SUNNYVALE, Calif., June 19, 2014 /PRNewswire/ -- Cepheid (Nasdaq: CPHD) today announced a new collaboration with AstraZeneca, Cubist Pharmaceuticals, Inc., and GSK intended to promote transformational change in infectious disease therapy by developing a rapid diagnostic test that can target multi-drug resistant pathogens and support the appropriate use of antibiotics. Targeting bacterial infections with the right treatment will slow the development of resistance that has led to a crisis in treating infections.
Xpert® Carba-R is a rapid test under development for use with rectal swab samples to identify the presence of potentially life threatening bacteria. Specifically, the consortium is working to extend the number of body sample types from rectal swabs to other body samples such as respiratory samples from patients with pneumonia. Xpert Carba-R is commercially available outside the US, and is targeted for commercial release in the US in 2015, subject to regulatory approval.
According to a 2013 report by the US Centers for Disease Control and Prevention1 (CDC), up to 50% of all antimicrobial agents that are prescribed are unnecessary or are not likely to be effective as prescribed. This has contributed to the emergence and spread of multiple species of bacteria that are resistant to many, and in some cases all, of the antimicrobial agents that are available for therapy. In the United States alone, more than 2 million people each year acquire a serious bacterial infection that is resistant to one or more of the antimicrobial agents intended to treat it.
"There is clearly a need to identify patients with multidrug-resistant infections more rapidly and provide them with more potent antimicrobial agents, especially those that are active against multidrug resistant organisms," said Dr. Fred Tenover, Cepheid's Vice President for Scientific Affairs and former Director of CDC's Office of Antimicrobial Resistance. "Once available, our Xpert Carba-R test could prove to be a valuable tool as the fight against multidrug resistant infections intensifies. Cepheid is very pleased to be working with these distinguished pharmaceutical partners to meet their diagnostic needs, reduce the complexity of clinical trials, and accelerate the approval of these much needed anti-infective compounds."
Manos Perros, Vice-President and Head of AstraZeneca Infection Innovative Medicines added, "Developing rapid molecular diagnostics will enable physicians to treat patients suffering from bacterial infections with a new generation of safe and well tolerated antibiotics that will target drug-resistant pathogens in an effective way that is not possible with today's drugs. The work of this consortium will generate diagnostics which we can use to match the right drug to the patient, help develop our emerging pipeline of pathogen-targeted antibacterials, and step up the fight against the threat of antibacterial resistance."
"Antibiotic resistance is a serious health crisis that demands immediate attention. We need both to significantly improve our management of current antibiotics while also investing aggressively in new antibiotics to address these emerging threats," said Lorianne K. Masuoka, M.D., Senior Vice President, Clinical Development and Medical Affairs, and Chief Medical Officer of Cubist. "A comprehensive and targeted approach combining rapid diagnostics with antibiotics will advance efforts to treat the right patients at the right time at the right dose and duration."
Concluding, Linda A. F. Miller, Ph.D., Director of Diagnostics and Clinical Microbiology for GSK Antibacterial R&D, stated, "Bacteria have responded to antibacterial drugs by developing resistance. To make sure we do not go back to the pre-antibiotic era where simple infections were very dangerous and many current hospital procedures and treatments would be impossible, we need to more effectively use the antimicrobials we have and we need to develop new medicines. Accurate, rapid, easy to use diagnostic tests that can identify infecting pathogens directly from a patient sample will alter the way we treat bacterial infections by allowing us to enhance the efficiency of clinical trials and provide physicians with test results prior to making critical treatment decisions. GSK enthusiastically supports the steps we are taking together with Cepheid, AZ and Cubist to help move us toward a new era in the development and use of antibacterial medicines."
Based in Sunnyvale, Calif., Cepheid is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. For more information, visit http://www.cepheid.com.
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com
Cubist Pharmaceuticals, Inc. is a global 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, Massachusetts, with a central international office located in Zurich, Switzerland. Additional information can be found at Cubist's web site at www.cubist.com.
One of the world's leading research-based pharmaceutical and healthcare companies committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit http://www.gsk.com/.
- Antibiotic Resistance Threats in the United States 2013, US Department of Health and Human Services, Centers for Disease Control and Prevention.
This press release contains forward-looking statements that are not purely historical regarding Cepheid's or its management's intentions, beliefs, expectations and strategies for the future, including those relating to the timing and achievement of product regulatory approval and commercial release, the performance, speed and accuracy of our products, including relative to competing products, the breadth and speed of test menu expansion, the results of clinical trials, and future medical practice dynamics, including the utilization of our tests in a clinical environment. Because such statements deal with future events, they are subject to various risks and uncertainties, and actual results could differ materially from the Company's current expectations. Factors that could cause actual results to differ materially include risks and uncertainties such as those relating to: test performance in the field; utilization of our tests by clinicians; our ability to successfully develop new products; the completion of clinical trials for new products successfully and in a timely manner; uncertainties related to the United States FDA, European and other regulatory processes; the Company's ability to successfully introduce and sell products in clinical markets; the Company's research and development budget; unforeseen supply, development and manufacturing problems; the potential need for additional intellectual property licenses for tests and other products and the terms of such licenses; the impact of competitive products and pricing; the Company's ability to manage geographically-dispersed operations; and underlying regulatory, political and market conditions worldwide. Readers should also refer to the section entitled "Risk Factors" in Cepheid's Annual Report on Form 10-K, its most recent Quarterly Report on Form 10-Q, and its other reports filed with the Securities and Exchange Commission.
All forward-looking statements and reasons why results might differ included in this release are made as of the date of this press release, based on information currently available to Cepheid, and Cepheid assumes no obligation to update any such forward-looking statement or reasons why results might differ.