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June 23, 2014
16:18 EDTCRMDCorMedix finalizes Phase 3 study protocol with FDA for Neutrolin
CorMedix announced the progress of on-going discussions with the U.S. Food and Drug Administration for a planned pivotal Phase 3 randomized controlled trial for Neutrolin for use in hemodialysis patients with a central venous catheter. CorMedix worked with the FDA to develop the protocol design for the planned trial for a marketing application. Based on FDA input, the planned Phase 3 clinical trial will be a multi-center, randomized, controlled study conducted in the U.S. and Europe. Dr. Michael Allon, Professor, Department of Medicine, Division of Nephrology, University of Alabama, Birmingham will be the Study Chair of the Neutrolin Phase 3 program. In addition, CorMedix has earlier submitted detailed information to TUV-SUD for the purpose of advancing our label expansion in the European Union to include oncology, total parenteral nutrition and intensive care patients. Randy Milby, CEO of CorMedix, stated, "The planned Neutrolin pivotal Phase 3 clinical trial is a major milestone which provides us with a clearly defined development and regulatory pathway for Neutrolin, and we would like to thank the FDA for its invaluable guidance throughout this process. "We believe that Neutrolin is well positioned to unlock significant shareholder value."
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May 19, 2015
14:44 EDTCRMDCourt finds TauroPharm infringed CorMedix patent, utility models
In a regulatory filing earlier, CorMedix announced that it has received written copies of the May 8 decisions of the District Court of Mannheim on CorMedix's patent and utility model infringement cases in Germany related to Neutrolin. The written decisions confirm that the two proceedings brought by CorMedix against TauroPharm have been stayed. The court found that the commercialization by TauroPharm in Germany of its TauroLock catheter lock solutions Hep100 and Hep500 infringes both CorMedix’s patent and utility model, and further that there is no prior use right that would allow TauroPharm to continue to make, use or sell its product in Germany. However, the court declined to issue an injunction based on the likelihood that the European Patent Office, in the case of the patent, or the German Patent and Trademark Office, in the case of the utility model, may find that the patent or utility model is invalid. The court noted the possible publication of certain instructions for product use that may be deemed to constitute prior art. As such, the court will defer consideration of injunction until the EPO or German PTO rules on the underlying validity of the patent/utility model. CorMedix continues to believe that the patent and utility model validly claims inventions.

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