Full Press Release Details
CORMEDIX INC. ANNOUNCES REGULATORY, MANUFACTURING AND
Berkeley Heights, NJ - April 26, 2023 - CorMedix
Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and
treatment of life-threatening diseases and conditions, today announced that following its Type A meeting with the FDA, the Company intends
to resubmit its New Drug Application ("NDA") for DefenCath by the middle of May. More specifically:
In addition, CorMedix today announced that following
the submission of a duplicate New Technology Add-On Payment ("NTAP") application in Q4 to the Centers for Medicare & Medicaid
Services ("CMS"), CMS has subsequently issued the Inpatient Prospective Payment System ( IPPS") 2024 proposed
rule that includes a NTAP of up to $17,111 per hospital stay for DefenCath. This NTAP represents reimbursement to inpatient facilities
of 75% of the anticipated WAC price of $1,170 per 3 mL vial, and an average utilization of 19.5 vials per hospital stay. The final IPPS
rule will be published in late summer and we expect this payment amount to be issued in that final rule. This NTAP is conditioned upon
the DefenCath NDA obtaining final FDA approval prior to July 1, 2024.
Joe Todisco, CorMedix CEO stated "I am very
pleased with our Type A meeting discussion with the FDA and the clarity we now have to pursue resubmission of the DefenCath NDA. We will
be working closely with our CMO to ensure compliance readiness should the FDA elect to conduct a pre-approval inspection, and we will
continue our preparations for commercialization. Additionally, I am pleased that CMS has determined again that DefenCath properly meets
the criteria for NTAP inclusion. The utilization of DefenCath can be an important preventative solution for reducing infection risk in
patients undergoing hemodialysis through a central venous catheter, and the Company will continue working aggressively in pursuit of NDA
approval and launch."
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, non-antibiotic antimicrobial 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 at the CMO identified during a pre-approval inspection,
and the satisfactory resolution of facility deficiencies identified at the supplier of heparin API. The CMO and heparin API supplier have
notified CorMedix that they have remediated the respective deficiencies identified by FDA and referenced in the second CRL. 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, and the Company is working with top-tier researchers
to develop taurolidine-based therapies for rare pediatric cancers. 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. All statements,
other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or CorMedix's prospects,
including, but not limited to, statements regarding CorMedix's plans for a resubmission of its DefenCath NDA, the timing of such
resubmission, the manufacturing pathways for resubmission, the classification and timing of NDA resubmission, the results of an FDA prior
approval inspection as part of the NDA review process, and the timing and qualification of an alternative manufacturing site, 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: results of an FDA inspection; the ability of the Company's resubmission to be classified as Class
2 and the timing of review; the ability of an alternate CMO to provide data by the end of the third quarter of 2023 and ability of the
Company to qualify an alternate CMO as an alternate manufacturing site; 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; the ability to secure final FDA approval prior to July 1, 2024 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. 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.