Health & Fitness
Health and Fitness
Health and Fitness
Fri, September 16, 2011
Thu, September 15, 2011 Cubist Antibiotic Programs Featured in 49 Presentations at 51st ICAAC
LEXINGTON, Mass.--([ BUSINESS WIRE ])--[ Cubist Pharmaceuticals, Inc. ] (NASDAQ: CBST), a leading acute care therapeutics company, today provided an overview of selected studies that will be presented at the 2011 Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) taking place from September 17th to 20th in Chicago. The studies focus on the companya™s marketed antibiotic CUBICIN® (daptomycin for injection) and clinical antibiotic programs, CXA-201 and CB-183,315.
"The close to fifty presentations on Cubista™s approved antibiotic and investigational agents demonstrate our commitment to finding new cures for serious or potentially life-threatening infections."
aBacteria are becoming increasingly resistant to our current repertoire of antibiotics, and the importance of appropriately using currently available agents as well as discovering new medicines cannot be underestimated.a said Steven Gilman, Ph.D., Executive Vice President of Research and Development at Cubist Pharmaceuticals. aThe close to fifty presentations on Cubista™s approved antibiotic and investigational agents demonstrate our commitment to finding new cures for serious or potentially life-threatening infections.a
A list of selected presentations can be found on the companya™s [ website ]. Key presentations on CXA-201 and CB-183,315 include the following:
Potency of CXA-101/tazobactam (CXA-201) for Pathogens from ICU and Non-ICU Correlated to Probability of Pharmacokinetic/Pharmacodynamic Target Attainment (Presentation A-1689) Saturday, September 17, 2011, 8:30 - 11:00 a.m. CDT, Room W196c.
CXA-201, a novel cephalosporin in combination with tazobactam, is in development for the treatment of certain serious infections caused by multi-drug resistant (MDR) Gram-negative organisms, particularly Pseudomonas aeruginosa. CXA-201 is in Phase 3 trials for complicated urinary tract infections, and Cubist expects to initiate Phase 3 trials with CXA-201 in complicated intra-abdominal infections by the end of 2011. In addition, Phase 3 trials of CXA-201 in hospital acquired (nosocomial) pneumonia are expected to begin in 2012.
Efficacy and Safety of the Lipopeptide CB-183,315 for the Treatment of Clostridium difficile Infection (Presentation K-205a) Saturday, September 17, 2011, 11:30 a.m. - 1:30 p.m. CDT, Hall F1. This is a late breaker poster presentation.
This study compared the efficacy and safety of CB-183,315, a novel investigational antibiotic, against oral vancomycin, a standard of care medicine for Clostridium difficile-associated diarrhea (CDAD). C. difficile infections can lead to severe diarrhea, sepsis and even death. Cubist has completed Phase 2 trials of CB-183,315 for the treatment of CDAD and plans to make a go/no go decision of whether to move CB-183,315 into Phase 3 trials in the third quarter of 2011.
More than 80 abstracts mention or focus on daptomycin a" 43 are highlighted in Cubista™s selected abstracts [ document ].
Cubist-ICAAC Award
Beginning at this yeara™s ICAAC meeting, Cubist has the special privilege of sponsoring the Cubist-ICAAC Award, which rewards outstanding accomplishment in antimicrobial chemotherapy, development of new agents, investigation of antimicrobial action or resistance to antimicrobial agents, and/or the pharmacology, toxicology or clinical use of those agents. This yeara™s honoree is John G. Bartlett, MD, School of Medicine, Johns Hopkins University, and Founding Director, Center for Civilian Biodefense Strategies. Dr. Bartlett is a world renowned expert in infectious diseases. The Award will be presented as part of the Cubist-ICAAC Award Lecture, which will be held during the meeting on Sept. 19th from 4:30 to 5:30 p.m. in Room W375c.
