Cubist to Present New Antibiotics Pipeline Data at 2014 European Congress of Clinical Microbiology & Infectious Diseases (ECC...
April 30 2014 - 10:07AM
Business Wire
First look at detailed data from the
ceftolozane/tazobactam Phase 3 clinical trials in complicated
urinary tract and intra-abdominal infections
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that
it will present data from its late-stage antibiotics pipeline at
the 24th European Congress of Clinical Microbiology and Infectious
Diseases (ECCMID) in Barcelona, May 10-13. Data highlighted will
offer insights into Cubist’s research and development programs,
which focus on Gram-positive and Gram-negative bacteria that cause
serious and complicated infections. Presentations will include the
first detailed results from the pivotal Phase 3 clinical trials of
the Company’s investigational antibiotic ceftolozane/tazobactam
being developed to treat complicated urinary tract infections and
complicated intra-abdominal infections.
“We are excited to present new data at ECCMID on our
investigational treatments that target a wide range of
Gram-positive and Gram-negative bacteria,” said Steven Gilman,
Ph.D., Executive Vice President of Research and Development and
Chief Scientific Officer of Cubist Pharmaceuticals. “Collectively,
the data in 42 posters or presentations demonstrate the depth and
breadth of our portfolio and advancing pipeline to combat drug
resistant bacterial infections that have become recognized global
public health threats.”
Highlights include:
SIVEXTRO™ (tedizolid phosphate):
- Oral session: Comparison of
the microbiological efficacy of tedizolid and linezolid in the
ESTABLISH-1 and ESTABLISH-2 Phase 3 clinical trials
- Abstract/program number: O154
- Presenter: Carisa De Anda, Cubist
- Authors: De Anda C.; Fang E.; Das A.;
Prokocimer P.
- Session: New antibiotics in clinical
trials, May 12, 15:06 CEST, Hall D
- ePoster: Concordance between
early and late response in ESTABLISH-1 and ESTABLISH-2: pooled
results from two Phase 3 trials in acute bacterial skin and skin
structure infections
- Abstract/program number: eP434
- Presenter: Edward Fang, Cubist
- Authors: Fang E.; De Anda C.; Das A.;
Prokocimer P.
- Session: New and not so new
antibiotics, May 10-13, 09:00-17:30 CEST, viewing stations
Ceftolozane/tazobactam:
- Late-breaker: Efficacy and safety of
ceftolozane/tazobactam versus meropenem in the treatment of
complicated intra-abdominal infections (cIAI) in hospitalised
adults: Results from the Phase 3 ASPECT-cIAI
- Abstract/program number: P0266-a
- Presenter: Christian Eckmann , Academic
Hospital of Medical University, Hannover, Germany
- Authors: Eckmann C.; Hershberger E.;
Miller B.; Wooley M.; Friedland I.; Steenbergen J.; Collins S.;
Yuan G.; Barie P.; Solomkin J.
- Session: Antibiotic choices: Clinical
studies, May 10, 15:30-16:30 CEST, poster area
- ePoster: Efficacy and safety
of ceftolozane/tazobactam versus levofloxacin in the treatment of
complicated urinary tract infections (cUTI)/pyelonephritis in
hospitalised adults: Results from the Phase 3 ASPECT-cUTI trial
- Abstract/program number: eP449
- Presenter: Florian Wagenlehner, Justus
Liebig University, Geissen, Germany
- Authors: Wagenlehner F.; Umeh O.;
Huntington J.; Cloutier D.; Friedland I.; Steenbergen J.; Yuan G.;
Yoon M.; Darouiche R.
- Session: New and old beta-lactamase
inhibitors, May 10-13, 09:00-17:30 CEST, viewing stations
- ePoster:
Ceftolozane/tazobactam activity against Gram-negative bacteria
causing intra-abdominal infections in European hospitals
(2011-2012): A report from an international antimicrobial
surveillance programme
- Abstract/program number: eP446
- Presenter: Sandra McCurdy, Cubist
- Authors: McCurdy S.; Petersen P.J.;
Steenbergen J.; Farrell D.J.; Bassetti M.
- Session: New and old beta-lactamase
inhibitors, May 10-13, 09:00-17:30 CEST, viewing stations
- ePoster:
Ceftolozane/tazobactam activity against Gram-negative bacteria
causing urinary tract infections in European hospitals (2011-2012):
A report from an international antimicrobial surveillance
programme
- Abstract/program number: eP445
- Presenter: Sandra McCurdy, Cubist
- Authors: McCurdy S.; Petersen P.J.;
Steenbergen J.; Farrell D.J.; Bassetti M.
