CorMedix Inc. Announces Issuance of U.S. Patent Covering Lead Product Defencath
August 30 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 United States Patent and
Trademark Office (USPTO) has issued U.S. Patent No. 11,738,120 with
claims directed to the composition of a catheter lock solution for
preventing infection and reduced blood flow in central venous
catheters. This newly issued U.S. Patent, for which CorMedix
previously announced the allowance of patent claims, reflects the
unique and proprietary nature of DefenCath®, and will extend the
Company’s current intellectual property protection with an
expiration date of April 15, 2042.
The newly issued patent claims supplement
CorMedix’s existing licensed U.S. Patent No. 7,696,182, and provide
an additional layer of patent protection for DefenCath. The Company
also expects DefenCath to be eligible for 10.5 years of statutory
marketing exclusivity in the U.S. beginning upon potential FDA
approval of the New Drug Application (NDA), which includes 5 years
for New Chemical Entity designation, an additional extension of 5
years for Qualified Infectious Disease Product designation, and 6
months upon completion of a pediatric hemodialysis clinical trial
post-approval of the NDA. As part of the NDA approval process, the
Company plans to seek listing of patent No. 11,738,120 in FDA’s
publication Approved Drug Products with Therapeutic Equivalence
Evaluations, known as the Orange Book, which identifies approved
drug products and includes related patent and exclusivity
information.
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 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. CorMedix 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. After receiving guidance from FDA at a
Type A meeting in April of 2023, the NDA for DefenCath was
resubmitted. In June of 2023, the resubmitted NDA was accepted for
filing by the FDA. 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, 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
statements. Readers are cautioned that actual results may differ
materially from projections or estimates due to a variety of
important factors, including: the risks and uncertainties related
to market conditions; the ability to secure final FDA approval
prior to July 1, 2024; CorMedix’s ability to manage its cash
resources and the impact on current, planned or future research;
the ability to achieve commercial preparedness ahead of the target
action date in November 2023; and that preclinical results are not
indicative of success in clinical trials and might not be
replicated in any subsequent studies or trials. 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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