CorMedix Inc. Announces Acceptance of Final Post-Marketing Study Data to be Published in the European Journal of Clinical Microbiology and Infectious Diseases
Berkeley Heights, NJ – December 5, 2017 – CorMedix Inc. (NYSE American: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today announced acceptance of the final results of the Company’s observational post-marketing study of Neutrolin® for publication in the top-tier peer-reviewed European Journal of Clinical Microbiology and Infectious Diseases. Neutrolin® is CorMedix’s lead product in Phase 3 development in the U.S. for preventing catheter-related bloodstream infections (CRBSI) in patients undergoing hemodialysis for end stage renal disease. The product is approved for use in the EU under an existing CE Mark.
The article, titled, “Post-Marketing Experience with Neutrolin® (taurolidine, heparin, calcium citrate) Catheter Lock Solution in Hemodialysis Patients,” describes the final results of CorMedix’s Neutrolin® Use Monitoring Program (NUMP). This observational study gathered data from 20 clinical sites in Germany and compared the experience of 201 patients using the product over more than 47,000 catheter days from January 2014 through September 2016 to historical rates of CRBSI and thrombosis. Now accepted, the article is expected to be published by the journal in the coming weeks, links to which will be made available on CorMedix’s website.
Antony Pfaffle, M.D., CorMedix’s Chief Scientific Officer, stated, “The European Journal of Clinical Microbiology and Infectious Diseases is a top-tier, peer-reviewed, authoritative publication in which we are honored to have our final and complete NUMP data published. We believe this additional validation for our data highlighting the positive post-marketing experience observed with Neutrolin® will continue to support the product in Germany and other territories that accept CE Mark, as well as in the U.S. where we are working to complete our first pivotal clinical study in the same indication.”
Bruce Reidenberg, M.D., Adjunct Assistant Professor of Pharmacology at Weill Cornell Medicine and CorMedix Scientific Advisor, stated, “This article describes the results of state-of-the-art care in preventing catheter-related bloodstream infections with favorable historical comparisons from both before and after recent guidelines were instituted.”
CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases. The Company is focused on developing its lead product Neutrolin®, a novel, non-antibiotic antimicrobial solution designed to prevent costly and dangerous bloodstream infections associated with the use of central venous catheters, currently in a Phase 3 clinical trial enrolling patients undergoing chronic hemodialysis. Such infections cost the U.S. healthcare system approximately $6 billion annually and contribute significantly to increased morbidity and mortality. Neutrolin has FDA Fast Track status and is designated as a Qualified Infectious Disease Product, which provides the potential for priority review of a marketing application by FDA and allows for 5 additional years of QIDP market exclusivity in the event of U.S. approval. Neutrolin is already marketed as a CE Marked product in Europe and other territories. In parallel, CorMedix is leveraging its taurolidine technology to develop a pipeline of antimicrobial medical devices, with active programs in surgical sutures and meshes, and topical hydrogels. The company is also working with top-tier researchers to develop taurolidine-based therapies for rare pediatric cancers. For more information, visit: www.cormedix.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including with respect to possible uses of taurolidine, 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 possible inability to capture sufficient CRBSI events in the ongoing Phase 3 clinical trial for Neutrolin® even with the reported changes to that trial; the cost, timing and results of the ongoing and planned Phase 3 trials for Neutrolin® in the U.S. and the resources needed to commence and complete those trials; the risks and uncertainties associated with CorMedix’s ability to manage its limited cash resources and the impact on planned or future research, including for additional uses for taurolidine; obtaining additional financing to support CorMedix’s research and development and clinical activities and operations; preclinical results are not indicative of success in clinical trials and might not be replicated in any subsequent studies or trials; and the ability to retain and hire necessary personnel to staff our operations appropriately. 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.
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