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WIXOM, Mich., July 8, 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 successfully completed an End of Phase II meeting with the U.S. Food and Drug Administration (FDA) regarding the Company's lead drug candidate Soluble Ferric Pyrophosphate (SFP), a novel continuous iron-replacement therapy designed to treat iron deficiency anemia in hemodialysis patients.
During the meeting, Rockwell solicited input on the Company's planned Phase III clinical program for SFP. As a result of those conversations with the FDA, Rockwell has confirmed a change in hemoglobin is an approvable endpoint for the Phase III trial design. The Company will now use data from the prior Phase IIb study of SFP to finalize the Phase III protocol for FDA submission.
"Meeting with the FDA to review our Phase IIb data and solicit input for our planned Phase III program was an important corporate and clinical milestone," said Robert L. Chioini, Chairman, CEO and President of Rockwell. "The FDA provided clear and valuable feedback for our proposed Phase III program and we now have an acceptable endpoint for our Phase III trial design. We are incorporating the FDA's comments into a final protocol design, which will be submitted shortly, and we expect to remain on track to initiate the Phase III program later this year."
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.