WIXOM, MI--(Marketwire - January 14, 2013) - 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, secondary hyperparathyroidism and hemodialysis, announced today that Professor Francesco Locatelli, MD, FRCPB has joined the Company's Scientific Advisory Board (SAB). Rockwell's SAB consists of some of the leading anemia experts worldwide in the renal space and advises the Company on clinical and commercial development of SFP, its late-stage investigational iron-delivery drug currently in Phase 3 clinical study.
Professor Locatelli is an internationally known nephrologist and anemia expert. He is Scientific Director at Alessandro Manzoni Hospital Lecco, Italy where he is Scientific Director of the Department of Nephrology, Dialysis and Renal Transplantation. He is Past President of European Renal Association - European Dialysis and Transplant Association (ERA-EDTA), International Society of Blood Purification (ISBP) and of the Italian Society of Nephrology. He is honorary fellow of Royal College of Physician of London, U.K. (FRCP), International Distinguished Medalist and recipient of the Garabed Eknoyan Award of the National Kidney Foundation (NKF). Prof. Locatelli has served as Chairman of the board of European Best Practice Guidelines (EBPG) and on the boards of National Kidney Foundation, Dialysis Outcome Quality Improvement (NKF-DOQITM), the executive board of directors of Kidney Disease Improvement Outcome (KDIGO) and he is on the board of European Renal Best Practice (ERBP). He was President of World Congress of Nephrology 2009 in Milan. He is current President of International Society of Geriatric Nephrology and Council Member of International Society of Nephrology (ISN). Prof. Locatelli also serves on the editorial staff of numerous journals, including Nephrology Dialysis and Transplantation (NDT) and the Journal of the American Society of Nephrology (JASN).
Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell, stated, "We welcome the addition of Dr. Locatelli to the SAB to assist with our SFP development program in the European nephrology community, and its role in anemia management."
Professor Locatelli, Scientific Director of the Department of Nephrology, Dialysis and Renal Transplantation at Alessandro Manzoni Hospital Lecco, Italy, stated, "I am pleased to join the Rockwell Scientific Advisory Board. SFP is a very promising parenteral iron therapy for treatment of anemia of inflammation in CKD patients. My goal is to provide expertise to Rockwell that will help facilitate getting this promising new drug to dialysis patients throughout Europe, with the intent to address the unmet need in correcting their functional iron deficiency."
About Rockwell Medical:
Rockwell Medical is 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, secondary hyperparathyroidism and hemodialysis.
Rockwell's late-stage investigational drug for iron therapy treatment is called Soluble Ferric Pyrophosphate (SFP). SFP delivers iron to the bone marrow of dialysis patients in a non-invasive, physiologic manner via dialysate during their regular dialysis treatment. In order to prevent or treat anemia, sufficient availability of iron and erythropoietin must be present in the bone marrow to generate healthy red blood cells. SFP is currently in ongoing Phase 3 clinical studies (CRUISE-1 and CRUISE-2) to address an estimated $600M U.S. and $1B global market. Rockwell's Calcitriol (generic Active Vitamin D) injection for treating secondary hyperparathyroidism is FDA approved and expected to launch in 2013, addressing an estimated $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 infrastructure is a ready-made sales and distribution channel to provide seamless integration into the commercial market for its drug products, Calcitriol 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.
Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws, including, but not limited to, Rockwell's intention to launch Calcitriol and SFP following FDA approval. 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 Rockwell Medical 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.