CORMEDIX INC. ANNOUNCES CMS REVISION TO NTAP REIMBURSEMENT OF DEFENCATH
Berkeley Heights, NJ – November 7, 2022 – CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases, today announced that the Center for Medicare & Medicaid Services (CMS) has published in the Federal Register a correction to the Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals New Technology Add on Payment (NTAP) reimbursement of DefenCath, increasing the maximum reimbursement per average hospital visit from $4,387.50 to $14,259.38. The original NTAP calculation by CMS was based upon 3 vials of DefenCath being utilized for catheter lock during 3 sessions of dialysis. The revised NTAP reimbursement is based upon a longer duration of hospital stay in which an estimated average of 9.75 vials of DefenCath would be utilized. The NTAP reimbursement for DefenCath is calculated by CMS as 75% of the expected Wholesale Acquisition Cost (WAC) of the product, and is conditioned upon final approval of the DefenCath New Drug Application by the Food and Drug Administration (FDA) prior to July 1st of 2023. The company also announced today the recent submission of a duplicate NTAP application to CMS, intended to take effect should final approval of the DefenCath NDA by FDA occur after July 1st of 2023.
Joe Todisco, CorMedix CEO stated “We are very pleased that CMS has taken the action to amend the upper limit of reimbursement for DefenCath. As the NTAP is specific to inpatient hospital utilization, adequate financial reimbursement of DefenCath in this setting is essential to incentivizing institutions to proactively address the critical unmet medical need posed by catheter related blood stream infections (CRBSIs) in catheterized hemodialysis patients. The inpatient hospital segment is plagued by not only significant incidence of CRBSIs, but high readmission rates for recurring CRBSIs, both of which lead to adverse patient outcomes, and adverse financial outcomes for hospitals and health systems.”
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 developing its lead product DefenCath™, a novel, antibacterial and antifungal solution designed to prevent costly and life-threatening bloodstream infections associated with the use of central venous catheters in patients undergoing chronic hemodialysis. DefenCath has been designated by FDA as Fast Track and as a Qualified Infectious Disease Product (QIDP), and the original New Drug Application (NDA) received priority review in recognition of its potential to address an unmet medical need. QIDP provides for an additional five years of marketing exclusivity, which will be added to the five years granted to a New Chemical Entity upon approval of the NDA. CorMedix also committed to conducting a clinical study in pediatric patients using a central venous catheter for hemodialysis when the NDA is approved, which will add an additional six months of marketing exclusivity when the study is completed. The Company received a Complete Response Letter (CRL) from FDA stating that the original NDA could not be approved until deficiencies at the contract manufacturing organization (CMO) were satisfactorily resolved. FDA notified the Company in a second CRL that the refiled NDA could not be approved until satisfactory resolution of facility deficiencies identified during a pre-approval inspection at and conveyed to the CMO and during an inspection for an unrelated active pharmaceutical ingredient at and conveyed to the manufacturing facility for the heparin supplier for DefenCath. While the CMO and heparin supplier work to resolve outstanding deficiencies, CorMedix is simultaneously working to transfer the technology to an additional CMO and qualify an additional supplier of heparin. CorMedix also intends to develop DefenCath as a catheter lock solution for use in other patient populations. 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.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects, CorMedix’s plans to submit a resubmission of its NDA application for DefenCath and the timing of such submission; CorMedix’s future financial position, financing plans, future revenues and projected costs should be considered forward-looking. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, including: the ability of the CMO to address the deficiencies identified by the FDA; the ability of the Company’s heparin supplier to address the manufacturing deficiencies identified in the warning letter for non-heparin API; the resources needed to secure approval of the NDA for DefenCath from the FDA; the risks and uncertainties of the relationships with the additional CMO and supplier of heparin; the ability to submit a supplement to CorMedix’s NDA by the end of the first quarter of 2023; the ability to secure final FDA approval prior to July 1, 2023 or obtain CMS approval of a resubmitted NTAP application; the risks and uncertainties associated with CorMedix’s ability to manage its limited cash resources and the impact on current, planned or future research, including the continued development of DefenCath and research for additional uses for taurolidine; obtaining additional financing to support CorMedix’s research and development and clinical activities and operations; preclinical results are not indicative of success in clinical trials and might not be replicated in any subsequent studies or trials; and the ability to retain and hire necessary personnel to staff our operations appropriately. We continue to assess to what extent the uncertainty surrounding the Coronavirus pandemic may impact our business and operations. These and other risks are described in greater detail in CorMedix’s filings with the SEC, 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 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.