Cubist to Present New Data from Antibiotics Portfolio at 54th Interscience Conference on Antimicrobial Agents & Chemotherapy ...
August 26 2014 - 8:30AM
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.
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.
Cubist Pharmaceuticals, Inc.INVESTORS:Eileen C. McIntyre, 781-860-8533Vice
President, Investor
Relationseileen.mcintyre@cubist.comorMEDIA:Elizabeth Dunavant, 781-860-8680Mobile:
(312) 545-8924Director, Product
Communicationselizabeth.dunavant@cubist.com