WIXOM, Mich., April 15, 2010 (GLOBE NEWSWIRE) -- Rockwell Medical (Nasdaq:RMTI), a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease (ESRD), chronic kidney disease (CKD), and iron deficiency anemia, reported today that it has added Ajay Singh, MBBS, FRCP (UK), MBA to its Scientific Advisory Board (SAB). Rockwell's SAB currently advises the Company on clinical development for its investigational, continuous iron-maintenance drug SFP, currently in FDA clinical development.
Dr. Ajay Singh is an Associate Professor of Medicine at Harvard Medical School and has previously served as Clinical Chief of the Renal Division and Medical Director of the Dialysis Program at Brigham and Women's Hospital, Boston from 1998-2008. His major research interests are in the area of renal anemia and ESA, and he was the principal investigator of the CHOIR study. Dr. Singh has published over 100 peer reviewed journal articles, books and book chapters and is a member of the Editorial Boards of Kidney International and Journal of American Society of Nephrology. Dr. Singh has served as an expert witness to the House Ways and Means Committee of the U.S. House of Representatives, as an Invited Guest of CDRAC at the FDA and as an Expert presenter at the Medicare Evidence Development and Coverage Advisory Committee.
Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated, "We are especially pleased to have Dr. Singh join our SAB as he brings a wealth of experience and exceptional perspective in the field of renal anemia and ESA utilization. We are confident that his input will be a great benefit to SFP clinical development as we move into Phase III development."
Dr. Ajay Singh, Associate Professor of Medicine at Harvard Medical School, commented, "My thanks to Mr. Chioini and the Rockwell team for inviting me onto their Scientific Advisory Board. My goal will be to provide independent advice to Rockwell helpful in developing novel therapies of benefit to our patients with kidney disease."
About SFP:
SFP is a novel, investigational, continuous iron therapy designed to treat iron deficiency anemia in ESRD patients. SFP is a proprietary, water-soluble form of iron that travels directly to the bloodstream and transfers iron at a cellular level, similar to normal physiologic dietary iron intake. SFP is designed as a continuous maintenance treatment delivering small doses of iron during every dialysis session in order to replenish iron lost during the dialysis procedure, thereby maintaining hemoglobin in the target range as per Kidney Disease Quality Outcomes Initiative (KDQOI) recommendations. Clinical trials to date suggest that SFP, delivered during each dialysis treatment via dialysate, maintains optimal iron balance and avoids liver toxicity while decreasing associated drug administration costs. Recent academic studies have shown that more frequent maintenance doses of iron improve the therapeutic response to erythropoiesis-stimulating agents (ESA), thereby decreasing the ESA doses needed to maintain hemoglobin in the target range. Rockwell Medical has licensed exclusive world-wide rights to manufacture and sell SFP and patents have issued for SFP in multiple countries, including the three largest dialysis markets in the world: the United States, Japan, and the European Union. Based on current market data, the U.S. dialysis market for IV iron is approximately $560 million annually while global market potential is approximately $850 million.
About Rockwell Medical:
Rockwell Medical is a fully-integrated biopharmaceutical company offering innovative products and services initially targeting end-stage renal disease (ESRD), chronic kidney disease (CKD), and iron deficiency anemia. An established manufacturer and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the U.S. and abroad, Rockwell provides products that are used to maintain human life by removing toxins and replacing critical nutrients in the dialysis patient's bloodstream. Dialysis is a process that duplicates kidney function for patients who suffer from ESRD. There are approximately 400,000 ESRD patients in the United States, a prevalence growing at an annual rate of 4 percent, and approximately 2 million ESRD patients world-wide.
The Company is currently developing unique, proprietary renal drug therapies for iron treatment. 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, while decreasing drug administration costs and improving patient convenience. Rockwell Medical is developing a pipeline of drug therapies, including extensions of SFP for indications outside of hemodialysis. Please visit www.rockwellmed.com for more information.
The Rockwell Medical Technologies, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=6773
Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "projected," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Rockwell's SEC filings. Thus, actual results could be materially different. Rockwell expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.