CORMEDIX PRESENTS AT FDA PUBLIC MEETING ON THE LIMITED POPULATION PATHWAY FOR ANTIBACTERIAL AND ANTIFUNGAL DRUGS
July 17, 2019
Berkeley Heights, NJ – July 17, 2019 – CorMedix Inc. (NYSE American: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, announced today that Dr. Phoebe Mounts, Esq., CorMedix Executive Vice President and General Counsel, presented at a public meeting on July 12, 2019 hosted by FDA discussing the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD). In her presentation, Dr. Mounts recommended several ways in which the LPAD draft guidance for industry issued by FDA could be strengthened, and emphasized the public health importance of the LPAD pathway for novel antimicrobial products such as Neutrolin®.
“We are pleased to have been given the opportunity by FDA to provide our views on the LPAD pathway in this important public forum,” commented Khoso Baluch, CorMedix CEO. “Our participation in this hearing provided us visibility as a potential LPAD beneficiary with the FDA and the pharmaceutical industry. We look forward to discussing in our upcoming quarterly conference call the progress we are making on the regulatory steps required for the Neutrolin NDA filing.”
The LPAD pathway was established by the 21st Century Cures Act and is intended to encourage the development of certain antibacterial and antifungal drugs to help address the critical public health and patient care concern that has resulted from the current decline in antibacterial drug research and development as serious antibacterial and antifungal drug-resistant infections increase. In February 2019, the Company reported that the FDA agreed the Company can request consideration of Neutrolin for approval under LPAD at the time of the filing of the NDA.
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 Neutrolin®, a novel, non-antibiotic antimicrobial solution designed to prevent costly and dangerous bloodstream infections associated with the use of central venous catheters, currently in Phase 3 development for patients undergoing chronic hemodialysis. Such infections cost the U.S. healthcare system approximately $6 billion annually and contribute significantly to increased morbidity and mortality. Neutrolin has FDA Fast Track status and is designated as a Qualified Infectious Disease Product, which provides the potential for priority review of a marketing application by FDA and allows for 5 additional years of QIDP market exclusivity in the event of U.S. approval. Neutrolin is already marketed as a CE Marked product in Europe and other territories. In parallel, CorMedix is leveraging its taurolidine technology to develop a pipeline of antimicrobial medical devices,
with active 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. 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 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 Neutrolin development path, including the need for a second Phase 3 trial; the resources needed to complete the information required to submit a new drug application for Neutrolin to 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 Neutrolin and research for additional uses for taurolidine; obtaining additional financing to support CorMedix’s research and development and clinical activities and operations; risks related to obtaining FDA approval of the new drug application for Neutrolin; relying on preclinical results that may not be 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.