CorMedix Receives Complete Response Letter From FDA for DefenCath™ Catheter Lock Solution
02 March 2021 - 12:30AM
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 the US Food and Drug Administration (FDA)
cannot approve the New Drug Application (NDA) for DefenCath™
(taurolidine/heparin catheter lock solution) in its present form.
FDA noted concerns at the third-party manufacturing facility after
a review of records requested by FDA and provided by the
manufacturing facility. FDA did not specify the issues and CorMedix
intends to work with the manufacturing facility to develop a plan
for resolution when FDA informs the facility of the specific
concerns. When we are informed of the issues, we will schedule an
investor conference call to provide an update on our expected
timeline for resolution. Additionally, FDA is requiring a manual
extraction study to demonstrate that the labeled volume can be
consistently withdrawn from the vials despite an existing
in-process control to demonstrate fill volume within
specifications. CorMedix expects to be able to complete this
requirement expeditiously.
Satisfactory resolution of these issues is required for approval
of the DefenCath NDA by a pre-approval inspection and/or adequate
manufacturing facility responses addressing these concerns. If an
inspection is required, the FDA is currently facing a backlog due
to the pandemic and are actively working to define an approach for
scheduling outstanding inspections once safe travel may resume.
CorMedix will request a meeting with the FDA, which we estimate
will occur by mid-April, to obtain agreement with the Agency on our
proposed plan for resolution of the issues at our third-party
manufacturing facility.
FDA did not request additional clinical data, and did not
identify any deficiencies related to the data submitted on the
efficacy or safety of DefenCath from LOCK-IT-100. In draft labeling
discussed with FDA, the Agency added that the initial approval will
be for the limited population of patients with kidney failure
receiving chronic hemodialysis through a central venous catheter.
This is consistent with our request for approval pursuant to the
Limited Population Pathway for Antibacterial and Antifungal Drugs
(LPAD), which provides for a streamlined clinical development
program involving fewer clinical trials. The LPAD pathway is
intended to encourage the development of safe and effective
products that address unmet medical needs of patients with serious
bacterial and fungal infections.
Khoso Baluch, CEO, stated that “CorMedix intends to work closely
with the FDA and the manufacturing facility to support the
completion of the review of the NDA. We are disappointed that we
will be delayed in bringing DefenCath to an underserved community
with an unmet medical need. We are gratified that FDA did not
identify deficiencies in the safety and efficacy data for DefenCath
and CorMedix will work diligently to bring DefenCath to dialysis
patients who remain at risk of life-threatening catheter-related
blood stream infections.”
DefenCath received designations as Fast Track and Qualified
Infectious Disease Product (QIDP), and the NDA received priority
review. 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 ended the 4th quarter of 2020 with pro forma cash, cash
equivalents and short-term investments of approximately $87.8
million, including capital raised though ATM issuance, which the
company estimates is sufficient to fund operations at least into
second half of 2022.
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, 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.
Investor Contact:
Dan FerryManaging DirectorLifeSci Advisors(617) 430-7576
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