Rockwell Medical will Present Data on Triferic Intravenous (IV) Administration at the 19th International Conference on Dialysis in Las Vegas, February 1-3, 2017

PK Study Shows Effective Intravenous Transfer of Iron


WIXOM, Mich., Jan. 26, 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 it will present data on the Pharmacokinetics of Triferic Administered IV and via HD at the Renal Research Institute 19th International Conference on Dialysis February 1-3, 2017 at Caesar’s Palace in Las Vegas. Triferic is the only FDA approved therapy indicated to replace iron replacement and maintain hemoglobin in chronic kidney disease patients receiving dialysis.                                                                                                                                                                                                                               

Presentation Details:

Session Title:  Pharmacokinetics of Triferic Administered IV and via HD
Session Date and Time: Thursday February 2, 2017: 7:00-8:00am Pacific Time
Poster #:  018

Raymond D. Pratt, MD, FACP, Chief Medical Officer for Rockwell Medical stated, “These new data demonstrate that Triferic can be administered intravenously and deliver the same amount of iron that is delivered when Triferic is administered via dialysate, without increasing iron stores. This amount is sufficient to maintain hemoglobin concentrations in hemodialysis patient.”

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 Renal Research Institute
Renal Research Institute is dedicated to advancing therapy options for dialysis patients to provide the highest caliber of care based on advanced clinical technology. Renal Research Institute operates as a subsidiary of Fresenius Medical Care. The 19th International Conference on Dialysis Advances in Kidney Disease is a forum for up-to-date presentations on new technology and therapeutics in the field of kidney disease, emphasizing current issues facing the renal community.  The conference, which is jointly sponsored by the University of Minnesota, will take place February 1-3, 2017 at Caesar’s Palace in Las Vegas, Nevada. For more information refer to http://renalresearch.com/.

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 for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis.

Rockwell’s anemia drug Triferic is the only FDA approved product 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.


            

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