Tuesday, May 19th @ 12pm Eastern Time
BERKELEY HEIGHTS, N.J., May 06, 2020 (GLOBE NEWSWIRE) -- 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, will host a call with Key Opinion Leaders (KOLs) on the potential of Neutrolin® for addressing antimicrobial resistance and catheter-related bloodstream infections (CRBSIs) on Tuesday, May 19th at 12pm Eastern Time.
The call will feature presentations by KOLs Bruce Polsky, MD, MACP, FIDUSA (NYU Long Island School of Medicine and NYU Winthrop Hospital), Bruce Reidenberg, MD, FAAP, FCP (Weill Cornell Medicine), and Nelson P. Kopyt, DO (Lehigh Valley Health Network) who will discuss antimicrobial resistance, the current CRBSI landscape in patients with hemodialysis catheters, and Neutrolin®'s potential for preventing CRBSIs in these patients. Drs Polsky, Reidenberg, and Kopyt will be available to answer questions at the conclusion of the call.
Neutrolin® is a novel non-antibiotic antimicrobial solution being developed for the prevention of catheter-related bloodstream infections (“CRBSIs”) in patients with end-stage renal disease receiving hemodialysis through a central venous catheter. It has not yet been approved by FDA. The Company has begun NDA submission under rolling review with potential approval in hemodialysis in 2H20.
Neutrolin® has FDA Fast Track status and is designated as a Qualified Infectious Disease Product (QIDP), which provides five years of market exclusivity added to the five years received for approval as a New Chemical Entity (NCE) for a total of 10 years of potential market exclusivity.
Conference Call & Webcast Information
Tuesday, May 19th @ 12pm Eastern Time
Bruce Polsky, MD, MACP, FIDSA is Associate Dean, Faculty and Professor and Chairman of the Department of Medicine at NYU Long Island School of Medicine and NYU Winthrop Hospital in Mineola, LI, New York. Dr. Polsky was previously Chairman of the Department of Medicine (2009-2015), Medical Director of the Clinical Virology Laboratory (1998-2015) and Hospital Epidemiologist (1998-2015) at Mount Sinai St. Luke's and Mount Sinai Roosevelt Hospitals and Professor of Medicine and Pathology at the Icahn School of Medicine at Mount Sinai in New York City. Dr. Polsky is a consultant to CorMedix.
Bruce Reidenberg MD, FAAP, FCP is a consultant to the Pharmaceutical Industry and Adjunct Assistant Professor of Pharmacology at Weill Cornell Medicine and Assistant Clinical Professor of Pediatrics at Mt Sinai's Icahn School of Medicine. He participated in 7 NDAs [Cedax® (antibacterial), Gilenya® (immunosuppressive), Myfortic® (immunosuppressive), Norspan®/Butrans® (opioid analgesic patch), Krystexxa® (injectable recombinant uricase for gout), Tymlos® (injectable PTHrP for osteoporosis), and Trulance® (oral peptide guanyl cyclase agonist for constipation], 3 sNDAs [Cedax® (antibacterial), Lamisil® (antifungal), Neoral® (immunosuppressive)], and more than 10 INDs and is an inventor on 16 issued patents. Dr Reidenberg is also the Medical Director for the Hudson Valley Region of NY State Office for People with Developmental Disabilities and volunteers with the Marathon Medical Team of the NY Road Runner's Club. Dr. Reidenberg is a consultant to CorMedix.
Nelson P. Kopyt, DO is Chief, Division of Nephrology at Lehigh Valley Health Network in Allentown, Pennsylvania and is the Director of Research at the Northeast Clinical Research Center. Dr Kopyt is also a Clinical Professor of Medicine at the University of South Florida Morsani College of Medicine. Dr. Kopyt has more than 20 years of clinical practice experience as well as extensive experience in clinical nephrology research. Dr. Kopyt received his medical training at the Philadelphia College of Osteopathic Medicine and performed his Internal Medicine residency and Nephrology Fellowship at Temple University Health Science Center. Dr Kopyt was an investigator in the LOCK-IT-100 trial evaluating Neutrolin.
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 for the U.S. market. The Company completed a Phase 3 clinical trial of Neutrolin in patients undergoing chronic hemodialysis, which showed a 71% reduction in catheter-related bloodstream infections (CRBSIs) relative to the heparin control arm (p=0.0006) with a good safety profile. 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. FDA has granted rolling submission and review of portions of the new drug application (NDA) and CorMedix has begun submission of the NDA. 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.