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Rockwell Medical Announces Iron Delivery Drug SFP Meets Primary Endpoint in PRIME Clinical Study Demonstrating Statistically Significant 37% Reduction in ESA Dose
Date:2/4/2013

ism and hemodialysis. 

Rockwell's lead drug candidate in late-stage clinical development is for the treatment iron deficiency and is called Soluble Ferric Pyrophosphate (SFP).  SFP delivers iron to the bone marrow of dialysis patients in a non-invasive, physiologic manner via dialysate during their regular dialysis treatment. In order to prevent or treat anemia, sufficient availability of iron and erythropoietin must be present in the bone marrow to generate healthy red blood cells, and in completed clinical trials to date SFP has demonstrated that it can safely deliver iron to the bone marrow.  SFP is currently in ongoing Phase 3 clinical studies (CRUISE-1 and CRUISE-2) to address an estimated $600M U.S. and $1B global market. 

Rockwell is also preparing to launch a FDA approved generic drug called Calcitriol.  Calcitriol is active vitamin D injection and indicated for the treatment of secondary hyperparathyroidism in dialysis patients. Rockwell intends to enter the vitamin D market in 2013, addressing an estimated $350M U.S. market. 

Rockwell is also an established manufacturer and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the U.S. and abroad.  These products are used to maintain human life by removing toxins and replacing critical nutrients in the dialysis patient's bloodstream.  Rockwell's has three manufacturing and distribution facilities in the United States and its operating infrastructure is a ready-made sales and distribution channel that is able to provide seamless integration into the commercial market for its drug products, Calcitriol and SFP upon FDA market approval. 

Rockwell's exclusive renal drug therapies support disease management initiatives to improve the quality of life and care of dialysis patients and are intended to deliver safe and effective therapy, while decreasing dr
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SOURCE Rockwell Medical
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