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BERKELEY HEIGHTS, N.J., Oct. 08, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing therapeutic products for life-threatening diseases and conditions, today announced that it has entered into a new commercial supply contract with a top-five mid-sized dialysis operator for the supply of DefenCath® (taurolidine and heparin) to dialysis clinics in the US. This new agreement will provide access to DefenCath for adult patients with kidney failure receiving hemodialysis through a central venous catheter at more than 200 outpatient dialysis clinics located across the United States.
CorMedix received NDA approval of DefenCath under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) on November 15, 2023, and began commercialization of the product in the inpatient setting on April 15, 2024. Outpatient reimbursement of DefenCath from the Center for Medicare & Medicaid Services (CMS) took effect on July 1st, and CorMedix subsequently commenced the shipment of orders to outpatient dialysis facilities in July. CorMedix anticipates shipments for DefenCath under this agreement to begin in the fourth quarter.
“This new agreement, in combination with our existing customer agreements, gives CorMedix the opportunity to make DefenCath available to patients receiving hemodialysis though a CVC at roughly 60% of the outpatient dialysis centers in the US,” says CorMedix CEO, Joseph Todisco. “We are working closely with all of our new customer relationships on the operational steps needed to ensure DefenCath availability in their clinics in the coming months.”
DefenCath® (taurolidine and heparin)
IMPORTANT SAFETY INFORMATION
These highlights do not include all the information needed to use DefenCath safely and effectively. See full prescribing information for DefenCath.
LIMITED POPULATION: DefenCath is indicated to reduce the incidence of catheter-related bloodstream infections (CRBSI) in adult patients with kidney failure receiving chronic hemodialysis (HD) through a central venous catheter (CVC). This drug is indicated for use in a limited and specific population of patients.
DefenCath is contraindicated and has warnings and precautions in patients with:
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Known heparin-induced thrombocytopenia (HIT).
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Known hypersensitivity to any drug products in DefenCath, including taurolidine, heparin or the citrate excipient or pork products.
If exposure to either of the above occurs, discontinue use of DefenCath and institute appropriate supportive measures.
To report any safety concerns including suspected adverse reactions, contact CorMedix Inc. at 1-888-424-6345 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.