Cubist launches new website focusing on antibiotic-resistant bacteria
aSuperbugsa or antibiotic-resistant bacteria pose an ever increasing threat to global public health. More information, including perspective from academic and company doctors and scientists, can be found at [ www.battlingsuperbugs.com ]
About CUBICIN
CUBICIN® (daptomycin for injection) is approved in the U.S. and many other non-US markets as therapy for Staphylococcus aureus bloodstream infections (bacteremia), including right-sided endocarditis, caused by methicillin-resistant S. aureus (MRSA) and methicillin-susceptible S. aureus (MSSA), and complicated skin infections caused by certain Gram-positive bacteria, including MRSA. CUBICIN is not indicated for the treatment of pneumonia. Most adverse events reported in clinical trials were mild to moderate in intensity. The most common 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 Infection-causing bacteria
Bacteria are categorized in two main classes, Gram-positive and Gram-negative. This classification is based on the structure of the bacterial cell and has implications as it relates to antibiotics. Both Gram-positive and Gram-negative bacteria cause infections. Resistance to commonly-used antibiotics is becoming increasingly prevalent in both Gram-positive and Gram-negative bacteria. Gram-positive bacteria, such as Staphylococcus aureus, generally have a thick outer cell wall and a single cell membrane, whereas Gram-negative bacteria, like Pseudomonas aeruginosa, have an outer cell membrane and a thinner cell wall. Infection-causing Gram-positive bacteria include S. aureus and Clostridium difficile. Diseases caused by these Gram-positive bacteria include infections caused by Methicillin-Resistant S. aureus, commonly referred to as MRSA, and C. difficile-associated diarrhea (CDAD). Examples of infective Gram-negative bacteria include Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, and Acinetobacter baumannii. The diseases caused by Gram-negative bacteria include peritonitis (a type of abdominal infections), septicemia (blood infection), pneumonia, neonatal (newborn) meningitis, urinary tract infections, intra-abdominal infections and burn and wound infections.
About Pseudomonas aeruginosa
P. aeruginosa is one of the most prevalent Gram-negative bacteria responsible for hospital-acquired infections (also known as nosocomial infections). Nosocomial infections are becoming increasingly common in intensive care units (ICU) and data from the National Nosocomial Infections Surveillance of ICUs in the United States shows that P. aeruginosa is the most frequently isolated Gram-negative cause. Pseudomonal infections in the hospital causing pneumonia and urinary tract infections have almost doubled between 1975 and 2003. Similar increases in Pseudomonal infections were observed in Europe SENTRY Antimicrobial Surveillance Program, between 1997 and 2002. Pseudomonal infections can involve any part of the human body, but among the most common are lung urinary tract, bloodstream, wound/burn, and intra-abdominal infections. Resistance to current treatment regimens for such infections is growing, with the increasing appearance of P. aeruginosa strains expressing multi-drug resistance against commonly used anti-pseudomonal antibiotics.
About CDAD
CDAD is a disease caused by an overgrowth of, and toxin production by C. difficile, a Gram-positive bacterium naturally found in the lower gastrointestinal tract. This overgrowth is caused by the use of antibiotics for the treatment of common community and hospital acquired infections. Many antibiotics cure the underlying infection but, as a consequence, disrupt the natural balance of intestinal bacteria which C. difficile to overgrow. The overgrown C. difficile bacteria produce enterotoxin and cytotoxin, two proteins that can lead to potentially life-threatening severe diarrhea and sepsis (blood infection). CDAD rates and severity are increasing, due in part to the spread of a new strain with increased virulence and greater resistance to fluoroquinolones, a standard of care treatment. According to an article in the October 2008 issue of the New England Journal of Medicine, during the mid- and late-1990s, the reported incidence of C. difficile infections in acute care hospitals in the United States remained stable at 30 to 40 cases per 100,000. However in 2001, this number rose to almost 50, with subsequent increases to the point that the number of cases that were reported in 2005 (84 per 100,000) was nearly three times the 1996 rate (31 per 100,000).
