WIXOM, Mich., March 5, 2014 (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 that it will host a Key Opinion Leader Breakfast on Thursday, March 6, 2014, beginning at 8:00am Eastern Time, in New York City. Rockwell's management team will provide a brief overview of the Company's strategies to drive long-term growth, and Key Opinion Leader, Anatole Besarb, MD, will discuss how Rockwell's Triferic™, currently under investigation for the treatment of iron replacement in dialysis patients, will play an integral role in the anemia and renal space. Dr. Anatole Besarb is currently a Senior Director of Clinical Research at Fibrogen, Inc., and has an academic appointment as Consulting Professor of Medicine at Stanford University. He was previously Director of Clinical Research in the Division of Nephrology and Hypertension at Henry Ford Hospital, and was also Professor of Medicine at Thomas Jefferson University. Dr. Besarb's research interest is in optimizing the management of anemia, which includes the use of different hematopoietic agents, with a focus on balancing iron and erythropoietic stimulating agents. He served as the Chair and the Co-Chair of the NKF Workgroup on Vascular Access as well as various committees for the FORUM of ESRD networks, including the ASN, NKF, ASAIO, and the NIH. He has authored more than 190 peer-reviewed papers, 28 chapters and 16 monographs. The presentations, followed by a Question-and-Answer session, will be webcast live beginning at 8am Eastern Time. To access the webcast, please go to the Investor Relations section of Rockwell's corporate website at www.RockwellMed.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 and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis.
Rockwell's lead drug candidate Triferic is in late-stage clinical development for the treatment of iron replacement in dialysis patients. Triferic delivers iron to the bone marrow of dialysis patients in a non-invasive, physiologic manner during their regular dialysis treatment, using dialysate as the delivery mechanism. In completed clinical trials to date, Triferic has demonstrated that it can safely and effectively deliver sufficient iron to the bone marrow, maintain hemoglobin and not increase iron stores (ferritin), while significantly reducing ESA dose. Triferic has successfully completed the efficacy trials of its Phase 3 clinical study program (CRUISE-1 and CRUISE-2). Triferic is expected to address an estimated $600M U.S. market.Rockwell is preparing to launch its FDA approved generic drug Calcitriol, to treat 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 launch Calcitriol once it receives FDA manufacturing approval, addressing an estimated $350M U.S. 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. and its operating infrastructure is a ready-made sales and distribution channel that is able to provide seamless integration into the commercial market for its drug products, Calcitriol and Triferic upon FDA market approval. 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. For a demonstration of the Triferic unique mechanism of action in delivering iron via dialysate, please view the animation video at http://www.rockwellmed.com/collateral/documents/english-us/mode-of-action.html. The Rockwell Medical, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=6773 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.
CONTACT: Michael Rice, Investor Relations; 646-597-6979