Rockwell Medical, Inc, 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 the U.S. Food & Drug Administration (FDA) has approved its drug Triferic for commercial sale as an iron replacement product to maintain hemoglobin in adult patients with hemodialysis dependent chronic kidney disease.

"We are extremely pleased with the FDA approval of Triferic. It is the first drug approved to replace ongoing iron losses and to maintain hemoglobin levels in hemodialysis patients," stated Robert L. Chioini, Founder, Chairman and Chief Executive Officer of Rockwell. "Triferic's unique ability to be delivered via dialysate and to deliver iron without increasing iron stores strengthens its potential to become the market-leading iron therapy treatment for hemodialysis patients. We view today's FDA decision as a major development both for Rockwell and for the entire hemodialysis patient population who now have a significantly better treatment option for addressing their iron losses. We are highly confident in executing a successful commercial launch and penetrating the market. We thank the patients and physicians who participated in our clinical program as well as our highly skilled team of clinical, manufacturing and regulatory professionals."

Dr. Raymond Pratt, Chief Medical Officer of Rockwell stated, "We are very excited about this drug approval. We see Triferic as a paradigm shift in the treatment of anemia. Importantly, Triferic is the first product that can safely allow dialysis patients to maintain target hemoglobin without the need for IV iron. Data suggests that we have been overloading our dialysis patients with IV iron, and this is an increasing concern to the hemodialysis community. Triferic offers a more physiologic way to deliver and maintain iron balance in hemodialysis patients."

The FDA reviewed safety and efficacy data from Rockwell's overall clinical program. During the clinical program more than 1,400 patients were treated with Triferic and more than 100,000 individual administrations were given. The results from the clinical trials have shown Triferic to be an effective and highly-differentiated iron delivery therapy with a safety profile similar to placebo.

For more details, go to: http://ir.rockwellmed.com/releasedetail.cfm?ReleaseID=892797