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Rockwell Medical Technologies, Inc. Receives Japanese Patent Grant for Proprietary SFP Iron-Delivery
Friday, May 25, 2007
Wixom, MI -- Rockwell Medical Technologies, Inc. , a leading, innovative manufacturer and developer of concentrates and specialty pharmaceuticals focused on the end- stage-renal-disease market (ESRD), reported that the Japanese patent was granted for its proprietary anemia drug, Soluble Ferric Pyrophosphate (SFP). The patent covers the "Method and Pharmaceutical Composition for Iron Delivery administered in Hemodialysis and Peritoneal Dialysis Patients".
Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated, "This is another important patent approval for Rockwell. According to recent data, Japan is the 2nd largest national ESRD market after the United States with approximately 250,000 patients on hemodialysis, growing 6% annually. Coupled with our U.S. and European patents, we have IP protection for SFP in the three largest ESRD markets in the world. We expect to fully capitalize on these markets."
By delivering iron via dialysate during dialysis treatment, Rockwell's proprietary iron-delivery product SFP is designed to provide Physiological Iron Maintenance Therapy in ESRD patients. As opposed to current intravenous (IV) iron delivery, SFP is delivered to the patient in small doses via dialysate solution during the typical three-times-weekly dialysis session, closely matching normal red blood cell maintenance-function. Rockwell has licensed the global rights to SFP and its patents and is in the process of seeking FDA approval to market this innovative maintenance therapy.
Compared to IV iron administration, clinical study results have shown that delivering iron via dialysate is a safe and effective method for maintaining iron balance in dialysis patients, while at the same time eliminating associated nursing and pharmaceutical IV iron administration costs. Rockwell estimates that the U.S. market for IV iron delivery is as much as $450 million annually while the global market potential is approximately $750 million annually. Rockwell expects SFP to compete aggressively for those markets upon FDA market approval. Visit Rockwell's website at http://www.rockwellmed.com/ironnews.htm for more information on SFP.
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 properly and who suffer from chronic kidney failure, a condition also known as end-stage-renal-disease (ESRD). There are an estimated 350,000 dialysis patients in the United States and the incidence of ESRD has increased approximately 6% on average each year over the last decade. Rockwell manufactures, markets and delivers high-quality dialysis solutions, powders and ancillary products that are used to cleanse the ESRD patient's blood and replace nutrients in the bloodstream. Rockwell's proprietary formulations for iron-delivery and vitamin/carnitine-delivery, utilizing its dialysate as the delivery mechanism, are designed to provide replacement therapy with unprecedented patient safety and efficacy while eliminating nursing time and supply cost. Rockwell offers the proprietary Dri-Sate Dry Acid Concentrate Mixing System, RenalPure® Liquid Acid Concentrate, SteriLyte® Liquid Bicarbonate Concentrate, RenalPure® Powder Bicarbonate Concentrate, Blood Tubing Sets, Fistula Needles and a wide range of ancillary dialysis items. Visit Rockwell's website at http://www.rockwellmed.com/ for more information.
Certain statements in this press release including statements regarding FDA approval to market SFP, the market potential for iron supplementation and the ability of SFP to compete for market share once approved by the FDA constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect management's expectations and are based upon currently available information. Management of Rockwell believes the expectations reflected in the forward-looking statements made in this press release are based upon reasonable assumptions. However, certain factors could occur that might cause actual results to vary. These include, but are not limited to, general economic conditions, economic conditions in the hemodialysis industry, modified regulatory requirements, competitive factors, and other factors discussed in Rockwell's reports filed with the Securities and Exchange Commission. The forward-looking statements should be considered in light of these risks and uncertainties.
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