CorMedix Inc. Announces Publication of Pharmacoeconomic Study that Highlights the Clinical and Economic Need for Products that Can Prevent Catheter-Related Bloodstream Infections
Data Published in the Journal of Critical Care Supports the Potential of Neutrolin® as a Non-Antibiotic Antimicrobial Solution
Bedminster, NJ – June 13, 2016 – CorMedix Inc. (NYSE MKT: CRMD), a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, announced today publication of a research article highlighting the increased cost and mortality associated with bloodstream infections (“BSI”) following placement of a central venous catheter (“CVC”). CorMedix’s non-antibiotic anti-infective solution Neutrolin® is in Phase 3 clinical development in the U.S. for preventing catheter-related bloodstream infections. Neutrolin demonstrated greater than 96% reduction in infection rate compared to historical benchmarks in an observational study conducted in Europe where Neutrolin is a CE Marked product.
The article titled, “Clinical and Economic Burden of Bloodstream Infections Following Central Venous Catheter Placement in the Intensive Care Unit” will be published in the Journal of Critical Care and is currently available online ahead of print. The study was conducted by DaVita Clinical Research and was presented recently at 21st Annual International Society for Pharmacoeconomics and Outcomes Research Meeting in Washington, DC.
Randy Milby, CorMedix CEO, said, “This research underscores the importance of our work as we pursue the current U.S. Phase 3 clinical trial evaluating the safety and efficacy of Neutrolin for the prevention of catheter-related bloodstream infections and maintenance of catheter patency in CVCs used for vascular access in hemodialysis patients. Currently, there are no pharmacological agents approved in the United States for the prevention of catheter related bloodstream infections. At the same time, data indicates that catheter related bloodstream infections are associated with significant increases in costs of care and risk of death during initial hospitalization.”
The study analyzed patients who had an index hospitalization involving an Intensive Care Unit stay between January 1, 2011 and September 30, 2014 wherein a CVC was placed. Comparisons were made between patients who developed bloodstream infections following CVC insertion (n=522) and those who did not (n=1441). Length of hospital stay, billed costs of the index hospitalization, and total healthcare costs incurred over the 180-day period following discharge were compared, in addition to in-hospital mortality and 30-day readmission rates. The study found that development of BSI (versus not) was associated with longer hospital stay: 15.4 versus 8.6 days, respectively, and greater costs for the index hospitalization, $296,933 versus $188,387, respectively. Development of BSI was associated with a more than 3-fold greater mortality rate, corresponding to an adjusted incidence rate difference of 15.5%.
Full text of the article can be found by visiting the Journal of Critical Care website here:
http://www.jccjournal.org/article/S0883-9441%2816%2930068-5/abstract.
About CorMedix Inc.
CorMedix Inc. is an emerging commercial-stage biopharmaceutical company that initiated a Phase 3 clinical study of a novel anti-infective solution Neutrolin in hemodialysis patients in the United States in December 2015. The Company seeks to in-license, develop and commercialize therapeutic products for the prevention and treatment of infectious and inflammatory diseases. CorMedix's first commercial product in Europe is Neutrolin®, a catheter lock solution for the prevention of catheter related bloodstream infections and maintenance of catheter patency in tunneled, cuffed, central venous catheters used for vascular access in hemodialysis patients, in addition to oncology patients, critical care patients, and patients receiving total parenteral nutrition, IV hydration, and/or IV medications. The FDA has granted Fast Track status to Neutrolin Catheter Lock Solution and also has designated Neutrolin as a Qualified Infectious Disease Product for oncology, hemodialysis, and critical care/intensive care patients, where catheter-related blood stream infections and clotting can be life-threatening. The initial and planned indications aim to address significant needs in catheter-based treatments in the U.S. and the rest of the world. For more information visit: www.cormedix.com.
For Investors & Media:
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Joshua Drumm, Ph.D.: jdrumm@tiberend.com; (212) 375-2664
Janine McCargo: jmccargo@tiberend.com; (646) 604-5150
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or CorMedix's prospects, future financial position, financing plans, future revenues and projected costs should be considered forward-looking. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, including: the results of studies regarding Neutrolin® conducted by us and others; the cost, timing and results of the planned Phase 3 trials for Neutrolin® in the U.S.; obtaining regulatory approvals to conduct clinical trials and to commercialize CorMedix's product candidates, including marketing of Neutrolin in countries other than Europe; obtaining additional financing to support CorMedix's research and development and clinical activities and operations; the risks associated with the launch of Neutrolin in new markets; CorMedix's ability to enter into, execute upon and maintain collaborations with third parties for its development and marketing programs; CorMedix's ability to maintain its listing on the NYSE MKT; the risks and uncertainties associated with CorMedix's ability to manage its limited cash resources; the outcome of clinical trials of CorMedix's product candidates and whether they demonstrate these candidates' safety and effectiveness; CorMedix’s ability to identify and enter into strategic transactions; CorMedix's dependence on its collaborations and its license relationships; achieving milestones under CorMedix's collaborations; CorMedix's dependence on preclinical and clinical investigators, preclinical and clinical research organizations, manufacturers, sales and marketing organizations, and consultants; and protecting the intellectual property developed by or licensed to CorMedix. These and other risks are described in greater detail in CorMedix's filings with the SEC, copies of which are available free of charge at the SEC's website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.
