Cubist Pharmaceuticals' Antibiotic Programs Featured in 18 Abstracts at 21st ECCMID/27th ICC Joint Congress
LEXINGTON, Mass.--(BUSINESS WIRE)--May 2, 2011 - Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that 18 abstracts featuring research related to its marketed antibiotic and pipeline candidates were accepted for the 2011 joint meeting of the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) and the International Congress of Chemotherapy (ICC). Abstracts feature CUBICIN® (daptomycin for injection), and pipeline candidates CXA-201, which is being developed for the treatment of certain serious Gram-negative bacterial infections, including those caused by multi-drug resistant Pseudomonas aeruginosa, and CB-183,315, a potent, oral, bactericidal lipopeptide, which is being developed for the treatment of Clostridium difficile-associated diarrhea (CDAD). The 21st ECCMID/27th ICC congress will be held from May 7 to 10 in Milan, Italy.
Abstracts accepted for publication or presentation at ECCMID are now posted on the conference website. Following are some abstract highlights related to CUBICIN, CXA-201, and CB-183,315. Abstracts cover topics including (but not limited to) the following:
I. CUBICIN (Abstracts reflect authors' work and may be inconsistent with the approved label for CUBICIN)
US surveillance data for Enterococci and Streptococci
- 14,044 strains were evaluated; gathered from US hospitals from 2002-2010.
- Daptomycin (DAP) demonstrated sustained activity (99.85% susceptibility) against an extensive sampling of clinical isolates of enterococci (including >3,000 vancomycin (VAN)-resistant strains) and streptococci collected from numerous USA medical centers over the last 9 years.
- DAP activity was not adversely influenced by resistance to other antimicrobial classes or VAN among enterococci.
CUBICIN Phase 2 study at 6 and 8mg/kg in patients with Prosthetic Joint Infections
- Consistent with previous top line data Cubist announced in 2010, in which the primary objective to assess the safety and tolerability of CUBICIN at the two doses studied was achieved.
- Although primarily a safety study, clinical and microbiological outcomes were assessed following treatment — with a Test of Cure (TOC) visit 1-2 weeks following the second surgery where a new prosthetic joint was placed. The clinical response rate for CUBICIN at both doses studied was numerically higher than comparator at the TOC visit. This study was not powered for statistical significance.
European surveillance data for Gram-positive organisms including MRSA
- DAP was highly active against a large collection (36,759) of Gram-positive organisms isolated in European hospitals and its activity remained stable across the 7-year period evaluated (2003-2009) using reference methods.
- Decrease in DAP potency has not been observed since EMEA approval and widespread clinical use, and emerging resistance to other compounds did not adversely influence the DAP potency against Gram-positive species.
- MRSA rates (as a % of S. aureus) across Europe varied from a low of 1.3% in Sweden to as high as 61.3% in Portugal and 55.9% in Greece.
CUBICIN use in Outpatient setting in regions outside the US
- Investigators at 237 institutions collected retrospectively anonymized demographic, antibiotic, microbiological and clinical data from medical records using a standardized case report form in the non-interventional European Cubicin Outcomes Registry and Experience (EU-CORESM) in 3 consecutive enrollment periods (Jan 2006-Jun 2010). In the 2nd and 3rd collection periods some non-European sites were progressively included.
- A total of 3621 pts were enrolled in 15 countries, predominantly from Europe.
- According to the authors, daptomycin is an attractive and cost-effective therapeutic option for complicated Gram-positive infections in the outpatient setting.
II. CXA-201 (Currently a Phase 2 program in development to address certain serious infections caused by multi-drug resistant Gram-negative organisms.)
Pharmacokinetic (PK)/pharmacodynamic (PD) target attainment (TA) using different dosing strategies for CXA-201 (CXA 101 in combination with tazobactam (TAZ) against difficult to treat Gram-negative pathogens)
- Monte Carlo (MC) simulations were conducted taking into account differences between subject variability, residual variability and the covariate distribution in the population. PK-PD TA probabilities by MIC and by various treatment regimens were generated for CXA/TAZ.
- Using recent surveillance data, CXA 101/TAZ 1500 mg q8 infused over 60 min is predicted to achieve excellent TA for important pathogens such as Enterobacteriaceae and P. aeruginosa.
III. CB-183,315 (Currently a Phase 2 program in development for the treatment of CDAD — Clostridium difficile-associated diarrhea.)
Activity of a novel lipopeptide against Gram-positive aerobic and anaerobic enteric isolates, including vancomycin-resistant enterococci and C. difficile strains with elevated MICs to metronidazole, vancomycin and fluoroquinolones
- CB-183,315 showed excellent activity against strains of C. difficile which were quinolone-resistant or had elevated MICs to metronidazole or vancomycin.
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.
Cubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on the research, development, and commercialization of pharmaceutical products that address 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 Optimer's drug, DIFICID™, in the U.S. as a treatment of Clostridium difficile infections, assuming approval of DIFICID by the FDA. The Cubist clinical product pipeline currently consists of a Phase 2 program focused on the development of a novel cephalosporin to address certain serious infections caused by multi-drug resistant (MDR) Gram-negative organisms and a Phase 2 program for the treatment of CDAD (Clostridium difficile-associated diarrhea). 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 agents to treat acute pain. 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.
DIFICID is a trademark of Optimer Pharmaceuticals, Inc.
Contact: Cubist Pharmaceuticals, Inc.
Eileen C. McIntyre, (781) 860-8533
Senior Director, Corporate Communications
Tara Murphy, (617) 520-7045
Posted: May 2011