WIXOM, Mich., Sept. 9, 2015 (GLOBE NEWSWIRE) — 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 the nationwide commercial availability of Triferic (ferric pyrophosphate citrate). Triferic is the only FDA approved iron product indicated to replace iron and maintain hemoglobin in hemodialysis patients in the United States.
Dr. Steven Fishbane, lead author and Chief, Division of Kidney Diseases and Hypertension, North Shore University Hospital and Long Island Jewish Medical Center, stated, “I’m very excited to be able to provide Triferic to my patients. Having iron delivered at every dialysis treatment that immediately binds to transferrin and that does not induce iron overload is very similar to the slower, natural process in which iron is used in the body to maintain hemoglobin. We have seen the positive benefits Triferic has had on our patients during the clinical studies and now we are excited to have the drug available to treat patients beyond the research setting. Treating patients with a repletion therapy like IV iron has been associated with a variety of risks. Triferic, in contrast, is a true iron maintenance therapy with an exceptional safety profile and is an important new option for treating patients on chronic hemodialysis.”
“We are thrilled to bring Triferic to the U.S. dialysis market,” stated Robert L. Chioini, Founder, Chairman and Chief Executive Officer of Rockwell Medical. “Triferic addresses a major unmet need as it overcomes functional iron deficiency in hemodialysis patients. IV iron is generally given weekly and by design is trapped in the patient’s liver, which leads to iron overload and the functional iron deficiency that is prevalent in patients today. Triferic however replaces iron at every patient treatment and maintains hemoglobin concentration without increasing iron stores, because the iron is used immediately and not stored in the liver. Triferic benefits patients, nurses, doctors and healthcare providers and we are very motivated to commercialize it. We believe Triferic will become the standard of care in iron replacement for dialysis patients.”
Triferic is a unique iron replacement product that is delivered to hemodialysis patients via dialysate, replacing the ongoing iron loss that occurs during their dialysis treatment. Triferic is packaged in 50 mL ampules and added to the master bicarbonate concentrate mix on-site at the dialysis clinic, at a ratio of one 50 mL ampule to each 25 gallons of bicarbonate. This packaging facilitates easy patient dosing by the dialysis staff. Once in dialysate, Triferic crosses the dialyzer membrane and enters the blood where it immediately binds to transferrin and is transported to the erythroid precursor cells to be incorporated into hemoglobin. In completed clinical trials, Triferic has demonstrated that it can effectively deliver sufficient iron to the bone marrow and maintain hemoglobin, without increasing iron stores (ferritin). Please visit www.triferic.com or call Rockwell Medical at 800-449-3353 for more information.
The Centers for Medicare and Medicaid Services (CMS) granted a unique product reimbursement code for Triferic in June 2015. The Q-code (Q9976) became effective on July 1, 2015 and should be used to facilitate the billing process for dialysis organizations using Triferic.
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 recent FDA approved drug Triferic is indicated for iron replacement and maintenance of hemoglobin in hemodialysis patients. Triferic delivers iron to patients during their regular dialysis treatment, using dialysate as the delivery mechanism. In completed clinical trials, Triferic has demonstrated that it safely and effectively delivers sufficient iron to the bone marrow and maintains hemoglobin, without increasing iron stores (ferritin). Rockwell intends to market Triferic to hemodialysis patients in the U.S. dialysis market.
Rockwell’s FDA approved generic drug Calcitriol is for treating 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.
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™ is a trademark of Rockwell Medical, Inc.
CONTACT: Michael Rice, Investor Relations 646-597-6979