticut
    • Session: Ceftaroline and New Beta-Lactam/Beta-Lactamase Inhibitor Combinations: The Real Efficacy; Sunday, September 7, 11:00 a.m.-1:00 p.m. EDT, Exhibit Hall B
  • Poster: Epidemiology and susceptibility of organisms isolated from patients with cIAI: results from ASPECT‐cIAI
    • Abstract/program number: Poster C-774
    • Presenter: E.S. Armstrong, Cubist Pharmaceuticals
    • Session: Ceftaroline and New Beta-Lactam/Beta-Lactamase Inhibitor Combinations: The Real Efficacy; Sunday, September 7, 11:00 a.m.-1:00 p.m. EDT, Exhibit Hall B
  • Poster: Epidemiology and susceptibility of organisms isolated from patients With cUTI: results from ASPECT‐cUTI
    • Abstract/program number: Poster C-127
    • Presenter: E.S. Armstrong, Cubist Pharmaceuticals
    • Session: Large Scale Epidemiological Surveillances of Multidrug Resistant Bacteria; Saturday, September 6, 12:00 p.m.-2:00 p.m. EDT, Exhibit Hall B

A full list of Cubist sessions, including symposia addressing Gram-positive organisms and Gram-negative infections, is available on the ICAAC website here. For more information about ICAAC visit: http://www.icaac.org/

Indication and Important Safety Information

SIVEXTRO Indication and Usage

  • SIVEXTROTM (tedizolid phosphate) is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-resistant [MRSA] and methicillin-susceptible [MSSA] isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group (including Streptococcus anginosus, Streptococcus intermedius and Streptococcus constellatus), and Enterococcus faecalis.
  • To reduce the development of drug resistant bacteria, only use SIVEXTRO for ABSSSI proven or strongly suspected to be caused by susceptible bacteria through the use of culture and susceptibility information or local epidemiology and susceptibility patterns.

SIVEXTRO Important Safety Information

  • Patients with neutropenia: The safety and efficacy of SIVEXTRO in patients with neutropenia (neutrophil counts <1000 cells/mm3) have not been adequately evaluated. In an animal model of infection, the antibacterial activity of SIVEXTRO was reduced in the absence of granulocytes. Alternative therapies should be considered when treating patients with neutropenia.
  • Clostridium difficile–associated diarrhea (CDAD), ranging from mild diarrhea to fatal colitis, has been reported with nearly all systemic antibacterial agents, including SIVEXTRO. Careful medical history is necessary because CDAD has been reported to occur more than two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, antibacterial use not directed against C. difficile should be discontinued.
  • Development of drug-resistant bacteria: Prescribing SIVEXTRO in the absence of a proven or strongly suspected bacterial infection or prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug resistant bacteria.
  • Adverse Reactions: The most common adverse reactions for SIVEXTRO are nausea, headache, diarrhea, vomiting, and dizziness.

About Cubist’s Commitment to Antibiotic R&D

Cubist has a growing commitment to global public health through its leadership in the discovery, development and commercialization of novel antibiotics to treat serious and life-threatening infections caused by a broad range of increasingly drug-resistant bacteria. The Company hopes to deliver at least four new antibiotics in support of the Infectious Diseases Society of America (IDSA) goal of 10 new antibiotics by 2020. Cubist expects to invest approximately $400M USD in 2014 on antibacterial R&D and approximately 75% of its employee base is focused on the research, development, commercialization and support of antibiotics.

About Cubist

Cubist Pharmaceuticals, Inc. is a global 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, Massachusetts, with a central international office located in Zurich, Switzerland. Additional information can be found at Cubist’s web site at www.cubist.com. Also, connect with Cubist on Twitter @cubistbiopharma and @cubistcareers, LinkedIn, or YouTube.

Forward Looking Statements

This press release contains forward-looking statements. Any statements contained herein which do not describe historical facts, including but not limited to, statements regarding: our commitment to identifying treatments for drug-resistant Gram-positive and Gram-negative bacteria that cause serious infections, and that ceftolozane/tazobactam has an FDA action date of December 21, 2014, are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements. Such risks and uncertainties include, among others: regulatory developments, including the risk that the U.S. Food and Drug Administration and other regulatory authorities may not approve or approve on a timely basis, our marketing approval application for ceftolozane/tazobactam, may not agree with our interpretation of the results from the clinical studies of ceftolozane/tazobactam, or may require additional data, analysis, information or further studies that may not be clinically feasible or financially practicable; any marketing approval for ceftolozane/tazobactam may impose significant limitations on its use and additional post-marketing requirements; technical difficulties or excessive costs relating to the manufacture or supply of ceftolozane/tazobactam; we may encounter other unanticipated or unexpected risks with respect to the development or manufacture of ceftolozane/tazobactam and our other portfolio assets; our ability to discover, in-license or acquire new products and product candidates; and those additional factors discussed in our most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q filed with the Securities and Exchange Commission. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. These forward-looking statements speak only as of the date of this press release, and we undertake no obligation to update or revise any of these statements.

Contacts

Cubist Pharmaceuticals, Inc.
INVESTORS:
Eileen C. McIntyre, 781-860-8533
Vice President, Investor Relations
eileen.mcintyre@cubist.com
or
MEDIA:
Elizabeth Dunavant, 781-860-8680
Mobile: (312) 545-8924
Director, Product Communications
elizabeth.dunavant@cubist.com