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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

globin in the SFP arm while hemoglobin decreases in the placebo arm." 

Mr. Robert L. Chioini , Chairman, CEO and President of Rockwell stated, "We are extremely pleased with the results of the PRIME study.  We believe that SFP's unique ability to treat iron deficiency while dramatically reducing the need for ESA, without increasing iron stores, strengthens SFP's potential to become the market leading iron therapy treatment for CKD-HD patients.  SFP's ability to substantially reduce ESA use in the treatment of anemia should translate into significant cost savings in dialysis care while potentially lowering the serious risks associated with the dosing of ESAs. We sincerely thank the study investigators and coordinators, and our clinical team for a well-conducted PRIME study, and we look forward to the upcoming efficacy results from the Phase 3 CRUISE studies, which are expected to read-out in the 2nd-half of this year."

About SFP

SFP is a unique iron compound that is delivered to the hemodialysis patient via dialysate replacing the 5-7mg of iron lost during a dialysis treatment. SFP is introduced into the sodium bicarbonate concentrate that subsequently is mixed into dialysate.  Once in the dialysate, SFP crosses the dialyzer membrane and enters the bloodstream where it immediately binds to apo-transferrin and is taken to the bone marrow.  SFP mimics the way dietary iron is handled in the human body.  In completed clinical trials to date, SFP has demonstrated that it can safely deliver iron and maintain hemoglobin levels, while decreasing ESA use without any increase in iron stores.

About Rockwell Medical:

Rockwell Medical is a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron deficiency, secondary hyperparathyroid
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