CorMedix Has Meeting With FDA on DefenCath Catheter Lock Solution NDA
April 14 2021 - 9:00AM
CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused
on developing and commercializing therapeutic products for the
prevention and treatment of infectious and inflammatory disease,
announced today that it has met with the US Food and Drug
Administration (FDA) to discuss proposed resolutions for the
deficiencies identified in the Complete Response Letter (CRL) to
CorMedix and the Post-Application Action Letter received by the
third-party manufacturer (CMO) from FDA for the New Drug
Application (NDA) for DefenCath™ (taurolidine/heparin catheter lock
solution). Representatives from both CorMedix and the CMO
participated in the meeting with FDA to ensure that there is
alignment on addressing the Agency’s concerns.
There is now an agreed upon protocol for the manual
extraction study identified in the CRL that FDA is requiring as
confirmation of in-process controls to demonstrate that the labeled
volume can be consistently withdrawn from the vials. As anticipated
previously, CorMedix expects to be able to complete this
requirement in the next several weeks. Addressing FDA’s
concerns regarding the qualification of the filling operation may
necessitate adjustments in the process and generation of additional
data on operating parameters for manufacture of DefenCath. CorMedix
and the CMO are currently evaluating available data to determine if
additional process qualification will be needed with subsequent
validation to address these issues.
The FDA stated that the review timeline would be
determined when the NDA resubmission is received and that it
expected all corrections to facility deficiencies to be complete at
the time of resubmission so that all corrective actions may be
verified during an on-site evaluation in the next review cycle, if
the FDA determines it will do an onsite evaluation. CorMedix and
the CMO continue to work closely to ensure that the identified
deficiencies are resolved prior to resubmission of the DefenCath
NDA.
CorMedix will provide updates on the timeline as
resolution of the deficiencies proceeds.
About CorMedix
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
(QIDP), and the 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. 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 for marketing
authorization; 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. 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.
Investor Contact:
Dan FerryManaging DirectorLifeSci Advisors(617)
430-7576
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