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Rockwell Medical Technologies, Inc. Begins Dosing Patients for SFP Phase IIb Clinical Study
Date:10/3/2007

is a highly stable and non-polymeric iron salt and is designed to be administered directly into the bloodstream, overcoming the need for iron release from reticuloendothelial stores in the liver and other organs. The ferric iron core is tightly chelated to a pyrophosphate shell, that facilities transfer of iron from transferrin to ferritin, by-passing the liver. Compared to intravenous (IV) iron administration, previous human clinical study results indicate that SFP can deliver iron (via dialysate) safely and effectively and can maintain iron balance in dialysis patients within the target range, while at the same time decreasing associated nursing and pharmaceutical IV iron administration costs. Recent academic studies have shown that more frequent maintenance doses of iron improve the therapeutic benefits of recombinant erythropoietin treatments.

Rockwell has licensed the exclusive world-wide rights to SFP and is seeking FDA market approval. Patents for SFP have been secured in the United States, Japan and the European Union covering the three largest commercial markets for iron supplementation. Rockwell estimates that the U.S. dialysis market for IV iron delivery is approximately $450 million annually while the global market potential is approximately $750 million annually.

About Rockwell Medical

Rockwell Medical Technologies, Inc. is a leading, innovative manufacturer and developer of concentrates and specialty pharmaceuticals focused on improving the quality of care for dialysis patients. Dialysis is a process that duplicates kidney function for those patients whose kidneys have failed to work and who suffer from chronic kidney failure, a condition also known as end-stage-renal-disease (ESRD). There are an estimated 360,000 ESRD patients in the United States growing approximately 4-5% on average each year. There are approximately 2 million ESRD patients world-wide. Rockwell's products are used to maintain life, cleaning blood and replacing nut
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SOURCE Rockwell Medical Technologies, Inc.
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