Cubist to Present New Data on Antibiotics Portfolio at IDWeek 2014
September 30 2014 - 8:30AM
Business Wire
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that
it will present new data from its antibiotics portfolio at IDWeek
2014, October 8-12, in Philadelphia, PA. Presentations of these
data are important as new antibiotics are needed for the growing
global public health issue of serious and sometimes
life-threatening 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, which is under
review by the FDA for the treatment of complicated urinary tract
infections and complicated intra-abdominal infections.
Ceftolozane/tazobactam has an FDA action date of December 21, 2014.
Other presentations will highlight the marketed antibiotics
CUBICIN® (daptomycin) and DIFICID® (fidaxomicin).
“Cubist is committed to developing antibiotics to address
serious infections, including those caused by 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. “Cubist’s efforts in antibiotic research
and development will contribute at least four antibiotics in
support of the Infectious Diseases Society of America challenge to
industry and policy makers to develop and approve 10 new
antibiotics by 2020.”
Highlights include:
DIFICID® (fidaxomicin):
- Late Breaker: A Safety and
Pharmacokinetic Study of Fidaxomicin in Children with Clostridium
difficile-associated diarrhea
- Abstract/program number: LB-8
- Presenter: Pam Sears, Vice President,
Clinical Sciences, Cubist
- Session: Late Breaker Oral Abstracts;
Saturday, October 11, 10:30 a.m.-12:00 p.m. EDT, The Pennsylvania
Convention Center: 105-AB
- Poster: C. difficile recurrence is a
strong predictor of 30-day rehospitalization among ICU patients
- Abstract/program number: Poster
1658
- Presenter: Marya D. Zilberberg, MD,
MPH, University of Massachusetts and Evimed Research Group, LLC,
Goshen, MA
- Session: Poster Abstract Session:
Clostridium difficile Infection: Epidemiology, Presentation,
Treatment; Saturday, October 11, 12:30 p.m.-2:00 p.m. EDT, IDExpo
Hall BC
SIVEXTRO™ (tedizolid phosphate):
- Poster: Comparison of the hematologic safety of tedizolid &
linezolid: pooled results from two Phase 3 trials in acute
bacterial skin and skin structure infections
- Abstract/program number: Poster
269
- Presenter: C. DeAnda, Vice
President, Clinical, Cubist Pharmaceuticals
- Session: Poster Abstract Session:
Antimicrobial Resistance: Novel Agents and Approaches to
Gram-Positive Infections, Thursday, October 9, 12:30 p.m.-2:00 p.m.
EDT, IDExpo Hall BC
- Poster: Gastrointestinal safety profile of tedizolid: pooled
results from two Phase 3 trials in ABSSSI
- Abstract/program number: Poster
263
- Presenter: C. DeAnda, Vice
President, Clinical, Cubist Pharmaceuticals
- Session: Poster Abstract Session:
Antimicrobial Resistance: Novel Agents and Approaches to
Gram-Positive Infections; Thursday, October 9, 12:30 p.m.-2:00 p.m.
EDT, IDExpo Hall BC
- Poster: Results of the Surveillance of Tedizolid Activity and
Resistance (STAR) program: in vitro susceptibility of Gram-positive
clinical isolates collected in 2013 from the United
States
- Abstract/program number: Poster
264
- Presenter: Paul A. Bien, MS, Cubist
Pharmaceuticals
- Session: Poster Abstract Session:
Antimicrobial Resistance: Novel Agents and Approaches to
Gram-Positive Infections; Thursday, October 9, 12:30 p.m.-2:00 p.m.
EDT, IDExpo Hall BC
Ceftolozane/tazobactam:
- Poster: An
international, multicenter, retrospective study of nosocomial
pneumonia due to Pseudomonas aeruginosa
- Abstract/program number: Poster
339
- Presenter: Scott Micek, Pharm.D., FCCP,
BCPS, Pharmacy Practice, St. Louis College of Pharmacy, St. Louis,
MO
- Session: Poster Abstract Session:
Multidrug-resistant Organisms: Epidemiology and Prevention;
Thursday, October 9, 12:30 p.m.-2:00 p.m. EDT, IDExpo Hall BC
- Poster: Efficacy of ceftolozane/tazobactam versus levofloxacin in
the treatment of complicated urinary tract infections caused by
levofloxacin‐resistant pathogens: results from the ASPECT‐cUTI
trial
- Abstract/program number: Poster
1044
- Presenter: George Sakoulas, MD,
Department of Pediatrics, University of California San Diego School
of Medicine, San Diego, CA
- Session: Poster Abstract Session: UTIs:
Management and Issues in Drug-Resistance; Friday, October 10, 12:30
p.m.-2:00 p.m. EDT, IDExpo Hall BC
- Poster: Ceftolozane/tazobactam for the treatment of cUTI and cIAI
caused by ESBL-producing Enterobacteriaceae
- Abstract/program number: Poster
260
- Presenter: Myra C. Popejoy, PharmD,
Cubist Pharmaceuticals
- Session: Poster Abstract Session:
Antimicrobial Resistance: Novel Agents and Approaches to Gram
Negative Infections; Thursday, October 9, 12:30 p.m.-2:00 p.m. EDT,
IDExpo Hall BC
- Poster: Characteristics and outcomes of complicated
intra-abdominal infections involving Pseudomonas aeruginosa from a
Phase 3 ceftolozane/tazobactam study
- Abstract/program number: Poster
251
- Presenter: Benjamin Miller, PharmD,
Cubist Pharmaceuticals
- Session: Poster Abstract Session:
Antimicrobial Resistance: Novel Agents and Approaches to Gram
Negative Infections; Thursday, October 9, 12:30 p.m.-2:00 p.m. EDT,
IDExpo Hall BC
CUBICIN® (daptomycin):
- Poster: Comparative effectiveness of vancomycin versus early
daptomycin for MRSA bacteremia with vancomycin MIC >1 mg/L: a
multicenter evaluation
- Abstract/program number: Poster
673
- Presenter: Pamela Moise, PharmD, Cubist
Pharmaceuticals
- Session: Poster Abstract Session:
Approach to Clinical Infections; Friday, October 10, 12:30
p.m.-2:00 p.m. EDT, IDExpo Hall BC
A full list of Cubist sessions, including symposia addressing
Gram-positive organisms and Gram-negative infections, is available
on the IDWeek 2014 website here. For more information about IDWeek
2014 visit: http://www.idweek.org/.
