CorMedix to Present at the 1st Gulf Congress of Clinical Microbiology and Infectious Diseases
Bedminster, NJ – April X, 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 that a clinical abstract, titled “A Novel Taurolidine Containing Catheter Lock Solution (CLS) Without Reported Antimicrobial Resistance, Reduces the Rates of Infection And Thrombosis in Hemodialysis Patients Enrolled In a Post-Approval Surveillance Study” highlighting key data from the Company’s landmark post-approval surveillance study will be presented as a poster during the 1st Gulf Congress of Clinical Microbiology and Infectious Diseases, to be held May 4-7 2016 in Dubai, United Arab Emirates.
“Catheter related bloodstream infections are a world-wide problem, as evidenced in the global medical community’s interest in our novel catheter lock solution,” said Randy Milby, Chief Executive Officer, CorMedix. “The healthcare community recognizes the need to protect vulnerable patients who are already on catheters from the additional risks of bloodstream infections. We’re excited to share some of the results from real world use of Neutrolin in the clinical setting.”
The Neutrolin® Usage Monitoring Program (NUMP) examined the use of CorMedix’s commercialized product in Europe. Neutrolin is an anti-infective solution for the prevention of catheter-related blood infections and thrombosis, which are the major complications observed in patients undergoing hemodialysis. The results to be published compare the reduced rates of these catheter-related complications with routine use of Neutrolin as a novel catheter lock solution versus historical benchmark rates.
About Neutrolin
Neutrolin is a novel formulation of taurolidine, citrate and heparin 1000 units/ml that provides a combination preventative solution that decreases the threat of infection and thrombosis. Neutrolin keeps catheters operating safely and efficiently by optimizing catheter blood flow, while minimizing catheter-related infection rates for oncology, hemodialysis, and intensive care patients. To date, Neutrolin has no reported human resistance. Neutrolin has CE mark approval for use in the European Union and CorMedix initiated a Phase 3 clinical program in the United States in December 2015. The U.S. Food and Drug Administration (FDA) has designated Neutrolin as a Qualified Infectious Disease Product (QIDP), which provides an additional five years of market exclusivity in addition to the five years granted for a New Chemical Entity.
Of note is the recent release of the end stage renal disease Prospective Payment System final rule from the Centers for Medicare & Medicaid Services (CMS), as it proposed an approach to pay for new drugs that suggests the agency is open to considering alternative reimbursement schemes for products that have been designated as priorities by the FDA under the GAIN Act or the QIDP Act. CorMedix will be working with CMS to discuss Neutrolin specifically, and hopes to position it favorably in light of its potential to reduce infections and lower healthcare system costs.
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:
CorMedix
Maureen McEnroe, CFA: Maureen@machealthcare.com; (914) 588-1873
Tiberend Strategic Advisors, Inc.
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 additional financing to support CorMedix's research and development and clinical activities and operations; obtaining regulatory approvals to conduct clinical trials and to commercialize CorMedix's product candidates, including marketing of Neutrolin in countries other than Europe; 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.
