CorMedix seeks QIDP designation from FDA for Neutrolin Catheter Lock Solution

CorMedix Inc. (NYSE MKT: CRMD), a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardiac, renal and infectious disease, has filed a request with the U.S. Food and Drug Administration (FDA) for designation of its lead product candidate, Neutrolin® Catheter Lock Solution, as a qualified infectious disease product (QIDP) pursuant to the Generating Antibiotic Incentives Now (GAIN) title of the Food and Drug Administration Safety and Innovation Act (FDASIA). Neutrolin contains taurolidine, which has been shown to be a potent anti-infective agent that is active against gram positive and gram negative bacteria, and also contains heparin to ensure patency of the catheter. Dr. Douglas Webb, an infectious disease expert and a member of the CorMedix Scientific Advisory Board, noted that "GAIN is intended to encourage development of new antibacterial and antifungal drugs to address serious and life-threatening infections. Neutrolin has shown antimicrobial activity against several of the qualifying pathogens that FDA has designated for GAIN and that are documented to be a serious threat to public health by causing blood-stream infections in hemodialysis patients, including Staphylococcus aureus, Pseudomonas species, and Enterococcus species."

CorMedix is requesting designation of Neutrolin as a QIDP to secure incentives, such as the 5 year extension of marketing exclusivity, for pursuing marketing approval in the U.S. CorMedix intends to conduct clinical trials with Neutrolin^® Catheter Lock Solution in hemodialysis patients and oncology patients, where catheter-related blood stream infections can be life-threatening and infection of catheters with antibiotic resistant bacteria can result in catheter removal.

"We believe Neutrolin is a good candidate for this important designation, especially when development of resistance by microbial pathogens to taurolidine has not been demonstrated," said Randy Milby, CorMedix Chief Executive Officer.

The request for QIDP designation follows the request for Fast Track designation, submitted to FDA in November. Fast Track designation is intended to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. CorMedix believes that Fast Track designation would be beneficial for the rapid development of Neutrolin in the U.S. to expand beyond its current use in Europe.