CorMedix Inc. Announces New Commercial Agreement
Rhea-AI Summary
CorMedix Inc. (Nasdaq: CRMD) has announced a new commercial supply contract with a top-tier mid-sized dialysis operator in the US for DefenCath® (taurolidine and heparin). This agreement will provide DefenCath access to adult kidney failure patients receiving hemodialysis through central venous catheters at over 250 outpatient dialysis clinics across the country.
CorMedix received NDA approval for DefenCath on November 15, 2023, and began commercialization in the inpatient setting on April 15, 2024. Outpatient reimbursement from CMS took effect on July 1st, with shipments to outpatient facilities commencing in July. The company anticipates shipments under this new agreement to begin in early Q4 2024.
Positive
- New commercial supply contract with a top-tier mid-sized dialysis operator
- Access to over 250 outpatient dialysis clinics across the US
- Outpatient reimbursement from CMS effective July 1st, 2024
- Shipments to outpatient facilities commenced in July 2024
- Anticipated shipments under new agreement to begin in early Q4 2024
Negative
- None.
News Market Reaction 1 Alert
On the day this news was published, CRMD declined 3.24%, reflecting a moderate negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
BERKELEY HEIGHTS, N.J., Sept. 19, 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-tier 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 250 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 beginning of the fourth quarter.
“We’ve made great progress over the last few months in terms of operationalizing existing customers as well as signing new agreements with top-tier dialysis providers in the US,” says CorMedix CEO, Joseph Todisco. “I am excited by the trajectory we are seeing for product utilization with early adopters and optimistic about the potential for utilization under these new relationships.”
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 in outpatient settings in July 2024. 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
FAQ
What is the new commercial agreement announced by CorMedix (CRMD)?
When did CorMedix (CRMD) receive NDA approval for DefenCath?
When did CorMedix (CRMD) begin commercialization of DefenCath in the inpatient setting?
When did outpatient reimbursement for DefenCath from CMS take effect for CorMedix (CRMD)?
