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Press Release

Rockwell Medical Announces Two Triferic Poster Presentations at American Society of Nephrology Kidney Week 2017 Annual Meeting


Posted on: 30 Oct 17

WIXOM, Mich., Oct. 30, 2017 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI), announced today that two poster presentations for Triferic have been selected by the American Society of Nephrology (ASN) for presentation at the annual Kidney Week meeting Nov. 1-5, 2017, in New Orleans. Triferic is the company’s 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.

Poster presentation schedule at the ASN annual meeting:

Title: Single Ascending Dose Study of Intraperitoneal Triferic® (Ferric Pyrophosphate Citrate) in Patients on Chronic Peritoneal Dialysis
Presenters: Raymond Pratt, M.D., Sarah Grimberg, and Ajay Gupta, M.D.
Time: Saturday, Nov. 4, 10:30AM to 12:00PM CDT
Abstract number: SA-PO654
             
Title: Pharmacokinetics of Ferric Pyrophosphate Citrate (Triferic®) in Pediatric CKD-5HD patients
Presenters: Raymond Pratt, M.D. and Ajay Gupta, M.D.
Time: Saturday, Nov. 4, 10:30AM to 12:00PM CDT
Abstract number: SA-PO813

Raymond D. Pratt, M.D., FACP, Chief Medical Officer of Rockwell Medical stated, “These two studies demonstrate the utility of Triferic as an iron replacement product able to maintain hemoglobin. The peritoneal dialysis study is the first to show Triferic’s ability to deliver iron to PD patients. The pediatric study represents the completion of the first U.S. FDA post-marketing requirement after approval of Triferic. Rockwell is planning to initiate a clinical study in pediatric HD patients in mid-2018 as the second part of the post-marketing commitment.” 

About Triferic
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.

Investor Contact:
Michael Rice
LifeSci Advisors
(646) 597-6979
mrice@lifesciadvisors.com

Media Contact:
Matt Middleman
LifeSci Public Relations
(646) 627-8384
matt@lifescipublicrelations.com

GlobeNewswire
globenewswire.com

Last updated on: 31/10/2017

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