Rockwell Medical Data Safety Monitoring Board Recommends SFP Phase III Efficacy Studies to Continue as Planned
DSMB's Fourth and Final Review Finds No Safety Indication to Alter or Stop SFP Iron Trials
(firmenpresse) - WIXOM, MI -- (Marketwire) -- 12/18/12 -- Rockwell Medical, Inc. (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 the independent Data Safety Monitoring Board (DSMB) providing oversight for the Company's Phase III clinical studies for SFP iron replacement therapy met and unanimously agreed there was no safety issue warranting a change in the trial design or termination of the study. SFP is the Company's lead drug candidate and is nearing completion of its Phase III multi-center clinical trials for use as an iron replacement therapeutic in hemodialysis patients.
Mr. Robert L. Chioini, Chairman and CEO, stated, "We are pleased to receive this positive news from the DSMB and thank them for their effort. As we near completion of our Phase III clinical studies, this fourth DSMB review further strengthens our belief in the safety of SFP. Upon successful completion of the CRUISE 1 and 2 studies we believe that SFP will initiate a new approach to iron therapy and anemia management."
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 lead, late-stage investigational drug for iron therapy treatment is called Soluble Ferric Pyrophosphate (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. and $1B global market. Rockwell's Calcitriol (generic Active Vitamin D) injection for treating secondary hyperparathyroidism is expected to launch in 2013 and addresses 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 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 for more information. For a demonstration of SFP's unique mechanism of action in delivering iron via dialysate, please view the animation video at .
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.
Michael Rice
Investor Relations
201-408-4923 / 917-282-3242
David Connolly
Media Contact
617-374-8800
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Datum: 18.12.2012 - 07:30 Uhr
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