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Rockwell Medical Announces SFP Patent Issuance For Its Proprietary GMP Formulation In The U.S.

WIXOM, Mich., Oct. 26, 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, announced today that it has received notice from the U.S. Patent and Trademark Office for patent issuance on its proprietary GMP formulation for Soluble Ferric Pyrophosphate (SFP), the Company's lead-drug candidate for treating iron deficiency anemia in ESRD patients.

The patent, "Methods for the Preparation and Use of Ferric Pyrophosphate Citrate Chelate Compositions," covers the synthesis and formulation for Rockwell's pharmaceutical-grade SFP formula. The patent provides protection for Rockwell's proprietary SFP formulation through April 17, 2029. Additionally, the patent may be eligible for an extension under 35 U.S.C. 156, which is equal to the period of time from patent issuance to FDA approval. Further patent applications are pending in Europe, Japan and Canada.

"This patent issuance is an important step in strengthening our intellectual property portfolio, while further safeguarding SFP against potential infringement. It also provides patent protection for the multiple indications Rockwell intends to develop using the SFP technology," stated Robert L. Chioini, Chairman, CEO and President of Rockwell Medical.  

About SFP:

SFP is a novel, investigational, continuous iron therapy in late-stage clinical development, designed to treat iron deficiency anemia in ESRD patients.  In contrast to intravenous (IV) iron delivery, SFP is a proprietary, water-soluble iron that travels to the bloodstream and binds directly to apo-transferrin and then travels to bone marrow to assist in forming a healthy red blood cell, similar to normal physiologic dietary iron intake.  SFP is a continuous iron replacement treatment, delivering small doses of iron during every dialysis session, to replenish the 5-7mg of iron lost during the dialysis procedure, thereby maintaining hemoglobin in the target range as per Kidney Disease Quality Outcomes Initiative (KDQOI) recommendations. Clinical trial data to date suggests that SFP, delivered via dialysate during each dialysis treatment, maintains optimal iron balance and avoids liver toxicity while decreasing associated drug administration costs. Academic studies have shown that more frequent maintenance doses of iron improve therapeutic response to erythropoiesis-stimulating agents (ESA's), 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 obtained patent protection 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 $1 billion.

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