Cubist to Present New Data from Study of fidaxomicin in Children with Clostridium Difficile-Associated Diarrhea at IDWeek 2014
08 October 2014 - 1:30PM
Business Wire
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced it
will present new data from a phase 1 safety and pharmacokinetic
study of fidaxomicin in children with Clostridium
difficile-associated diarrhea (CDAD) at IDWeek 2014, being held
October 8-12 in Philadelphia. These new data will be featured as a
late-breaking oral presentation (LB-8, session #186) Saturday,
October 11, 2014, at 10:30 a.m. EDT, given by Pam Sears, Vice
President, Clinical Sciences, Cubist. The presentation will provide
early insight into the safety, pharmacokinetic profile and efficacy
of fidaxomicin in children who have CDAD.
“Children, especially those who have serious underlying medical
conditions, are susceptible to Clostridium difficile-associated
diarrhea, which can be very serious,” said Steven Gilman, Ph.D.,
Executive Vice President of Research and Development and Chief
Scientific Officer of Cubist Pharmaceuticals. “These first data of
fidaxomicin in children are important because they offer the first
insights into a patient population that is typically excluded from
Phase 3 clinical trials.”
This study of fidaxomicin enrolled 38 patients whose ages ranged
from 11 months to 17 years, most of whom had complex underlying
medical issues, including cancer (23.7%) and/or gastrointestinal
disorders (78.9%). Adverse events observed in greater than two
subjects included fever, vomiting, upper abdominal pain and
C-difficile colitis. At least one adverse event was reported in
73.7% of patients. The majority of adverse events were categorized
as mild (44.7%) or moderate (21.1%). Nine severe adverse events
were observed during the course of the study and were not
considered related to fidaxomicin. The pharmacokinetic profile seen
in this study is similar to the profile shown in an adult
population. Although not powered to assess efficacy, the clinical
response observed in the study was 92.1%. The infections recurred
in 28.6% of patients, all but one of whom had a history of
recurrent CDAD.
“This study supports the further evaluation of fidaxomicin in
children with C. difficile-associated diarrhea,” said Pam Sears.
“As CDAD is most often observed in adults, there is much less
information known about the pediatric presentation of the disease,
and we are excited to present the results of our first study on the
treatment of CDAD in children. We hope the results presented at
IDWeek 2014 encourage ongoing dialogue and exchange on this
important topic.”
In addition to this study, Cubist’s other presentations at
IDWeek 2014 will feature the company’s portfolio of antibiotics for
serious infections caused by multidrug-resistant bacteria. 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.
Fidaxomicin is not currently approved for use in pediatric
patients. Fidaxomicin is marketed in the U.S. as DIFICID® for the
treatment of adult CDAD.
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%)
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 potentially
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.
About IDWeek 2014TM
IDWeek 2014TM 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 2014TM. For more information,
visit www.idweek.org.
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 intention
to present data at IDWeek 2014 from a phase 1 study of fidaxomicin
in children with CDAD, including our view that this study supports
further evaluation of fidaxomicin in children with CDAD; our
intention to present at IDWeek 2014 regarding our other
antibiotics; our commitment to identifying treatments for
drug-resistant bacteria that cause serious infections, including
our commitment to global public health in this area; the level of
our financial and personnel commitments towards antibiotic
research, development and commercialization; our aspirations to
achieve a portion of the IDSA goal of 10 new antibiotics by 2020;
and the therapeutic potential of our products, 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: the fact that drug development involves a high degree
of risk and a high rate of failure and success in early stage
clinical trials does not mean that later stage trials will be
successful; regulatory developments in the U.S. and other
countries; the strength of, and our ability to successfully obtain,
maintain and enforce intellectual property protecting our products;
the fact that drug discovery and development is complex, time
consuming, expensive and fraught with a high risk of failure; we
are dependent on our ability to successfully work with, and the
performance of, our third party clinical research organizations
that we significantly rely on to help us conduct clinical trials;
the timing and feasibility of any new clinical trials is dependent
on our ability to successfully work with regulatory authorities,
including the FDA on the design of the trials, among other things;
technical difficulties or excessive costs relating to the
manufacture or supply of our products, including our dependence on
and the performance of our third party contract manufacturers that
manufacture and supply our products on our behalf 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 and available at
www.sec.gov. 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 Kalina, 781-860-8680Director,
Product CommunicationsMobile:
312-545-8924elizabeth.kalina@cubist.com