BERKELEY HEIGHTS, N.J., Sept. 09, 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 multi-year commercial supply contract with a global healthcare company for the supply of DefenCath® (taurolidine and heparin) to its facilities in the US.
The company, which provides healthcare services to more than 2,000 clinics in the United States, expects to initially target the utilization of DefenCath in up to 4,000 patients nationally, that would be prioritized based upon medical need. 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 in July. CorMedix anticipates shipments for DefenCath under this agreement to begin in the fourth quarter.
“I am very excited that this agreement with one of the premier healthcare services providers in the U.S. will provide access to DefenCath for thousands of adult patients at risk for catheter related bloodstream infections, and it builds upon the progress we have made with smaller customers over the last few months,” says CorMedix CEO, Joseph Todisco. “CorMedix remains committed to our goal of ensuring broad access to this important infection reduction mechanism.”
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:
- Known heparin-induced thrombocytopenia (HIT).
- 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.
Please see the full Prescribing Information.
About CorMedix
CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. The Company is focused on commercializing its lead product DefenCath®, which was approved by the FDA on November 15, 2023. CorMedix commercially launched DefenCath in inpatient settings in April 2024 and began outpatient commercialization on July 1st following the effectiveness of outpatient reimbursement from CMS. CorMedix also intends to develop DefenCath as a catheter lock solution for use in other patient populations. For more information visit: www.cormedix.com.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are subject to risks and uncertainties. Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “will,” “plan,” “project,” “seek,” “should,” “target,” “will,” “would,” and similar expressions or variations intended to identify forward-looking statements. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects should be considered forward-looking statements. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, and readers are directed to the Risk Factors identified in CorMedix’s filings with the SEC, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q, 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 such forward-looking statements speak only as of the date of this press release. 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.
Investor Contact:
Dan Ferry
Managing Director
LifeSci Advisors
daniel@lifesciadvisors.com
(617) 430-7576
