Healthcare Industry News: hemodialysis
News Release - February 6, 2008
CorMedix Licenses New Technology to Prevent Infection and Clots in Central Venous CathetersSUMMIT, N.J., Feb. 6, 2008 (Healthcare Sales & Marketing Network) -- CorMedix Inc., a New York-area biopharmaceutical company, announced today that it had acquired exclusive worldwide rights to develop, manufacture and market Neutrolin(r), a liquid that ``locks'' a patient's central venous catheter (CVC) between hemodialysis (HD) sessions to keep it free of infection and clots.
``We hope Neutrolin(r) will be a paradigm-changing weapon in fighting one of the single greatest causes of morbidity and mortality among the 300,000 kidney failure patients in the U.S. who undergo life-sustaining HD treatments,'' said Bruce Cooper, M.D., President and Chief Executive Officer of CorMedix.
More than 25 percent of HD patients rely on a CVC for vascular access. Recent estimates suggest that up to 160,000 new cases of catheter-related blood stream infection (CRBSI) emerge each year in HD alone. At best, these infections result in the need for antibiotics; at worst, they result in catheter replacement, hospitalization and possibly premature death. (American Journal of Kidney Diseases 51 (2) 2008: pp. 165-168)
``Neutrolin(r) contains taurolidine -- a broad-spectrum antimicrobial/antifungal compound along with the anticlotting agents citrate and heparin. These ingredients have the potential to make Neutrolin(r) effective in fighting CRBSI and maintaining catheter patency,'' said Mark Houser, M.D., CorMedix's Chief Medical Officer. ``Heparin -- the standard 'locking solution' for CVCs -- reduces the likelihood of catheter clotting, but not infection. At the moment in the U.S., there is no approved catheter locking solution for the prevention of CRBSI, which represents an urgent medical need.''
As a lead candidate in CorMedix's pipeline, Neutrolin(r) is ``a late-stage product that we expect will soon enter a pivotal study for what could potentially result in a product launch in two to three years,'' said Dr. Cooper. ``While our initial focus is on preventing CRBSI in hemodialysis catheters, Neutrolin(r) may, in the long run, also be useful in preventing infection in catheters used for cancer chemotherapy, intravenous nutrition, intravenous administration of fluids in an intensive-care setting, and other unique applications.'' According to the Center for Disease Control, hospitalizations related to CRBSI add a marginal cost to the health-care system of approximately $25,000 per episode.
Commenting on the CorMedix acquisition, Frank Prosl, B.Sc., M.Eng. -- a consultant who was extensively involved in the prior development of Neutrolin(r) -- said: ``I'm glad to know that future development of this important therapy is in such good professional hands and that I have the opportunity to work with CorMedix to help the product reach the U.S. market.''
CorMedix licensed its exclusive worldwide rights from ND Partners LLC. ``As one of our first licensing/partnership deals, Neutrolin(r) is a harbinger of CorMedix's future activity. We seek to become the preeminent innovator at the 'cardiorenal crossroads' -- the epidemic intersection of cardiovascular disease and kidney disease,'' said Dr. Cooper.
More About the New Technology (Neutrolin(r))
Initial studies have shown that when Neutrolin(r) is placed into both limbs of a CVC at the end of each HD session, it effectively eliminates biofilm and reduces infection by 90 percent or more. More specifically, Neutrolin(r) locks the ``deadspace'' -- approximately 2.5mL per limb of the CVC -- between HD sessions. This broad-spectrum antibacterial/antifungal and anticoagulant combination is active against common and resistant microbes -- including antibiotic resistant strains of Staphylococcus aureus (MRSA), Staphylococcus epidermidis (MRSE) and Enterococcus (VRE) -- and may prevent biofilm and clots from forming inside the CVC. It potentially reduces the need for local and systemic antibiotics and prolongs catheter life.
Based near New York City in Summit, N.J., CorMedix Inc. is a development-stage biopharmaceutical company that focuses on kidney (renal) dysfunction and its cardiovascular complications -- the ``cardiorenal crossroads.'' From this unique vantage point, CorMedix develops novel ways to minimize disease and create value. These may include pharmaceuticals, biologicals, devices and therapy-enabling diagnostics. The company's two foundational technologies address significant unmet needs in kidney disease: (1) how to remove excess labile or ``toxic'' iron associated with chronic kidney disease (CKD) and with kidney damage caused by X-ray dyes (contrast induced nephropathy, or CIN), and (2) how to prevent central venous catheter (CVC) infection (CRBSI) and clotting. CorMedix has exclusive worldwide rights to four products:
-- CMX001 (a series of novel proprietary formulations of the iron- trapping pill deferiprone) is slated to undergo Phase 3 testing to reduce the morbidity and mortality resulting from CIN, and Phase 2 testing for slowing the progression of CKD;
-- CMX002 (a toxic iron biomarker test) supports the development and marketing of CMX001;
-- CMX003 (Neutrolin(r), a taurolidine antimicrobial/anticoagulant liquid that "locks" CVCs) is slated to undergo pivotal trials to keep hemodialysis CVCs free of infection and clotting; and
-- CMX004 (a novel thixotropic gel formulation in pre-clinical stages of development) could extend the benefits of the Neutrolin (r) solution in prevention of CRBSI in many settings, including hemodialysis, cancer chemotherapy and intravenous nutrition.
For more information about CorMedix, visit http://www.cormedix.com.
This press release contains forward-looking statements that involve risks and uncertainties that could cause CorMedix's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements. Among other things, there can be no assurance that any of CorMedix's development efforts relating to its product candidates will be successful, or such product candidates will be successfully commercialized. Other risks that affect forward-looking information contained in this press release include the possibility of being unable to obtain regulatory approval of CorMedix's product candidates, the risk that the results of clinical trials may not support CorMedix's claims, and CorMedix's reliance on third parties to develop its product candidates. The forward-looking statements contained herein represent the judgment of CorMedix as of the date of this press release and CorMedix assumes no obligation to update these forward-looking statements, except as required by law.
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