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CorMedix Inc. (CRMD)

CorMedix Inc. is a pharmaceutical company focused on in-licensing, developing and commercializing therapeutic products for the prevention and treatment of cardiac and renal dysfunction, also known as cardiorenal disease. The company’s goal is to treat kidney disease by reducing the commonly associated cardiovascular and metabolic complications, in effect, treating the kidney to treat the heart. CorMedix currently has several product candidates in development.

No drugs are currently marketed for the therapies being targeted by CorMedix. The company’s Neutrolin compound could become the first FDA-approved drug that addresses one of the seven major healthcare challenges, Catheter-Related Bloodstream Infection (CRBI), as defined by the Center for Disease Control (CDC). This challenge represents an approximate $675 million per year revenue opportunity in the United States alone.

The Deferiprone compound is being developed as a therapy for Contrast Induced Nephropathy (CIN) which can lead to morbidity and death. It is already approved and available in a different formulation for sale in 50 countries outside the U.S. as a treatment for iron overload disorders. This compound addresses an approximate $365 million per year revenue opportunity.

Upcoming Expected Neutrolin (CRMD003) Milestones

• 2H 2011: Potential product launching in Europe
• 1H 2012: Release of preliminary data from Pivotal Phase III clinical trial
• 2H 2012: File Premarket Approval (PMA) application in the U.S
• 1H 2013: FDA approval of Neutrolin (CRMD003)

Upcoming Expected Deferiprone (CRMD001) Milestones

• 2H 2011: Phase II data from Deferiprone study
• 2H 2011: Phase III DEFEND-AKI clinical trial (prevention of Contrast-Induced
Nephropathy in patients with Chronic Kidney Disease) – Expected to begin
• 2H 2012: Release of data from Phase III DEFEND-AKI trial
• 4Q 2012: File for New Drug Application (NDA) for Deferiprone (CRMD001)
• 2H 2013: FDA approval of Deferiprone (CRMD001)



Monday, December 13th, 2010 Uncategorized