WIXOM, Mich., March 06, 2017 (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 for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis, announced today that poster and oral presentations for Triferic have been selected by the Annual Dialysis Conference for presentation at their Annual Meeting, March 11-14, 2017 in Long Beach, CA. Triferic is the Company’s late-stage investigational iron-replacement drug for the treatment of iron deficiency in chronic kidney disease patients receiving hemodialysis. Triferic is the only FDA approved therapy indicated to replace iron and maintain hemoglobin in hemodialysis patients.
Presentation schedule at the ADC meeting:
Ferric Pyrophosphate Citrate (Triferic): One Month Intraperitoneal Toxicology and Toxicokinetic Study
Ajay Gupta MD, John Dillberger Ph.D., Raymond D. Pratt MD and Division of Nephrology, U of Cal Irvine, CA
Rockwell Medical, Inc., Wixom, MI, USA
Sunday, March 12 and Monday, March 13 at 12:00 – 1:00 PM PT
Pharmacokinetics of Triferic Administered IV and Via Dialysate
Raymond D Pratt, MD, Sarah Grimberg and Ajay Gupta, MD
Rockwell Medical, Inc., Wixom, MI, USA
Monday, March 13 at 8:45 AM PT (Slide Forum II, Basic Science)
Pharmacokinetics (PK) of Triferic Administered IV to Healthy Volunteers: Modeling Diurnal Iron and Additivity of Triferic Iron
Raymond D. Pratt, MD, Mark Bush, Ph.D., Scott Brantley, Ph.D. and Ajay Gupta, MD
Rockwell Medical, Inc., Wixom, MI, USA and Nuventra, Durham, NC
Monday, March 13 at 9:15 AM PT (Slide Forum II, Basic Science)
The Annual Dialysis Conference convenes an international group of practitioners and researchers to discuss current developments in the field of dialysis. The conference is designed for health professionals involved in established dialysis programs, as well as those working in new and developing programs.
Triferic is the only FDA approved drug indicated to replace iron and maintain hemoglobin in hemodialysis patients suffering from anemia. Via dialysate during each dialysis treatment, Triferic replaces the 5-7 mg iron loss that occurs in all patients, effectively maintaining their iron balance. Unlike IV iron products, Triferic binds iron immediately and completely to transferrin (carrier of iron in the body) upon entering the blood and it is then transported directly to the bone marrow to be incorporated into hemoglobin, with no increase in ferritin (stored iron and inflammation) and no anaphylaxis, addressing a significant unmet need in overcoming Functional Iron Deficiency (FID) in ESRD patients. Please visit www.triferic.com to view the Triferic mode-of-action (MOA) video and for more information.
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. 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 and globally.
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 U.S. manufacturing/distribution facilities.
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 sell and market Calcitriol and Triferic. 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 registered trademark of Rockwell Medical, Inc.
CONTACT: Michael Rice, Investor Relations; 646-597-6979