CorMedix Inc. Announces Resubmission of New Drug Application for DefenCath
May 16 2023 - 7:00AM
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 the New Drug Application for
DefenCath was resubmitted to the U.S. Food and Drug Administration,
and the submission has been acknowledged as received for
processing.
Joe Todisco, CorMedix CEO, commented, “We are
excited to share that yesterday after the conclusion of our
earnings call, the DefenCath NDA was resubmitted to FDA. The
resubmission reflects the hard work of the CorMedix regulatory and
technical teams and our strategic partners. We look forward to
providing additional updates as we progress toward potential
approval in 2023 and aim to deliver on our commitment to reducing
the risk of infections in patients receiving hemodialysis via
central venous catheters.”
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 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 second Complete Response Letter from the FDA last August
related to deficiencies at both its primary contract manufacturer
and its supplier of heparin API. The Company conducted a Type A
meeting with FDA in April of 2023 and received guidance to support
resubmission of the NDA for DefenCath. 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 the
ability of the Company’s DefenCath NDA resubmission to be
classified as Class 2 and the timing of review, CorMedix’s future
financial position, financing plans, future revenues, projected
costs and the sufficiency of our cash and short-term investments to
fund our operations 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 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; the risks and
uncertainties associated with CorMedix’s ability to manage its
limited cash resources and the impact on current, planned or future
research; 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.
Investor Contact:Dan FerryManaging
DirectorLifeSci Advisors(617) 430-7576
CorMedix (NASDAQ:CRMD)
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