Rockwell Medical Announces FDA Acceptance of Triferic(TM) as Proprietary Trade Name for Investigational Iron-Delivery Drug SFP
Investigational Iron-Delivery Drug Triferic(TM) Intended for Iron Replacement in Chronic Kidney Disease Patients on Hemodialysis; Successful Phase 3 Efficacy Results Support NDA Submission
WIXOM, MI--(Marketwired - Sep 17, 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, today announced the U.S. Food & Drug Administration (FDA) accepted the proposed proprietary trade name Triferic™ for the Company's investigational iron-delivery drug, previously known as Soluble Ferric Pyrophosphate (SFP), which is intended for treating iron deficiency in chronic kidney disease patients receiving hemodialysis. A request for proprietary name review for Triferic™ will be filed with the New Drug Application (NDA) submission.
"Securing Triferic™ as our proposed trade name is yet another important milestone we have accomplished as we continue our advancement towards obtaining FDA marketing approval," stated Rob Chioini, Founder, Chairman and CEO of Rockwell Medical. "Our clinical team continues to work diligently on reviewing the successful Phase 3 CRUISE-1 and CRUISE-2 study data which, together with our successful PRIME study results demonstrating Triferic™ can significantly reduce ESA use, supports our belief that Triferic™ will establish a new paradigm in iron therapy treatment for hemodialysis patients. We believe that upon FDA approval, Triferic™ will become the new standard of care in iron therapy."
Rockwell recently announced successful top-line results from its long-term Phase 3 CRUISE-1 and CRUISE-2 efficacy studies of Triferic™. Triferic™ is the Company's late-stage investigational iron-delivery drug for the treatment of iron deficiency in chronic kidney disease patients receiving hemodialysis. In both studies, Triferic™ met the primary endpoint, demonstrating a statistically significant mean change in hemoglobin from baseline to End-of-Treatment. Additionally, Triferic™ met key secondary endpoints, including maintenance of hemoglobin, maintenance of reticulocyte hemoglobin, and increase in serum iron pre-to-post treatment without an increase in ferritin. In clinical studies to date, SFP has shown a very clean profile. The long-term studies provide clinical data required for the Company to file a NDA with the U.S. FDA for marketing approval of Triferic™.
About Triferic™
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 a 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 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.
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