Currently, the Company is focused on developing its lead investigational drug product, Defencath™, a novel, antibacterial and antifungal solution designed to prevent catheter-related bloodstream infections (“CRBSIs”) in patients with end-stage renal disease receiving hemodialysis through a central venous catheter.
The Company recently announced that it had submitted the Defencath™ New Drug Application (NDA) to the FDA. The Company requested priority review of the NDA, based on the Fast Track and Qualified Infectious Disease Product Designations granted by FDA to Defencath™. If Priority Review is granted, FDA will have a goal of a 6 month review of the NDA, compared to 10 months for a standard review. In addition to providing the potential for priority review of the NDA, designation as a Qualified Infectious Disease Product (QIDP) allows for five additional years of market exclusivity in the event of U.S. approval. The initial and planned indications aim to address significant needs in catheter-based treatments in the U.S. and the rest of the world.
In Europe, Defencath™ is marketed under the brand name Neutrolin and has CE Mark approval for use in the European Union for hemodialysis using a tunneled central venous catheter and use in oncology patients receiving chemotherapy, hydration and medications via central venous catheters. The CE Marking also covers patients receiving medication and fluids via central venous catheters in intensive or critical care units (cardiac care unit, surgical care unit, neonatal critical care unit, and urgent care centers). Neutrolin also has CE Marking for total parenteral, or IV, nutrition. For more information about Neutrolin and availability in the European Union, visit CorMedix Europe
CorMedix is also researching how it can leverage its taurolidine technology to develop a pipeline of antimicrobial medical devices, with active research 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.
The Company ultimately seeks to in-license, develop, and commercialize therapeutic products for the prevention and treatment of infectious and inflammatory diseases.