Indication and Important Safety Information
DIFICD Indication and Usage
- DIFICID® (fidaxomicin) is indicated in
adults (≥18 years of age) for treatment of Clostridium
difficile-associated diarrhea (CDAD)
- To reduce the development of
drug-resistant bacteria, DIFICID should be used only to treat
infections that are proven or strongly suspected to be caused by
Clostridium difficile
DIFICD Important Safety Information
- DIFICID should not be used for
systemic infections.
- Acute hypersensitivity reactions
(angioedema, dyspnea, pruritus, and rash) have been reported. In
the event of a severe reaction, discontinue DIFICID
- Development of drug-resistant
bacteria: Prescribing DIFICID in the absence of a proven or
strongly suspected C. difficile infection 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 are nausea (11%), vomiting (7%), abdominal
pain (6%), gastrointestinal hemorrhage (4%), anemia (2%), and
neutropenia (2%)
SIVEXTRO Indication and Usage
- SIVEXTRO™ (tedizolid phosphate) is
indicated for the treatment of adults with 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, if possible
- 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 (>2%) are nausea,
headache, diarrhea, vomiting, and dizziness
CUBICIN Indication and Usage
- CUBICIN® (daptomycin) is indicated for
the treatment of complicated skin and skin structure infections
(cSSSI) caused by susceptible isolates of the following
Gram-positive bacteria: Staphylococcus aureus (including
methicillin-resistant isolates), Streptococcus pyogenes,
Streptococcus agalactiae, Streptococcus dysgalactiae subspecies
equisimilis, and Enterococcus faecalis (vancomycin-susceptible
isolates only); and S. aureus bloodstream infections (bacteremia),
including patients with right-sided infective endocarditis
- CUBICIN is not indicated for the
treatment of left-sided infective endocarditis (LIE) due to S.
aureus. CUBICIN has not been studied in patients with prosthetic
valve endocarditis. CUBICIN is not indicated for the treatment of
pneumonia
CUBICIN Important Safety Information
- Anaphylaxis/hypersensitivity
reactions (including life-threatening). Discontinue CUBICIN and
treat signs/symptoms
- Myopathy and rhabdomyolysis:
Monitor CPK levels and follow muscle pain or weakness; if elevated
CPK or myopathy occurs, consider discontinuation of CUBICIN
- Eosinophilic pneumonia:
Discontinue CUBICIN and consider treatment with systemic
steroids.
- Peripheral neuropathy: Monitor
for neuropathy and consider discontinuation
- 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, if possible
- Persisting or relapsing S. aureus
bacteremia/endocarditis: Perform susceptibility testing and
rule out sequestered foci of infection
- Decreased efficacy was observed in
patients with moderate baseline renal impairment.
- Adverse Reactions: The most
clinically significant adverse reactions observed with CUBICIN 4
mg/kg (cSSSI trials) and 6 mg/kg (S. aureus bacteremia/endocarditis
trial) were abnormal liver function tests, elevated CPK, and
dyspnea
About Cubist’s Commitment to Antibiotic R&DCubist 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 IDWeek 2014™IDWeek 2014™ is an annual meeting of
the Infectious Diseases Society of America (IDSA), the Society for
Healthcare Epidemiology of America (SHEA), the HIV Medicine
Association (HIVMA) and the Pediatric Infectious Diseases Society
(PIDS). With the theme “Advancing Science, Improving Care,” IDWeek
features the latest science and bench-to-bedside approaches in
prevention, diagnosis, treatment, and epidemiology of infectious
diseases, including HIV, across the lifespan. IDWeek 2014 takes
place October 8-12 at the Pennsylvania Convention Center in
Philadelphia, Pennsylvania. The full name of the meeting is IDWeek
2014™. For more information, visit www.idweek.org.
About CubistCubist 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 StatementsThis press release contains
forward-looking statements. Any statements contained herein which
do not describe historical facts, including but not limited to,
statements regarding: presentations of the listed data at IDWeek
2014 are important as new antibiotics are needed for the growing
global public health issue of serious and sometimes
life-threatening infections, our commitment to identifying
treatments for drug-resistant Gram-positive and Gram-negative
bacteria that cause serious infections, including those caused by
Gram-positive and Gram-negative bacteria, 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, 781-860-8680Director,
Product CommunicationsMobile: (312)
545-8924elizabeth.dunavant@cubist.com