About Cubist
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. In the U.S., Cubist markets CUBICIN® (daptomycin for injection), the first antibiotic in a class of anti-infectives called lipopeptides, and has an agreement with Optimer Pharmaceuticals, Inc. to co-promote DIFICIDa" in the U.S. as a treatment of CDAD (Clostridium difficile-associated diarrhea) in adults. The current Cubist clinical development pipeline includes CXA-201, a novel cephalosporin in combination with tazobactam in development for the treatment of certain serious infections caused by multi-drug resistant (MDR) Gram-negative organisms. CXA-201 is in Phase 3 trials for complicated urinary tract infections (cUTI), and Cubist expects to initiate Phase 3 trials with CXA-201 in complicated intra-abdominal infections (cIAI) by the end of 2011. In addition, Phase 3 trials of CXA-201 in hospital acquired (nosocomial) pneumonia are expected to begin in 2012. Cubist has completed Phase 2 trials of a novel antibacterial candidate, CB-183,315, for the treatment of CDAD and plans to make a go/no go decision of whether to move CB-183,315 into Phase 3 trials in the third quarter of 2011. Cubist also is working on several pre-clinical programs being developed to address areas of significant medical needs. These include therapies to treat various serious bacterial infections and acute pain. Cubist is headquartered in Lexington, Mass. Additional information can be found at Cubista™s web site at [ www.cubist.com ].
Cubist Safe Harbor Statement
This press release contains forward-looking statements regarding plans to continue to advance CXA-201 in Phase 3 clinical trials and plans to make a decision about whether to initiate a Phase 3 trial of CB-183,315 in CDAD There are many factors that could cause actual results to differ materially from those in these forward-looking statements. These factors include the following: CXA-201 and CB-183.315 may not show sufficient therapeutic effect or an acceptable safety profile in Phase 3 clinical trials; CXA-201 and CB-183.315 may not act in the way expected based on prior clinical and pre-clinical trials; clinical trials of CXA-201 and CB-183.315 may not be successful or initiated or conducted in a timely manner and the timing of initiation and conduct of subsequent trials is dependent on our ability to successfully work with regulatory authorities, including the FDA on the design of the trials, among other things; we plan to rely, to a significant extent, on third party clinical research organizations, or CROs, to help us conduct clinical trials so the success and timing of the trials is dependent our ability to work with such CROs and their performance; the commercial market for the intended use of CXA-201 and CB-183,315 may not be as large as Cubist anticipates; if approved, CXA-201 and CB-183,315 will compete with products currently on the market and may also compete with products currently in development which may have superior efficacy and/or safety profiles as CXA-201 and CB-183,315 or have other attributes that make it difficult for CXA-201 and CB-183,315 to succeed commercially in such markets; technical difficulties or excessive costs relating to the manufacture or supply of CXA-201 and CB-183,315; we plan to rely, to a significant extent, on third party contract manufacturers and suppliers to manufacture and supply CXA-201 and CB-183,315 on our behalf so our ability to obtain adequate supplies of CXA-201 and CB-183,315 is dependent on our ability to work with such third parties and on their performance; we, and Astellas Pharma Inc., from which we have licensed our rights to CXA-101 one of the active ingredients in CXA-201, may not be able to maintain and enforce such intellectual property, and we may not be able to maintain and enforce other intellectual property protecting CXA-201 or the intellectual property protecting CB-183,315; and we may encounter other unanticipated or unexpected risks with respect to the development or manufacture of CXA-201 and CB-183,315. Drug development involves a high degree of risk. Success in pre-clinical trials or early stage clinical trials does not mean that later stage trials will be successful. Additional factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statements are contained in Cubist's recent periodic filings with the Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in such filings. These statements speak only as of the date of this release, and Cubist undertakes no obligation to update or revise these statements, except as may be required by law.
Cubist and CUBICIN are registered trademarks of Cubist Pharmaceuticals, Inc.
DIFICID is a trademark of Optimer Pharmaceuticals, Inc.
