Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that it will focus on its expanded pipeline of antibiotics, represented through several presentations, during IDWeek 2013 being held October 2-6 in San Francisco. Presentations will feature the company’s development of antibiotics for serious infections caused by multidrug-resistant bacteria. Several presentations will also highlight the marketed antibiotic CUBICIN® (daptomycin for injection). Presentations at IDWeek will focus on the company’s late stage candidates ceftolozane/tazobactam (formerly CXA-201) being studied for the treatment of Gram-negative bacteria and surotomycin (formerly CB-183,815) being studied for the treatment of diarrhea caused by Clostridium difficile (C. difficile), categorized as an urgent threat in the recent U.S. Centers for Disease Control and Prevention (CDC) report “Antibiotic Resistant Threats in the United States, 2013.” Presentations will also feature tedizolid phosphate, a once daily, I.V. or orally administered oxazolidinone being developed for the treatment of serious Gram-positive skin infections, including those caused by methicillin-resistant Staphylococcus aureus (MRSA). In addition, Cubist expects to begin trials with tedizolid phosphate in gram-positive lung infections later this year. Cubist has added tedizolid to its pipeline through the recent acquisition of Trius Therapeutics. All of these candidates have been granted Fast Track status, pursuant to the GAIN Act, by the U.S. Food and Drug Administration (FDA) for their respective Qualified Infectious Disease Product (QIDP) indications. “With the recent acquisition of Trius, Cubist is making significant traction towards meeting the IDSA challenge to industry and policy makers to develop and approve 10 new antibiotics by 2020. We are keenly focused on combatting growing antibacterial resistance and rising hospital-acquired infections,” said Steven Gilman, Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer of Cubist Pharmaceuticals. “Our presentations will focus on our expanded pipeline, which includes antibiotics being developed to address pathogens contributing to the escalating global public health threat. During IDWeek we are also marking the 10 year anniversary of CUBICIN, which was developed and launched by Cubist.”
A list of selected presentations can be reviewed in A Guide to Sessions for Cubist Investors. Highlights include several posters that will be presented in Moscone Center Hall C during the meeting:CUBICIN (daptomycin for injection): CUBICIN is approved in the U.S. for the treatment of complicated skin and skin structure infections (cSSSI) caused by susceptible strains of certain Gram-positive microorganisms and S. aureus bloodstream infections (bacteremia), including those with right-sided infective endocarditis, caused by methicillin-susceptible (MSSA) and methicillin-resistant (MRSA) isolates. CUBICIN is the only once-daily I.V. bactericidal antibiotic approved in the U.S. for both MRSA cSSSI and bacteremia. Six Cubist funded daptomycin abstracts will be presented at the meeting, including long-term global surveillance of daptomycin and daptomycin outcomes in MRSA bacteremia with vancomycin MICs > 1 mg/L, and the use of daptomycin in patients with HIV and in pediatric patients, which will be reported. Other non-Cubist funded abstracts related to daptomycin will be presented. Cubist-funded presentations include:
- Evaluation of Daptomycin Activity Tested Against 164,459 Bacterial Strains from Hospitalized Patients: Summary of 8 Years of Surveillance Program Worldwide (2005-2012) (Poster 753), Friday, October 4, 12:30 p.m – 2:00 p.m.
- Effectiveness of Daptomycin (D) for MRSA Bloodstream Infections (BSI) with Vancomycin (V) MIC 1.5-2.0 mg/L: A Multi-center Evaluation of Clinical and Microbiology Outcomes (Poster 1732), Saturday, October 5, 12:30 p.m. – 2:00 p.m.
- Pharmacokinetics of Tedizolid in Adolescents and Elderly Subjects and Subjects with Renal or Hepatic Impairment (Poster 707), Friday, October 4, 12:30 p.m. – 2:00 p.m.
- Impact of Different Methods of Lesion Size Measurement on the Clinical Outcome in Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Clinical Trials (Poster 813), Friday, October 4, 12:30 p.m. - 2:00 p.m.
- Reliability and Reproducibility of Lesion Size Measurements in Patients with Skin Abscesses or Cellulitis (Poster 1342), Saturday, October 5, 12:30 p.m. - 2:00 p.m.
- Correlation of Lesion Size Changes and Pain in Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Clinical Trials: Reflecting How Patients Feel (Poster 1341), Saturday, October 5, 12:30 p.m. - 2:00 p.m.
- Antimicrobial Activity of Ceftolozane/Tazobactam and Comparator Agents Tested Against Pseudomonas aeruginosa Isolated from United States (USA) Medical Centers (2011-2012) (Poster 695), Friday, October 4, 12:30 p.m. - 2:00 p.m.
- Ceftolozane/Tazobactam Activity Tested Against Aerobic Gram-negative Organisms Isolated from Intra-abdominal Infections (IAIs) in European and United States Hospitals (2012) (Poster 698), Friday, October 4, 12:30 p.m. – 2:00 p.m.
- Frequency of Occurrence and Antimicrobial Susceptibility of Gram-negative Organisms Isolated from Health Care-associated (HCA) Urinary Tract Infections (UTI): Results from the Program to Assess Ceftolozane/Tazobactam Susceptibility (PACTS) (Poster 699), Friday, October 4, 12:30 p.m. – 2:00 p.m.
- Prevalence of antibiotic resistance among P. aeruginosa in US hospitals, 2000-2009 (Poster 1580), Saturday, October 5, 12:30 p.m. – 2:00 p.m.
- Pharmacokinetics of Surotomycin from a Phase 1 Single Ascending Dose Study in Healthy Volunteers (Poster 716), Friday, October 4, 12:30 p.m. – 2:00 p.m.
- Pharmacokinetics of Surotomycin from a Phase 1 Multiple Ascending Dose Study in Healthy Volunteers (Poster 719), Friday, October 4, 12:30 p.m. – 2:00 p.m.
About IDWeek 2013IDWeek is the combined 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 will be held in the Moscone Convention Center, 747 Howard Street, San Francisco, CA 94103, October 2-6, 2013. For more information, visit www.idweek.org. Forward Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein which do not describe historical facts, including but not limited to, statements regarding: the therapeutic and commercial potential of our products and product candidates, including CUBICIN, tedizolid, ceftolozane/tazobactam and surotomycin; the expected timing of beginning trials with tedizolid phosphate in gram-positive lung infections; and our progress towards meeting the IDSA challenge to develop and approve 10 new antibiotics by 2020, 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: the fact that drug development involves a high degree of risk and a high rate of failure and success in pre-clinical studies or early stage clinical trials does not mean that later stage trials will be successful; clinical trials of our products and product candidates may not begin or be conducted on timelines that we expect and 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; that 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; acceptance, review and approval decisions for new drug applications by regulatory authorities is an uncertain and evolving process and regulatory authorities retain significant discretion at all stages of the review and approval process; if approved, the commercial market for our product candidates may not be as large as we anticipate, including as a result of competing with products currently in development which may have superior efficacy, safety or product profiles as our product candidates; technical difficulties or excessive costs relating to the manufacture or supply of our products and product candidates, including our dependence on and the performance of our third party contract manufacturers that manufacture and supply our products and product candidates on our behalf; we may not be able to maintain and enforce the intellectual property protecting our products and product candidates; and those additional factors discussed under the caption “Risk Factors” in our and Trius Therapeutics, Inc.’s most recent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission.