CORMEDIX INC. ANNOUNCES NOTICE OF ALLOWANCE FOR U.S. PATENT APPLICATION COVERING LEAD PRODUCT DEFENCATH
May 1, 2023
Berkeley Heights, NJ – May 1, 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) allowed its patent claims directed to the composition of a catheter lock solution for preventing infection and also preventing reduced blood flow in central venous catheters. CorMedix’s newly allowed U.S. Patent Application (No. 17/721,699) reflects the unique and proprietary formulation of its product, DefenCath™, for which the Company expects to resubmit its New Drug Application (NDA) to the Food and Drug Administration (FDA) by mid-May.
Joe Todisco, CorMedix CEO stated “We are pleased to have received this Notice of Allowance that highlights the novelty of DefenCath which has been formulated and demonstrated in clinical trials to reduce Catheter Related Bloodstream Infections (CRBSIs) in hemodialysis patients with central venous catheters. As we updated last week, CorMedix intends to resubmit the DefenCath NDA by mid-May and is focused on building out plans for commercialization following an anticipated FDA approval later this year.”
The newly allowed application provides patent coverage that supplements CorMedix’s existing licensed U.S. Patent No. 7,696,182, and has the potential to provide an additional layer of patent protection for DefenCath through 2042. 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 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 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.
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 subsequently announced its intention to resubmit the NDA for DefenCath by mid-May of 2023. 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.
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 CorMedix’s plans for a resubmission of its DefenCath NDA, the timing of such resubmission, the manufacturing pathways for resubmission, the classification and timing of NDA resubmission, the results of an FDA prior approval inspection as part of the NDA review process, and the timing and qualification of an alternative manufacturing site, 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: results of an FDA inspection; the ability of the Company’s resubmission to be classified as Class 2 and the timing of review; the ability of an alternate CMO to provide data by the end of the third quarter of 2023 and ability of the Company to qualify an alternate CMO as an alternate manufacturing site; the ability of the Company’s heparin supplier to address the manufacturing deficiencies identified in the warning letter for non-heparin API; 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 or obtain CMS approval of a resubmitted NTAP application; 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 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. 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.