WIXOM, MI--(Marketwired - Jan 7, 2014) - 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 replacement, secondary hyperparathyroidism and hemodialysis, announced today that its abstract "Triferic™ (Soluble Ferric Pyrophosphate) Administered via Dialysate Maintains Hemoglobin and Reduces ESA and IV Iron Requirements in CKD-HD" was selected as the best abstract submitted to the 34th Annual Dialysis Conference to be held in Atlanta, Georgia, February 8-11, 2014. The Company will be presented the Award by the President of the International Society for Hemodialysis during the Award Ceremony.
Rockwell's PRIME study was a nine-month, prospective, randomized, placebo-controlled, double-blinded, multi-center study in United States that randomized 108 patients equally to dialysate containing Triferic™ (iron) versus conventional dialysate. The objective of the study was for patients in both groups to maintain their Hgb between 9.5 - 11.5 g/dL for the duration while adhering to the same erythropoietin stimulating agent (ESA) and IV iron dosing criteria. The PRIME study successfully met its primary endpoint, demonstrating that regular administration of Triferic™ via dialysate reduced the usage of ESA a statistically significant 37.1% compared to placebo, while maintaining iron balance and maximizing iron delivery. Among the hypo-responsive patients in the study, those who do not respond well to ESA therapy, Triferic™ reduced ESA use by 74.4% compared to placebo, including a 9% reduction in baseline ESA in the Triferic™ group. Triferic™ also reduced IV iron requirements by 45% compared to placebo. The significant ESA sparing and IV iron reduction from Triferic™ was observed without an increase in serum ferritin or transferrin saturation, demonstrating that the Triferic™ (iron) being delivered to the patient was being utilized as intended and was not being trapped or stored.
Dr. Raymond Pratt, Chief Medical Officer of Rockwell Medical stated, "We are honored to receive this Award from the President of the International Society for Hemodialysis at this year's 34th Annual Dialysis Conference. Rockwell will donate the money from winning this award to the Nephrology Department at Children's Hospital in Detroit, MI. We are very pleased with the results of the well-run PRIME study. The 11µg/dL Triferic™ dose delivered sufficient iron without increasing iron stores and greatly reduced ESA dose requirements. The safety profile of Triferic™ was similar to placebo and was well-tolerated. The PRIME study results, coupled with the successful CRUISE Phase 3 efficacy results, support our belief that Triferic™ will establish a new paradigm in iron therapy treatment for hemodialysis patients and that upon FDA approval Triferic™ will become the new standard of care in iron therapy."
Triferic™ is a unique iron compound that is delivered to the hemodialysis patient via dialysate, replacing the 5-7 mg of iron that is lost during every dialysis treatment. Triferic™ is introduced into the sodium bicarbonate concentrate on-site at the dialysis clinic, which is subsequently mixed into dialysate. Once in the dialysate, Triferic™ crosses the dialyzer membrane and enters the blood where it immediately binds to apo-transferrin and is taken to the bone marrow, similar to how dietary iron is processed in the human body. In completed clinical trials to date, Triferic™ has demonstrated that it can safely and effectively deliver sufficient iron to the bone marrow, maintain hemoglobin and not increase iron stores (ferritin), while significantly reducing ESA dose.
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 replacement, secondary hyperparathyroidism and hemodialysis.
Rockwell's lead drug candidate Triferic™ is in late-stage clinical development for the treatment of iron replacement in dialysis patients. Triferic™ delivers iron to the bone marrow of dialysis patients in a non-invasive, physiologic manner during their regular dialysis treatment, using dialysate as the delivery mechanism. In completed clinical trials to date, Triferic™ has demonstrated that it can safely and effectively deliver sufficient iron to the bone marrow, maintain hemoglobin and not increase iron stores (ferritin), while significantly reducing ESA dose. Triferic™ has successfully completed the efficacy trials of its Phase 3 clinical study program (CRUISE-1 and CRUISE-2). Triferic™ is expected to address an estimated $600M U.S. market.
Rockwell is preparing to launch its FDA approved generic drug Calcitriol, to treat secondary hyperparathyroidism in dialysis patients. Calcitriol (active vitamin D) injection is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. It has been shown to significantly reduce elevated parathyroid hormone levels. Reduction of PTH has been shown to result in an improvement in renal osteodystrophy. Rockwell intends to launch Calcitriol once it receives FDA manufacturing approval, 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. As one of the two major suppliers in the U.S., Rockwell's products are used to maintain human life by removing toxins and replacing critical nutrients in the dialysis patient's bloodstream. Rockwell has three manufacturing/distribution facilities located in the U.S. and its operating infrastructure is a ready-made sales and distribution channel that is able to provide seamless integration into the commercial market for its drug products, Calcitriol and Triferic™ 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 Triferic™ for indications outside of hemodialysis. Please visit www.rockwellmed.com for more information. For a demonstration of the Triferic™ 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 Triferic™ 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.