WIXOM, Mich., April 19, 2012 (GLOBE NEWSWIRE) -- Rockwell Medical (Nasdaq:RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron deficiency and secondary hyperparathyroidism, announced today that it has hired Raymond Pratt, M.D., as Chief Medical Officer. Dr. Pratt will oversee the clinical development and FDA regulatory process for Rockwell's Soluble Ferric Pyrophosphate (SFP) and manage all aspects of clinical research and development for SFP and new drug indications.
Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated, "We are very pleased to have Dr. Pratt join Rockwell and lead our clinical team. Dr. Pratt has close to 20 years of drug development experience in all phases of the clinical development process and in multiple therapeutic areas, including nephrology. His experience and leadership will be invaluable to us as we go through the process of obtaining FDA market approval for SFP and other future indications. We look forward to the strategic contributions Dr. Pratt will make during this exciting time for Rockwell Medical."
Prior to joining Rockwell, Dr. Pratt worked at Shire Pharmaceutical Development from 2003-2010, as Vice President R&D and the Scientific leader in the Emerging Business Unit and Renal Business Unit. Previous roles at Shire included Vice President Global Clinical Medicine and Global Clinical Affairs and head of U.S. Clinical Development. Dr. Pratt was instrumental in the FDA approval of Fosrenol ESRD indication and CKD non-dialysis indication in the EU and U.S. He was responsible for 3 NDAs as well as multiple EU marketing applications and sNDA's. He has managed 10 different drugs through all stages of global development for Renal and CNS Indications. He was the principal in numerous meetings with multiple divisions at the FDA and was presenter at two FDA advisory committee meetings. Prior to working at Shire, he was Senior Director, Clinical Research and Development at Eisai Medical Research from 1994-2003 where he was head of CNS and Internal Medicine clinical development.
Dr. Pratt received his M.D. from the University of Illinois College of Medicine. He served six years in the U.S. Army Medical Corps including a period as Director, Dialysis Services at the Walter Reed Army Medical Center. He was Assistant Professor at Cornell Medical College and Johns Hopkins University School of Medicine. At Johns Hopkins he was the recipient of a NIH Physician Scientist Award as well as a Shannon Award for new investigators.
Dr. Raymond Pratt, M.D., newly appointed Chief Medical Officer at Rockwell commented, "I am very excited to join Rockwell Medical. I believe SFP is a truly novel method of iron delivery and would greatly benefit dialysis patients throughout the world. It has great potential for several other indications that we intend to pursue and I am looking forward to playing a leadership role in creating an innovative and world class drug company at Rockwell."
About Rockwell Medical:
Rockwell Medical is a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease (ESRD), chronic kidney disease (CKD), and iron deficiency anemia. The Company is currently developing unique, proprietary renal drugs to treat anemia and secondary hyperparathyroidism. Rockwell's lead drug candidate for iron therapy treatment is called SFP. SFP delivers iron in a non-invasive, physiologic manner to dialysis patients via dialysate during their regular dialysis treatment. SFP is currently in ongoing Phase III clinical trials (CRUISE-1 and CRUISE-2) and addresses a $600M U.S. market. Rockwell's Calcitriol (Active Vitamin D) injection for treating secondary hyperparathyroidism is expected to be available commercially later in 2012, addressing a $350M U.S. market.
Rockwell is also an established manufacturer and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the U.S. and abroad. These products are used to maintain human life by removing toxins and replacing critical nutrients in the dialysis patient's bloodstream. Rockwell's operating business is designed as a ready-made sales and distribution channel to provide seamless integration for its drug products into the commercial markets, Calcitriol in 2012 and SFP upon FDA market approval.
Rockwell's exclusive renal drug therapies support disease management initiatives to improve the quality of life and care of dialysis patients and are intended to deliver safe and effective therapy, while decreasing drug administration costs and improving patient convenience. Rockwell Medical is developing a pipeline of drug therapies, including extensions of SFP for indications outside of hemodialysis. Please visit www.rockwellmed.com for more information. For a demonstration of SFP's unique mechanism of action in delivering iron via dialysate, please view the animation video at http://www.rockwellmed.com/collateral/documents/english-us/mode-of-action.html.
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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," "project," "plan", "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 Rockwell Medical's SEC filings. Thus, actual results could be materially different. Rockwell Medical 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.
CONTACT: Michael Rice, Investor Relations, (646) 597-6979