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&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 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 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: 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.