DefenCath® (taurolidine and heparin) catheter lock solution is indicated to reduce the incidence of catheter-related bloodstream infections (CRBSI) in adult patients with kidney failure receiving chronic hemodialysis (HD) through a central venous catheter (CVC). This drug is indicated for use in a limited and specific population of patients.

CORMEDIX INC. ANNOUNCES ISSUANCE OF U.S. PATENT COVERING LEAD PRODUCT DEFENCATH

August 30, 2023

Berkeley Heights, NJ – August 30, 2023 – 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 Ferry
Managing Director
LifeSci Advisors
(617) 430-7576