LEXINGTON, Mass. -- (BUSINESS WIRE) -- 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:
Poster sessions regarding tedizolid phosphate will provide information on its efficacy in the treatment of serious Gram-positive skin infections, including those caused by MRSA, as well as the pharmacokinetics in special populations. Those presentations include:
Ceftolozane/tazobactam is an antibacterial currently in Phase 3 trials for the treatment of Complicated Urinary Tract Infections (cUTI), Complicated Intra-Abdominal Infections (cIAI), and Hospital-Acquired Bacterial Pneumonia (HABP)/Ventilator-Associated Bacterial Pneumonia (VABP). It is a novel cephalosporin and a well-established β-lactamase inhibitor with in vitro activity against Pseudomonas aeruginosa, including drug-resistant strains, and other common Gram-negative pathogens, including most Extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae. During IDWeek, data presented will highlight the in vitro activity of ceftolozane/tazobactam against P. aeruginosa, as well as the prevalence of P. aeruginosa in the hospital setting. Presentations include:
The antibacterial cyclic lipopeptide surotomycin, which is an investigational oral antibiotic, is currently being evaluated in Phase 3 clinical trials compared to vancomycin in patients with C. difficile- associated diarrhea (CDAD), also known as C. difficile infection (CDI). During IDWeek presentations featuring Phase 1 data include:
For information about Gram-positive and Gram-negative bacteria and antibiotic resistance reference A Guide to Superbugs and Antibiotic Resistance and a video on Gram-negative bacteria mechanism of resistance, available in the News & Media section of the Cubist website: http://www.cubist.com/.
CUBICIN® (daptomycin for injection) is approved in the U.S. and many other non-U.S. markets as therapy for Staphylococcus aureus bloodstream infections (bacteremia), including right-sided endocarditis, caused by methicillin-resistant Staphylococcus aureus (MRSA) and methicillin-susceptible Staphylococcus aureus (MSSA), and complicated skin infections caused by certain Gram-positive bacteria, including MRSA. CUBICIN is not indicated for the treatment of pneumonia.
CUBICIN® Important Safety Information
Patients receiving CUBICIN should be monitored for the development of muscle pain or weakness, particularly of the distal extremities. In patients who receive CUBICIN, CPK levels should be monitored weekly, and more frequently in patients who received recent prior or concomitant therapy with an HMG-CoA reductase inhibitor or in whom elevations in CPK occur during treatment with CUBICIN. The most common adverse events reported in clinical trials were anemia, constipation, diarrhea, nausea, vomiting, injection site reactions, and headache. To reduce the development of drug-resistant bacteria and maintain the effectiveness of CUBICIN, CUBICIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria susceptible to CUBICIN. For full prescribing information, including important safety information, please visit www.cubicin.com.
About The GAIN Act
The GAIN Act, Title VIII (Sections 801 through 806) of the FDASIA, provides pharmaceutical and biotechnology companies with incentives to develop new antibacterial and antifungal drugs for the treatment of life-threatening infectious diseases caused by drug resistant pathogens. Qualifying pathogens are defined by the GAIN Act to include multi-drug resistant Gram-negative bacteria, including Pseudomonas, Acinetobacter, Klebsiella, and Escherichia coli species; resistant Gram-positive pathogens, including methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Staphylococcus aureus and vancomycin-resistant Enterococcus; multi-drug resistant tuberculosis; and Clostridium difficile.
Cubist Pharmaceuticals, Inc. is a 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, Mass. Additional information can be found at Cubist’s web site at www.cubist.com.
Cubist and CUBICIN are registered trademarks of Cubist Pharmaceuticals, Inc.
About IDWeek 2013
IDWeek 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.