Cubist to Present New Data on Antibiotics Portfolio at IDWeek 2014

LEXINGTON, Mass.--()--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.

Contacts

Cubist Pharmaceuticals, Inc.
INVESTORS:
Eileen C. McIntyre, 781-860-8533
Vice President, Investor Relations
eileen.mcintyre@cubist.com
or
MEDIA:
Elizabeth Dunavant, 781-860-8680
Director, Product Communications
Mobile: (312) 545-8924
elizabeth.dunavant@cubist.com

Release Summary

Cubist to Present New Data on Antibiotics Portfolio at IDWeek 2014

Contacts

Cubist Pharmaceuticals, Inc.
INVESTORS:
Eileen C. McIntyre, 781-860-8533
Vice President, Investor Relations
eileen.mcintyre@cubist.com
or
MEDIA:
Elizabeth Dunavant, 781-860-8680
Director, Product Communications
Mobile: (312) 545-8924
elizabeth.dunavant@cubist.com