- Session: New and old beta-lactamase
inhibitors, May 10-13, 09:00-17:30 CEST, viewing stations
Surotomycin:
- Poster presentation:
Antibiotic susceptibility of surotomycin and five other
antibiotics against Clostridium difficile isolates, collected at a
pan-European survey in 2008 (n=119)
- Abstract/program number: P0792
- Presenter: Ed J. Kuijper, Leiden
University Medical Center, Leiden, Netherlands
- Authors: Sanders I.M.; Harmanus C.;
Debast S.; Kuijper E.J.
- Session: C. difficile: antimicrobial
susceptibility and treatment, May 11, 13:30-14:30 CEST, poster
area
- Poster presentation: In
vitro activity of surotomycin (formerly CB-183,315) against
126 clinical isolates of Clostridium difficile
- Abstract/program number: P0805
- Presenter: Frédéric Barbut, Université
Pierre et Marie Curie, Paris, France
- Authors: Valentin O.; Eckert C.;
Chesnel L.; Barbut F.
- Session: C. difficile: antimicrobial
susceptibility and treatment, May 11, 13:30 – 14:30 CEST, poster
area
A full list of Cubist sessions, including symposia addressing
Gram-positive organisms and Gram-negative infections, is available
on the ECCMID website here. For more information about ECCMID
visit: http://www.eccmid.org/
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: the anticipated
timing for presenting data related to our pipeline and portfolio of
product candidates and products; the therapeutic potential of
ceftolozane/tazobactam, SIVEXTRO and our other product candidates
and portfolio assets; results from our Phase 3 clinical trials of
ceftolozane/tazobactam and SIVEXTRO; our aspirations to achieve a
portion of the IDSA goal of 10 new antibiotics by 2020; and the
level of our financial and personnel commitments towards antibiotic
research, development and commercialization, 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 accept for filing, or approve on a timely basis or at all,
our marketing approval applications for ceftolozane/tazobactam and
SIVEXTRO (tedizolid phosphate), may not agree with our
interpretation of the results from the clinical studies of
ceftolozane/tazobactam and SIVEXTRO, 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 and SIVEXTRO may impose
significant limitations on its use and additional post-marketing
requirements; our ability to obtain adequate pricing and
reimbursement levels for ceftolozane/tazobactam and SIVEXTRO; our
ability to successfully commercialize ceftolozane/tazobactam and
SIVEXTRO, including as a result of regulatory authorities’
decisions regarding labeling and other matters, including adverse
side effects, that could affect its availability or commercial
potential; our ability to maintain and enforce intellectual
property protection for ceftolozane/tazobactam, SIVEXTRO and our
other portfolio assets; competitive risks from current and future
therapeutic alternatives to ceftolozane/tazobactam, SIVEXTRO and
our other portfolio assets; additional clinical trials of
ceftolozane/tazobactam, SIVEXTRO and our other portfolio assets may
not be successful or initiated or conducted in a timely manner;
technical difficulties or excessive costs relating to the
manufacture or supply of ceftolozane/tazobactam, SIVEXTRO and our
other portfolio assets, including our ability to work with our
third party contract manufacturers that manufacture and supply
ceftolozane/tazobactam, SIVEXTRO and our other portfolio assets on
our behalf; our ability to work with, and the performance of our
third party contract research organizations that help us conduct
our clinical trials; we may encounter other unanticipated or
unexpected risks with respect to the development or manufacture of
ceftolozane/tazobactam, SIVEXTRO and our other portfolio assets;
our ability to achieve our strategic goals, including as a result
of our ability to continue to grow revenues from the sale of
CUBICIN® (daptomycin for injection), DIFICID® (fidaxomicin) and
ENTEREG® (alvimopan), generic and other competition, manufacturing
issues, our ability to successfully develop, gain marketing
approval for and commercially launch our product candidates for
their planned indications and on their expected timelines, and 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 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.
INVESTORS:Cubist Pharmaceuticals,
Inc.Eileen C. McIntyre, 781-860-8533Vice President, Investor
Relationseileen.mcintyre@cubist.comorMEDIA:Cubist Pharmaceuticals, Inc.US
Media:Jennifer Baird, 781-860-1282Mobile: 781-708-2309Director of
Product Communicationsjennifer.baird@cubist.comorEurope Media:Weber
ShandwickNivey Nocher, +44 (0) 207 067 0143Mobile: +44 (0)
779-617-5609Account Director, Healthnnocher@webershandwick.com