CorMedix Inc. Announces Agreement with NanoProteagen for its Proprietary Nanoparticle Technology, NanoPro™, in combination with CRMD-005 for Pediatric Neuroblastoma
Bedminster, NJ – May 11, 2016 – CorMedix Inc. (NYSE MKT: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, announced today that it has entered into two exclusive research licensing agreements with NanoProteagen, a biopharmaceutical company developing novel therapeutics against undruggable targets in immuno-oncology. Financial terms were not disclosed. Under the agreements, the two companies will use NanoProteagen’s proprietary nanoparticle technology, NanoPro™, to test the feasibility of a novel combination therapy consisting of CRMD-005, a proprietary formulation of taurolidine, and vincristine, a standard of care cytotoxic chemotherapy agent, to a neuroblastoma tumor. Pediatric neuroblastoma is a pediatric orphan disease with an underserved need. CorMedix also was granted an option to obtain an exclusive worldwide license to the technology developed under the agreements.
Neuroblastoma is an adrenal cancer that develops in the nerve cells of the medulla and is the most common extracranial tumor in childhood, usually occurring in infants and children under 10. In vitro studies indicate that taurolidine has a direct and selective antineoplastic effect on glial and neuronal brain tumor cells, and in addition, has been shown to significantly enhance the activity of cytotoxic cancer drugs, including vincristine. The antineoplastic effects of taurolidine are believed to be mediated by programmed cell death (apoptosis). By combining CRMD-005 with NanoPro™, if feasible, the two companies intend to create a powerful therapy that selectively targets tumor cells while minimizing effects on normal cells.
Randy Milby, CorMedix CEO, stated, “Our main strategic focus will continue to be advancing our lead product Neutrolin through Phase III clinical studies in order to gain FDA approval. Meanwhile, we are keen to explore CRMD-005’s effectiveness for a number of different uses, given its unique properties. Published studies highlighting the potential synergy for taurolidine with cytotoxic agents against neuroblastoma and other tumors are very encouraging, and we believe the development of the combination with NanoProteagen’s NanoPro™ nanoparticle technology could result in a highly valuable therapy for this pediatric orphan disease with underserved need.” Surendar Kharbanda, NanoProteagen’s CEO, explained, “The relationship with CorMedix further validates our technology and business model. NanoProteagen seeks to develop and reformulate products in various therapeutic areas, especially immuno-oncology. Through licensing our NanoPro™ technology, we are able to potentially offer pediatric neuroblastoma patients an enhanced therapeutic option. We look forward to working with CorMedix and continuing the efforts to treat unmet needs like neuroblastoma.”
About CorMedix Inc.
CorMedix Inc. is an emerging commercial-stage biopharmaceutical company that initiated a Phase III clinical study of a novel anti-infective solution, Neutrolin in hemodialysis patients in the United States in December 2015. The Company seeks to in-license, develop and commercialize therapeutic products for the prevention and treatment of infectious and inflammatory diseases. CorMedix’s first commercial product in Europe is Neutrolin®, a catheter lock solution for the prevention of catheter related bloodstream infections and maintenance of catheter patency in tunneled, cuffed, central venous catheters used for vascular access in hemodialysis patients, in addition to oncology patients, critical care patients, and patients receiving total parenteral nutrition, IV hydration, and/or IV medications. The FDA has granted Fast Track status to Neutrolin Catheter Lock Solution and also has designated Neutrolin as a Qualified Infectious Disease Product for oncology, hemodialysis, and critical care/intensive care patients, where catheter-related blood stream infections and clotting can be life-threatening. The initial and planned indications aim to address significant needs in catheter-based treatments in the U.S. and the rest of the world. For more information visit: www.cormedix.com.
NanoProteagen is developing novel therapeutics against undruggable targets in immuno-oncology using its proprietary stealth polymeric nanoparticle technology, NanoPro™. Founded by world-renowned cancer researchers and clinicians from Dana-Farber Cancer Institute, Harvard Medical School and Indian Institute of Technology (IIT), NanoProteagen is developing a pipeline of unique drugs which leverage NanoPro™’s directed intranuclear and intracellular delivery of small molecules, peptides, DNA, antibody fragments and whole antibodies to the tumor cell, while significantly minimizing exposure to normal tissues. The company’s strategy is to continue to identify, license and develop new products that offer enhanced therapeutic options to patient populations that may be underserved by existing therapies. For more information visit: www.nanoproteagen.com.
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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: CorMedix’s ability to successfully realize the potential benefits of the agreement with NanoProteagen and to develop CRMD-005; the cost, timing and results of the planned Phase 3 trials for Neutrolin® in the U.S.; obtaining regulatory approvals to conduct clinical trials and to commercialize CorMedix’s product candidates, including marketing of Neutrolin in countries other than Europe; the risks associated with the launch of Neutrolin in new markets; CorMedix’s ability to enter into, execute upon and maintain collaborations with third parties for its development and marketing programs; CorMedix’s ability to maintain its listing on the NYSE MKT; the risks and uncertainties associated with CorMedix’s ability to manage its limited cash resources; the outcome of clinical trials of CorMedix’s product candidates and whether they demonstrate these candidates’ safety and effectiveness; CorMedix’s dependence on its collaborations and its license relationships; achieving milestones under CorMedix’s collaborations; CorMedix’s ability to identify and enter into strategic transactions; CorMedix’s dependence on preclinical and clinical investigators, preclinical and clinical research organizations, manufacturers, sales and marketing organizations, and consultants; and protecting the intellectual property developed by or licensed to CorMedix. 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 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.