WIXOM, Mich., Sept. 19, 2011 (GLOBE NEWSWIRE) -- Rockwell Medical (Nasdaq:RMTI), a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease (ERSD), chronic kidney disease (CKD), and iron deficiency anemia, announced today that it has hired Annamaria T. Kausz, M.D., M.S. as Vice President of Drug Development and Medical Affairs. Dr. Kausz will be responsible for leading the new drug application (NDA) submission for Rockwell's Soluble Ferric Pyrophosphate (SFP) upon completion of its on-going Phase III CRUISE studies, as well as overseeing all aspects of clinical research and development for SFP and new drug indications. Dr. Kausz replaces Dr. Richard Yocum.
Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated, "We are very excited to have Dr. Kausz join Rockwell and lead our clinical development program. Her experience is ideal for us. Dr. Kausz was the medical/scientific lead on the NDA submission for Feraheme®, AMAG's intravenous iron product that was FDA approved in 2009, as well as for the subsequent Canadian NDS and European MAA submissions. She has extensive experience in interfacing with regulatory agencies, both U.S. and ex-U.S. She has actively participated in partnership and in-licensing initiatives and has been instrumental in securing ex-U.S. partnerships. Dr. Kausz has extensive hands-on experience in all phases of the clinical development process and in providing clinical oversight across multiple therapeutic indications, both in adult and pediatric populations. Her knowledge and expertise will be a tremendous asset to our team as we prepare to submit our NDA to the FDA for SFP market approval."
Prior to joining Rockwell, Dr. Kausz worked first as Senior Director, Clinical Research and then Executive Director, Clinical Research at AMAG Pharmaceutical, from 2006 to present. Dr. Kausz received fellowship training in Pediatric Nephrology at Children's Hospital and Adult Nephrology at University of Washington, both in Seattle, and earned board certification in both Adult and Pediatric Nephrology. During her fellowship training, Dr. Kausz also received her Master of Science degree in Epidemiology from University of Washington School of Public Health, with a concentration in Biostatistics. Subsequently, she joined Tufts Medical Center, Boston as Staff Nephrologist and has served as Assistant Professor of Medicine at Tufts University School of Medicine, Boston, MA since 1999, where she maintains an outpatient clinic. Dr. Kausz has extensive renal and anemia research experience and her work has been published in numerous peer reviewed publications.
Dr. Anna Kausz, newly appointed Vice President of Drug Development and Medical Affairs of Rockwell commented, "I am extremely excited to join Rockwell Medical. This is an exciting company that I believe has a game-changing iron product to treat anemia. SFP is truly a unique iron product that addresses an important unmet need for dialysis patients throughout the world. My experience in submitting the NDA for Feraheme® and bringing it through the FDA approval process, coupled with Rockwell's SFP clinical development program and the Phase III studies now underway, gives me great confidence there's high potential to achieve SFP market approval. I look forward to working with Rob and the rest of the Rockwell team and advancing SFP into the U.S. commercial market and abroad."
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 to dialysis patients in a non-invasive, physiologic manner via dialysate during their regular dialysis treatment. SFP is currently in ongoing Phase III clinical trials and addresses a $600M U.S. market. Rockwell's Calcitriol (vitamin D injection) for treating secondary hyperparathyroidism will be available in mid-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 for seamless integration into the commercial markets for its drug products, 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, 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.