SOURCE: Rockwell Medical

Rockwell Medical

November 02, 2009 08:30 ET

Rockwell Medical Presents New Data on Proprietary Iron-Delivery Drug SFP at American Society of Nephrology Annual Meeting

Data Show SFP-Derived Iron Binds Rapidly to Human Transferrin With Potential to Overcome Inflammation-Induced Reticuloendothelial System (RES) Block

WIXOM, MI--(Marketwire - November 2, 2009) - 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, announced today that the Company presented new in vitro data at the American Society of Nephrology (ASN) annual meeting in San Diego, CA on its lead drug candidate Soluble Ferric Pyrophosphate (SFP).

Robert L. Chioini, Chairman and CEO of Rockwell, said, "We are excited to present this new and significant data demonstrating that SFP-derived iron is delivered rapidly to the iron binding sites on apo-transferrin, facilitating the delivery of iron directly to bone marrow."

The study evaluated the kinetics of iron transfer from SFP to apo-transferrin (apo-Tf). Results showed that all available iron present in SFP was delivered to both iron-binding sites on human apo-transferrin, rapidly and completely. Further, 50 percent of iron uptake was complete within one minute, while there was approximately 90 percent saturation of the iron-binding sites on transferrin, the blood plasma protein for iron ion delivery, within 10 minutes.

Ajay Gupta, Chief Scientific Officer of Rockwell, stated, "This in vitro study provides important information about SFP by demonstrating iron kinetics similar to that of ferric-NTA, which is known to transfer iron rapidly and completely to apo-transferrin. These data suggest that SFP has potential to overcome inflammation-induced RES block and iron-induced redox reactions."

The study findings were presented during a poster session at the annual American Society of Nephrology (ASN) Annual Meeting entitled, "Fe (III) Transfer from Soluble Ferric Pyrophosphate (SFP) to Human Apo-transferrin (," on Saturday, October 31, from 10:00 AM - 12:00 PM (Poster SA-PO2433).

For a demonstration of SFP's unique mechanism of action, please view the animation video at

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 replacement 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 has licensed exclusive world-wide rights to manufacture and sell SFP and has secured patents 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 is developing a pipeline of drug therapies, including extensions of SFP for indications outside of hemodialysis. Please visit for more information.

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.

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