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Rockwell Medical Announces Triferic(TM) Phase 3 CRUISE Studies Published in Nephrology Dialysis Transplantation

WIXOM, Mich., July 15, 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 publication of the Triferic Phase 3 CRUISE studies (CRUISE 1 and 2) in Nephrology Dialysis Transplantation (NDT). Triferic is the only FDA approved iron product indicated for delivery via dialysate 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 see this Triferic data published. Our study is important and should be of interest to the entire renal community, including patients, because it shows Triferic is an effective iron agent that is able to maintain hemoglobin without inducing iron overload. Triferic is administered at each dialysis session and its iron is immediately donated to transferrin, very similar to the slower natural way iron is used in the body to maintain hemoglobin. Until Triferic, patients undergoing dialysis have been treated almost exclusively with IV iron for their iron replacement, which injects a large amount of iron directly into the blood stream and gets sequestered in the liver resulting in higher and higher ferritins, and which has been associated with a risk of oxidative stress, inflammation, infection, anaphylaxis and tissue iron overload. I believe Triferic is an important new option for iron replacement therapy in patients on chronic hemodialysis."

Dr. Raymond Pratt, MD FACP, Chief Medical Officer of Rockwell Medical stated, "We are very pleased with the publication of the Phase 3 CRUISE study results in NDT. The study data demonstrates that Triferic is the ideal vehicle to deliver iron and maintain hemoglobin concentration in the HD population, and that it is able to do so without increasing ferritin is a direct result of the iron being immediately utilized for hemoglobin synthesis, avoiding the liver sequestration that occurs with IV iron. Importantly, the safety profile of Triferic, in these two large-scale studies demonstrates a favorable benefit-to-risk ratio for hemodialysis patients."

"We are thrilled to see the CRUISE study results published in a premier peer-reviewed nephrology journal," stated Robert L. Chioini, Founder, Chairman and Chief Executive Officer of Rockwell Medical. "Triferic has a unique mode-of-action that enables it to deliver iron immediately and consistently over every patient treatment, without increasing iron stores. As a result, we see Triferic providing optimal patient safety and efficacy benefit as well as significant cost savings in dialysis care. We expect Triferic will become the standard of care for iron delivery for hemodialysis patients in the U.S., and ultimately world-wide."

The CRUISE studies were randomized, single blind, placebo controlled, efficacy and safety studies in chronic hemodialysis patients. Triferic was added to the bicarbonate hemodialysis concentrate while placebo patients received standard hemodialysate without Triferic. A total of 599 patients participated in both studies with 290 randomized to receive Triferic and 295 to placebo. Patients completed the Phase 3 study when they met pre-specified anemia centered criteria or lasted 48 weeks without achieving the criteria. After completing randomized treatment, patients entered open-label treatment.

The primary objective of the CRUISE studies was to determine whether regular administration of Triferic via dialysate could maintain hemoglobin concentrations by optimizing iron delivery and maintaining iron balance. The primary endpoint was the mean change in hemoglobin from baseline to the end-of-treatment (EoT) defined as the average of all hemoglobin values obtained during the last one-sixth (1/6th) of the time spent in the randomized stage of treatment (Stage 2). Both studies successfully met the primary endpoint with a treatment difference of 0.4 g/dL in hemoglobin concentration in favor of Triferic (P=0.011 for individual studies, 95% confidence interval 0.1 to 0.6 g/dL). During the randomized treatment phase, hemoglobin concentrations remained stable in the Triferic treated group while declined in the placebo group. The safety profile of Triferic was similar to placebo treated patients, with both groups experiencing similar proportions of adverse events. The most frequent adverse event was procedural hypotension which was present in 21.6% of Triferic patients and 19.2% of placebo treated patients. No serious adverse events or deaths were attributed to Triferic.

The CRUISE article, Ferric pyrophosphate citrate (Triferic) administration via the dialysate maintains hemoglobin and iron balance in chronic hemodialysis patients. Steven N. Fishbane; Ajay K. Singh; Serge H. Cournoyer; Kailash K. Jindal; Paolo Fanti; Carrie D. Guss; Vivian H. Lin; Raymond D. Pratt; Ajay Gupta. Nephrology Dialysis Transplantation 2015; doi: 10.1093/ndt/gfv277, can be accessed at the following link to NDT Advanced Access: http://ndt.oxfordjournals.org/cgi/reprint/gfv277?ijkey=W5tQrEmf8zb03Q9&keytype=ref .

About Triferic

Triferic is a unique iron compound that is delivered to hemodialysis patients via dialysate, replacing the ongoing iron loss that occurs during their dialysis treatment. Triferic is introduced into bicarbonate concentrate, on-site at the dialysis clinic, and subsequently mixed into dialysate. 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 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. 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; 646-597-6979Source:Rockwell Medical, Inc.

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