6 Nov 2014
FDA Advisory Committee Recommends Rockwell Medical's Triferic for Iron Replacement and Maintenance of Hemoglobin in Hemodialysis Patients
WIXOM, Mich., Nov. 6, 2014 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (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 today announced that the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food & Drug Administration (FDA) recommended that the Phase 3 Triferic efficacy and safety results support a positive benefit/risk to treat iron loss to maintain hemoglobin in patients with hemodialysis-dependent stage 5 chronic kidney disease (CKD). The ODAC voted in favor of Triferic by a vote of 8 to 3.
"We welcome the committee's recommendation supporting a positive benefit/risk of Triferic," stated Robert L. Chioini, Founder, Chairman and Chief Executive Officer of Rockwell. "We look forward to working with the FDA to complete its review of Triferic. We remain committed to addressing the unmet needs in managing patients with chronic kidney disease."
The ODAC reviewed safety and efficacy data from Rockwell's overall clinical program. During the clinical program more than 1,400 patients were treated with Triferic and more than 100,000 individual administrations were given. The results from the clinical trials have shown Triferic to be an effective and highly-differentiated iron delivery therapy with a safety profile similar to placebo.
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 may 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 investigational drug Triferic is currently under NDA review by the FDA for the treatment of iron replacement and hemoglobin maintenance in dialysis patients, with a PDUFA date of January 24, 2015. Triferic delivers iron to dialysis patients during their regular dialysis treatment, using dialysate as the delivery mechanism. In completed clinical trials to date, Triferic has demonstrated that it may 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).
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 market Calcitriol to hemodialysis patients in the U.S. dialysis 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.
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.
Triferic(TM) is a trademark of Rockwell Medical, Inc. / CitraPure(R) is a registered trademark of Rockwell Medical, Inc.
A complete dossier is available upon request. Please contact Commercial
Healthcare Partners for more information. Contact information below:
Jim Usry, Principal
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