WIXOM, Mich., Oct. 6, 2009 (GLOBE NEWSWIRE) -- Rockwell Medical Technologies, Inc. (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, reported today that it has added Jur Strobos M.D. to its Scientific Advisory Board (SAB). Rockwell's SAB currently advises the Company on clinical development for its proprietary iron-maintenance drug SFP, currently in FDA clinical development.
Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell, stated, "We are delighted to have Dr. Strobos join our SAB. Jur has significant experience as it pertains to both FDA clinical drug development and corporate drug development, and he knows the renal space particularly well. We expect his input will prove to be a great benefit to moving SFP through the FDA process."
Dr. Strobos has extensive scientific and legal training as well as substantial management experience in the pharmaceutical industry. He served as the Director of the Policy Research Staff in the Office of the Commissioner at the U.S. Food and Drug Administration. He worked closely with the Commissioner on regulatory policy, drug promotion, standards for review of clinical studies, drug and medical device review and approval, biological product and human tissue review and approval, international harmonization of review standards, electronic submissions, mammography quality, federal healthcare financing of investigational devices and informed consent. After practicing regulatory law in Washington, DC, Dr. Strobos held executive positions at three pharmaceutical firms as their VP of clinical research and regulatory affairs (two start-ups and one NYSE-listed company). His responsibilities included regulatory affairs, and nonclinical and clinical development of drugs, medical devices, and biological products. Dr. Strobos has been intimately engaged in the creation, filing, and regulatory issues involved in INDs, NDAs, PMAs, and BLAs, including the manufacturing, nonclinical, clinical and regulatory issues. Dr. Strobos has performed a pivotal role in the regulatory and/or clinical strategy of several marketed products, including Ferrlecit, the DePuy ACS Knee, Perlane, Solodyn, Restylane, Hectorol, ResQPOD, as well as many products currently under IND. Dr. Strobos received degrees from Johns Hopkins University (BA/Honors), the University of Chicago Pritzker School of Medicine (MD) and the University of Pennsylvania Law School (JD).
About SFP:
SFP is a novel, investigational, physiological iron maintenance 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, healthy dietary iron uptake. SFP is designed as a continuous replacement treatment delivering small doses of iron during every dialysis session in order to offset iron losses 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 and benefits of recombinant erythropoietin treatment. 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 Technologies:
Rockwell 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 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 www.rockwellmed.com 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.