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Rockwell Medical Technologies, Inc. Receives Patent Grant for Proprietary SFP Iron-Delivery in Mexico
Tuesday, October 23, 2007
Wixom, MI -- Rockwell Medical Technologies, Inc. (Nasdaq:RMTI), a leading, innovative manufacturer and developer of renal drug therapies and essential dialysate products, focused on the end-stage-renal-disease (ESRD) market, reported that a Mexican patent was granted for its proprietary drug, Soluble Ferric Pyrophosphate (SFP). The Mexican SFP patent grant 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, "We are pleased to add Mexico, estimated to be the 8th largest ESRD market in the world, to further strengthen and protect our proprietary intellectual property for SFP worldwide. In conjunction with the successful completion of our SFP clinical development program, we look to expand into the worldwide markets through the development of our own distribution channels and/or with an established international marketing partner."
About Soluble Ferric Pyrophosphate (SFP) -- Rockwell's Lead Renal Drug Therapy
SFP is a water soluble form of iron designed to provide physiological-iron-maintenance-therapy for anemic ESRD patients. SFP (iron) is uniquely delivered via dialysate directly to the bloodstream, during each kidney dialysis treatment. SFP is a highly stable, non-polymeric iron salt that is administered directly into the bloodstream, avoiding liver toxicity build-up thus 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 which facilitates transfer of iron from transferrin to ferritin, bypassing the liver entirely.
Based on previous FDA Phase II clinical study results and compared to intravenous (IV) iron administration, SFP delivered via dialysate, has shown to be a safe and effective method for maintaining optimal iron balance in dialysis patients while at the same time decreasing associated nursing and pharmaceutical IV iron administration costs. Furthermore, recent academic studies have shown that more frequent maintenance doses of iron improve the therapeutic response and benefits of recombinant erythropoietin treatments.
Rockwell has licensed the exclusive world-wide rights to SFP and is collaborating with the FDA in its development. Rockwell has secured patents for SFP in multiple countries, including the United States, Japan, and the European Union, covering the largest commercial markets for iron supplementation in the world. Rockwell has issued and pending patents in a number of other markets as well. Rockwell estimates that the U.S. dialysis market for IV-iron delivery is approximately $450 million annually while global market potential is approximately $750 million.
About Rockwell Medical
Rockwell Medical Technologies, Inc. is a leading, innovative manufacturer and developer of renal drug therapies and critical products focused on improving the quality of care for dialysis patients. Dialysis is a process that duplicates kidney function for those patients 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 1.6 million ESRD patients world-wide. Rockwell's products are used to maintain life, removing toxins and replacing nutrients in the dialysis patient's bloodstream. Rockwell has licensed and is currently developing proprietary renal drug therapies for both iron-delivery and carnitine/vitamin-delivery utilizing its dialysate as the delivery mechanism. These exclusive renal drug therapies support disease management initiatives to improve the quality of life and care of dialysis patients and are designed to deliver safe and effective therapy to these patients while decreasing nursing time and supply cost. The Company 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 www.rockwellmed.com for more information.
Certain statements in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. When we use words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "projected," "intend" or similar expressions, or make statements regarding our intent, belief, or current expectations, we are making forward-looking statements. While we believe these forward-looking statements are reasonable, you should not place undue reliance on any such forward-looking statements which are based on information available to us on the date of this release. Because these forward looking statements are based upon estimates and assumptions that are subject to significant business, economic and competitive uncertainties, many of which are beyond our control or are subject to change, actual results could be materially different. Factors which could cause such a difference include, without limitation, the risk factors set forth in the Company's SEC filings, including its Form 10-Q for the quarter ended June 30, 2007 and its Form 10-KSB for the year ended December 31, 2006. The forward- looking statements should be considered in light of these risks and uncertainties. We do not undertake, and expressly disclaim any obligation, to update or alter our statements whether as a result of new information, future events or otherwise, except as required by law.
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