WIXOM, Mich., Feb. 23, 2011 (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, today announced that Rob Chioini, Chairman and Chief Executive Officer, along with Dr. Ajay Gupta, Chief Scientific Officer, will present at the Citi 2011 Global Health Care Conference taking place on March 1 – 3, 2011, at the Hilton New York Hotel.
Rockwell's presentation will be on Tuesday, March 1, at 1:30pm ET. The Company will present on the two upcoming Phase III clinical trials for their proprietary iron-therapy drug SFP, as well as on their current operating business and the role that it will play in marketing the drug upon FDA approval, under the new CMS bundled-reimbursement environment. A live webcast and 90-day archive of the presentation will be available at http://www.veracast.com/webcasts/citigroup/healthcare2011/23110155.cfm .
About CRUISE Phase III Trials:Rockwell will conduct two pivotal Phase III trials for SFP. Each study is a prospective, randomized, double-blinded, placebo-controlled, multicenter study to demonstrate efficacy and safety of SFP-iron, delivered via dialysate in adult CKD patients requiring hemodialysis. Each study will comprise 300 patients, randomized equally between SFP and placebo groups over a period of up to 12 months. 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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