New Treatment Options for Carbapenem-Resistant Enterobacteriaceae (CRE) Infection Needed, According to Study by The Medicines Company

18 Sep 2015

Researchers at The Medicines Company presented data from a multi-national cohort that demonstrates the mortality and morbidity, and poor outcomes, associated with current therapies in patients with infections due to carbapenem-resistant Enterobacteriaceae (CRE). The data from this analysis has guided the design of the Company’s ongoing clinical studies of its Phase 3 compound, CARBAVANCE® (meropenem/RPX7009) and was presented at the Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC) and the International Congress of Chemotherapy and Infection (ICC) joint meeting in San Diego, CA.

“Clinicians face limited antibiotic choices in treating CRE and the outcomes in these patients are very poor,” said Jeff Loutit, MBChB, Vice President and Chief Medical Officer in the Infectious Disease Global Innovation Group at The Medicines Company. “The high mortality rate and poor clinical and microbiological cure rates illustrate the extremely poor efficacy of currently available therapies in this highly comorbid patient population.”

According to the U.S. Centers for Disease Control and Prevention (CDC), CRE is one of the three most urgent antimicrobial resistance threat pathogens, making this gram-negative bacteria an immediate public health threat that requires urgent and aggressive action1. CRE infections are spreading in healthcare facilities throughout the United States and the world1. CRE bacteria have become resistant to all or nearly all first-line antibiotics available today, including carbapenems, which are often used due to resistance to other antimicrobials, particularly in the treatment of serious infections1.

The analysis was conducted in patients with severe infections due to CRE to assess outcomes with current treatment options (“best available therapy”) and to guide the design of the Company’s ongoing clinical studies of CARBAVANCE® (meropenem/RPX7009). “Our analysis has shown that patients with CRE infections are very ill, with multiple comorbid conditions that often exclude them from clinical trials,” said Elizabeth Alexander, MD, Director of Clinical Development at The Medicines Company and lead investigator on the study. “This analysis has informed us on the planning and execution of our Phase 3 study of CARBAVANCE® in this patient population.”

The study titled, Designing Clinical Trials for New Agents in CRE Infection: What is “Best Available Therapy” in CRE and How Well Does it Work?, reviewed the treatment of 257 adult patients at 22 major medical centers in the U.S., the U.K., Italy and Greece over a six-month period. Patients with complicated urinary tract infection (cUTI), acute pyelonephritis (AP), hospital acquired bacterial pneumonia (HABP), ventilator associated bacterial pneumonia (VABP), or bacteremia due to CRE pathogens were included in the analysis. There was a high morbidity and mortality rate among the patients, with a 28-day mortality of 28% that was highest in patients with hospital-acquired (35%) and ventilator-associated (33%) bacterial pneumonia, and lowest among in patients with cUTI/AP (18%). Only 57% of patients achieved a clinical cure and just over half (52%) achieved microbiological eradication.

The U.S. Centers for Disease Control (CDC) has listed CRE as an urgent public health threat. An estimated 140,000 healthcare-associated Enterobacteriaceae infections occur in the United States each year and about 9,300 are caused by CRE. However, even for critical pathogens like CRE, there is not a complete picture of the domestic incidence, prevalence, mortality, and cost of resistance1.

“The Medicines Company is committed to developing and commercializing solutions to address a variety of serious and urgent antimicrobial resistance threats, such as CRE,” said Michael Dudley, PharmD, Senior VP and Head, Health Science R&D, and Co-Leader of the Infectious Diseases Global Innovation Group at The Medicines Company. “This analysis points to the urgent need for more treatment options and study of new agents in patients with CRE.”

About CARBAVANCE® (meropenem/RPX7009)

CARBAVANCE®, an investigational agent not approved for commercial use in any market, is a combination of meropenem and RPX7009 administered as a fixed combination by IV infusion and is being developed to treat serious gram-negative infections, such as cUTIs, including those infections caused by bacteria resistant to currently available carbapenems.

CARBAVANCE® was designed to address resistant gram-negative bacteria that produce beta-lactamase enzymes that have spread in the US and Europe, including strains producing the Klebsiella pneumoniae carbapenemase (KPC) enzyme. KPC-producing bacteria are the predominant form of carbapenem-resistant Enterobacteriaceae (CRE) in the US and are classified by the US Centers for Disease Control and Prevention (CDC) to be an urgent microbial resistance threat. CARBAVANCE® has been designated as a qualified infectious disease product (QIDP) by the US FDA.

About The Medicines Company

The Medicines Company's purpose is to save lives, alleviate suffering and contribute to the economics of healthcare by focusing on 3000 leading acute/intensive care hospitals worldwide. Its vision is to be a leading provider of solutions in three areas: serious infectious disease care, acute cardiovascular care and surgery and perioperative care. The company operates in the Americas, Europe and the Middle East, and Asia Pacific regions with global centers today in Parsippany, NJ, USA and Zurich, Switzerland.

Forward-Looking Statements

Statements contained in this press release about The Medicines Company that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes," "anticipates," "expects," “hopes,” and “potential” and similar expressions, are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include whether our product candidates, including CARBAVANCE ®, will advance in the clinical trials process on a timely basis or at all, whether physicians, patients and other key decision makers will accept clinical trial results, whether the Company will make regulatory submissions for its product candidates on a timely basis or at all, whether its regulatory submissions will receive approvals from regulatory agencies on a timely basis or at all, the Company’s ability to successfully compete with potential competitors which may discover, develop or commercialize competing products more successfully than we do, and such other factors as are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company's Quarterly Report on Form 10-Q filed with the SEC on August 7, 2015, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.

1 CDC. Antibiotic Resistance Threats in the United States, 2013. Accessed Aug. 27, 2015.


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