Healthcare Industry News: hemodialysis
News Release - April 20, 2006
Rockwell Medical Technologies, Inc. Submits SFP Pre-IND Package Containing Phase III Clinical Protocol to FDAWIXOM, Mich., April 20 (HSMN NewsFeed) -- Rockwell Medical Technologies, Inc. (Nasdaq: RMTI ), a leading, innovative dialysis products manufacturer serving the healthcare industry, reported today that it has submitted a pre-IND package to the FDA for their review. This pre-IND package contains Rockwell's Phase III clinical trial protocol for its proprietary iron-delivery product Soluble Ferric Pyrophosphate (SFP). Rockwell's SFP is designed to provide physiological iron replacement in ESRD patients by delivering iron via dialysate during hemodialysis. Pending FDA approval of its IND development plan, the Company anticipates initiating the Phase III clinical trial during the fourth quarter of 2006.
Rockwell has non-clinical safety studies ongoing in support of the SFP product development. Out of a total of 19 non-clinical safety studies, eleven studies have been completed to date, five studies are ongoing and the final three studies are scheduled to begin in May of this year. The final three studies are projected to conclude in the first quarter of 2007.
Based on the results of an FDA approved Phase II study, delivering SFP via dialysate has shown to be a safer and more effective method for maintaining iron balance in dialysis patients, as compared to intravenous iron (IV-iron) administration. Also demonstrated during the study, SFP delivered via dialysate appeared to have a distinct safety advantage for patients in that it transferred the iron load directly from dialysate into the blood plasma, thereby avoiding liver toxicity that may occur during IV-iron administration. The study results also appeared to demonstrate a reduction in the amount of Epoetin-alfa (EPO) needed during the dialysis treatment.
In addition, as compared to IV-iron administration, SFP delivered via dialysate is expected to produce substantial cost savings for dialysis providers by eliminating the nursing time and the medical supplies needed for current IV-iron administration. Cost and liability due to a potential needle- stick is expected to be eliminated as well.
Rockwell has licensed the exclusive rights to the patents for the SFP technology which grant the Company the right to manufacture and market the combination drug/device. Rockwell estimates that the U.S. dialysis market for IV-iron delivery represents $450 million annually while the global market potential is approximately $750 million annually. Upon FDA market approval, Rockwell expects SFP to compete aggressively in those markets. For more information on SFP visit Rockwell's website at http://www.rockwellmed.com/ironnews.htm.
Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated, "We are pleased to have submitted our pre-IND package to the FDA. This submission, including the Phase III protocol, should enable us to save valuable time on our development plan for SFP. Our overall goal is to attain FDA market approval of SFP as quickly as possible so that we can provide a safe and effective delivery method for patients undergoing hemodialysis who require physiological iron replacement."
Rockwell Medical Technologies, Inc. is an innovative leader in manufacturing, marketing, and delivering high-quality dialysis solutions, powders, and ancillary products that improve the quality of care for dialysis patients. Dialysis is a process that duplicates kidney function for those patients whose kidneys have failed to work properly and suffer from chronic kidney failure, a condition also known as end stage renal disease (ESRD). There are an estimated 350,000 dialysis patients in the United States and the incidence of ESRD has increased approximately 6%-8% on average each year over the last decade. Rockwell's products are used to cleanse the ESRD patient's blood and replace nutrients in the bloodstream. Rockwell offers the proprietary Dri-SateŽ Dry Acid Concentrate Mixing System, RenalPureŽ Liquid Acid Concentrate, SteriLyteŽ Liquid Bicarbonate Concentrate, RenalPureŽ Powder Bicarbonate Concentrate, Blood Tubing Sets, Fistula Needles and a wide range of ancillary dialysis items. Visit Rockwell's website at http://www.rockwellmed.com for more information.
Certain statements in this press release with respect to Rockwell's business and operations, including statements regarding an anticipated commencement on the Company's Phase III clinical trial, non-clinical study timelines, FDA approval, the potential of Rockwell's proprietary SFP, etc., constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect management's expectations and are based upon currently available information. Management of Rockwell believes the expectations reflected in the forward-looking statements made in this press release are based upon reasonable assumptions. However, certain factors could occur that might cause actual results to vary. These include, but are not limited to, general economic conditions, economic conditions in the hemodialysis industry, modified regulatory requirements, competitive factors, and other factors discussed in Rockwell's reports filed with the Securities and Exchange Commission. The forward-looking statements should be considered in light of these risks and uncertainties.
Source: Rockwell Medical Technologies
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