Full Press Release Details
INC. Announces fda acceptance for filing and priority review of new drug application for defencath
sets PDUFA goal date of February 28, 2021
the first antibacterial and antifungal catheter lock solution in the US to prevent catheter related infections in hemodialysis
NJ - August 31, 2020 - CorMedix Inc. (NYSE American: CRMD), a biopharmaceutical company focused on developing
and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today announced
that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's submitted New Drug Application (NDA)
for Defencath , its product candidate to be used as a catheter lock solution in hemodialysis patients for the
prevention of catheter related blood stream infections (CRBSI). The FDA had previously granted a rolling submission and review,
which the Company completed at the end of June. The FDA also granted priority review and set a Prescription Drug User Fee Act
(PDUFA) date of February 28, 2021 for the completion of its review for approval of the NDA. The Agency noted that it is planning
to hold an advisory committee meeting to discuss the application and that it had not identified any potential review issues at
Khoso Baluch, CorMedix CEO commented,
"The NDA acceptance is truly a momentous achievement for CorMedix, the internal and external teams involved with the submission,
and most importantly, the hemodialysis patient community. We are proud of our team for exceptional effort to get us to this point
and look forward to bringing Defencath to patients to prevent the serious complications and costs associated with CRBSI in this
significant patient population."
CorMedix Executive Vice President and General Counsel, further added, "Having been actively involved with the Defencath program
and regulatory journey for the past several years, it is very rewarding to have the FDA's acceptance of our first NDA as
an essential step toward our goal of offering Defencath in the U.S. as the first antimicrobial catheter lock solution for the prevention
of life-threatening CRBSI in hemodialysis patients. We are very appreciative that the Agency granted priority review and despite
the ongoing pandemic, we look forward to continuing to work together expeditiously to complete the review of the Defencath NDA
to address an unmet medical need."
priority review to applications for potential therapies that, if approved, would be significant improvements in the safety or effectiveness
of the treatment, diagnosis or prevention of serious conditions when compared to standard applications. CorMedix included in the
Defencath NDA submission positive results from the 795 patient LOCK-IT-100 clinical trial, which demonstrated a good safety profile
and a highly statistically significant reduction of 71% (p=0.0006) in CRBSI in patients undergoing hemodialysis compared to heparin,
the current standard of care. Defencath had been granted Fast Track and Qualified Infectious Disease Product (QIDP) designations
by the FDA, which provided eligibility to request priority review of the NDA.
CorMedix Inc. is a biopharmaceutical company
focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory
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, which provides 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 intends to develop Defencath as a catheter lock solution for
use in oncology and total parenteral nutrition patients. It is leveraging its taurolidine technology to develop a pipeline of
antimicrobial medical devices, with programs in surgical sutures and meshes, and topical hydrogels. The Company is also
working with top-tier researchers to develop taurolidine-based therapies for rare pediatric cancers. Neutrolin
is CE Marked and marketed in Europe and other territories as a medical device. 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 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, 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 results of our discussions with the FDA regarding the Defencath development path, including
whether a second Phase 3 clinical trial will be required for approval of Defencath's marketing approval; the resources needed
to secure approval of the new drug application for Defencath from the FDA; 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/Neutrolin 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. At this time, we are unable to assess whether, and 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.