Cubist to Feature Antibiotic Development Programs at 49th IDSA

LEXINGTON, Mass.--(BUSINESS WIRE)--Oct 20, 2011 - Cubist Pharmaceuticals, Inc. (NASDAQ: CBST), a leading acute care therapeutics company, today provided an overview of selected studies that will be presented at the 49th Annual Infectious Diseases Society of America (IDSA) meeting taking place from October 20th to 23rd, 2011 in Boston. The studies focus on the company's investigational antibiotic, CXA-201, as well as on patterns of first-line treatment for complicated skin and skin structure infections in U.S. hospitals.

“Bacteria are becoming increasingly resistant to our current dwindling inventory of antibiotics, and the importance of appropriately using currently available agents as well as discovering new medicines cannot be underestimated.” said Steven Gilman, Ph.D., Executive Vice President of Research and Development at Cubist Pharmaceuticals. “The presentations at IDSA continue to show the importance of antibiotic development to put in clinicians' hands new drugs to treat Gram-positive and Gram-negative bacteria that cause serious or potentially life-threatening infections.”

“Our primary focus at Cubist is to develop new medicines for serious bacterial infections which are increasingly being caused by drug-resistant superbugs,” said Santosh Vetticaden, M.D., Ph.D., Senior Vice-President, Chief Medical and Development Officer at Cubist Pharmaceuticals. “Our scientists continue to work closely with healthcare providers to better understand and address how current treatment patterns are contributing to the increasingly alarming rates of antibiotic resistance.”

A list of selected presentations can be found on the company's website. Key presentations include:

Intrapulmonary Penetration of CXA-201 and Piperacillin/tazobactam in Healthy Adult Subjects (Abstract 611) Friday, October 21, 2011, 12:15 – 2:15 p.m. EDT, Room: Poster Hall B1.

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 and those in the Enterobacteriaceae family. This Phase 1 study assessed the penetration of CXA-201, compared to the standard-of-care combination of piperacillin/tazobactam, into the epithelial lining fluid (ELF) of the healthy adult lung. CXA-201 penetrated well into the ELF compared to piperacillin/tazobactam, an agent widely used for treatment of lower respiratory infections.

“These new data show that CXA-201 has pharmacologic properties that are well-suited to potentially treat lower respiratory tract infections,” said Dr. Gilman. “We continue to investigate the safety and efficacy profile of this novel antibiotic in a broad Phase 3 development program and hope to offer people with drug-resistant bacterial infections a new treatment option in the future.”

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.

Patterns of Initial Antibiotic Therapy in Hospitalized Patients with Complicated Skin and Skin Structure Infections (cSSSI) in the US: 2007-2010

(Abstract 346) Friday, October 21, 2011, 12:15 – 2:15 p.m. EDT, Room: Poster Hall B1.

Initial antibiotic treatment of complicated skin and skin structure infections (cSSSI) is often based on evidence consisting of presumed source of infection, probable pathogens, patient characteristics and treatment guidelines. This study utilized database information from more than 100 hospitals to paint a real-world picture of cSSSIs treatment patterns. These data have not previously been well documented. The study showed that use of antibiotics that cover Methicillin-Resistant Staphylococcus aureus (MRSA), predominantly vancomycin, continues to increase, especially among patients with community-acquired infections.

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.

Battling superbugs website

“Superbugs” 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 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 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 DIFICID™ 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 announced it expects to initiate Phase 3 trials of a novel antibacterial candidate, CB-183,315, for the treatment of CDAD in the first half of 2012. 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 Cubist'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 to initiate Phase 3 trials 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.

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Contact: INVESTORS:
Cubist Pharmaceuticals, Inc.
Eileen C. McIntyre, 781-860-8533
Senior Director, Investor Relations
eileen.mcintyre@cubist.com
or
MEDIA:
Cubist Pharmaceuticals, Inc.
Francis McLoughlin, 781-860-8777
Director, Corporate Communications
francis.mcloughlin@cubist.com

 

Posted: October 2011

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