WIXOM, Mich., Jan. 24 /PRNewswire-FirstCall/ -- 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 today that it has received favorable reports from its pre-clinical safety studies for its proprietary iron-delivery product, Soluble Ferric Pyrophosphate (SFP). The studies are being conducted to support human clinical trials in hemodialysis patients and ultimately FDA market approval for SFP.
Rockwell's pre-clinical safety, pharmacology and toxicology studies have demonstrated favorable results to date. SFP has been tested on multiple species with both long and short term studies on dogs, rats and rabbits with consistent safety results. Genetic toxicity study results were negative, removing any concern about potential carcinogenicity. In reproductive toxicity studies, SFP has had no adverse effects on fertility or on embryo- fetal development, suggesting that it is safe for use in pregnant women. The animals have tolerated doses of SFP that far exceed those that will be given to human patients and the only side effects have been those that are expected and are well known with iron products. With 16 of the 19 studies completed, the pre-clinical testing program is on schedule and is projected to conclude in the first half of 2007.
On the basis of what the Company considers a strong safety profile, it is preparing to commence human clinical trials consisting of a multi-center nine month dose ranging study followed by a final clinical study. Upon favorable results from both studies, the Company would anticipate receiving FDA market approval sometime thereafter.
Rockwell's proprietary iron-delivery product, SFP, is a soluble form of iron designed to provide physiological iron maintenance therapy in ESRD patients by delivering iron via dialysate during dialysis treatments. A previous human clinical study compared SFP via dialysate to intravenous (IV) iron administration. SFP via dialysate was shown to be 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. Furthermore, recent academic studies have shown that more frequent maintenance doses of intravenous iron prevent development of iron deficiency and improve the therapeutic benefits of recombinant erythropoietin treatment. Regular administration of SFP via the dialysate has also been shown to prevent the development of iron deficiency and is likely to have similar therapeutic benefit.
Rockwell has licensed the exclusive world-wide rights to the SFP patents and is in the process of seeking FDA approval to market SFP. Patents for SFP have been issued in the United States and the European Union and are currently under review in Japan, 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.
Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated, "As we expected, the results of these safety, pharmacology and toxicology studies have demonstrated the exceptional safety profile of SFP. This testing has confirmed results of the Phase II study, where SFP was shown to be very safe as demonstrated by the absence of any adverse reactions over a six month period. Based on theoretical calculations, SFP should have the smallest potential release of free iron of any known iron compound, since iron in SFP is very tightly complexed to pyrophosphate."
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(R) Liquid Acid Concentrate, SteriLyte(R) Liquid Bicarbonate Concentrate, RenalPure(R) Powder Bicarbonate Concentrate, Blood Tubing Sets, Fistula Needles and a wide range of ancillary dialysis items. Visit Rockwell's website at www.rockwellmed.com for more information.
Certain statements in this press release with respect to Rockwell's SFP product, including statements regarding status and timing of Rockwell's efforts to obtain FDA approval of SFP, the safety and effectiveness of SFP, the market potential for SFP and the potential of Rockwell's proprietary Soluble Ferric Pyrophosphate (SFP) to capture market share, etc. constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. 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, any breach of a contract by a major customer, 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.
Rockwell Medical Technologies, Inc.CONTACT: Ron Aubrey, Investor Relations, +1-866-565-6139, or Thomas Klema,+1-248-960-9009, both of Rockwell Medical Technologies, Inc.
Web site: http://rockwellmed.com/
