BERKELEY HEIGHTS, N.J., April 23, 2020 (GLOBE NEWSWIRE) -- 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, today announced that it has entered into a new three-year Employment Agreement with Jack Armstrong, currently Executive Vice President and Head of Technical Operations. The new agreement terminates in April 2023, and may be extended annually thereafter upon mutual agreement. The Employment Agreement was concluded as CorMedix works to secure marketing authorization for Neutrolin® in the second half of 2020 with potential commercial launch in the U.S. in 2021.
“I am delighted that Jack has agreed to continue in his current role at this critical time when we are ramping up our preparations for commercial launch following Neutrolin’s anticipated approval in the second half of 2020,” said Mr. Baluch. “He has been instrumental in building and securing Neutrolin’s supply chain over the past few years, including the sourcing of raw materials, drug product manufacturing and distribution and warehousing. His experience will be critical as we continue our preparations to commercialize Neutrolin, whether on our own or with a strategic or commercial partner.”
Mr. Armstrong joined CorMedix in October 2014. He has more than 40 years of experience in the pharmaceutical industry with broad cross-functional experience in all facets of supply chain and quality assurance, and has held a number of general management positions. Prior to joining CorMedix, Mr. Armstrong was President of Correvio, a private company supplying product to more than 60 countries. His experience includes President & CEO of Genera, a biotech company, as well as executive positions at DuPont Merck and Marion Merrill Dow. He has held roles as a CEO, and in manufacturing, quality assurance, and integrated business systems development, all of which have led to significant experience in business development.
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 for the U.S. market. The Company completed a Phase 3 clinical trial of Neutrolin in patients undergoing chronic hemodialysis, which showed a 71% reduction in catheter-related bloodstream infections (CRBSIs) relative to the heparin control arm (p=0.0006) with a good safety profile. 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. FDA has granted rolling submission and review of portions of the new drug application (NDA) and CorMedix has begun submission of the NDA. 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 whether a second Phase 3 clinical trial for Neutrolin will be required; 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; 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.