Rockwell Medical Announces Iron Delivery Drug SFP Meets Goals

WIXOM -- Rockwell Medical (Nasdaq: RMTI) Monday announced successful results from a clinical study of Soluble Ferric Pyrophosphate, its investigational iron-delivery drug now in Phase 3 clinical studies for the treatment of iron deficiency in hemodialysis patients.

Rockwell Medical is a fully integrated biopharmaceutical company targeting end-stage renal disease and chronic kidney disease with innovative products and services for the treatment of iron deficiency, secondary hyperparathyroidism and hemodialysis.

The study demonstrated that regular administration of SFP-iron via dialysate reduced the usage of erythropoietin stimulating agents (ESAs) during hemodialysis by 37.1 percent while maintaining iron balance and maximizing iron delivery.

The study was a nine-month, prospective, randomized, placebo-controlled, double-blinded, multi-center study in United States involving 108 patients

The primary objective of the study was to determine whether regular administration of SFP via dialysate reduced the requirement for ESA dose by maintaining iron balance and optimizing iron delivery.

Further analysis of the complete data set is ongoing and the company plans to submit data results for presentation at a major medical meeting later in 2013.

SFP is a unique iron compound that is delivered to the hemodialysis patient via dialysate replacing the 5-7mg of iron lost during a dialysis treatment. SFP is introduced into the sodium bicarbonate concentrate that subsequently is mixed into dialysate. Once in the dialysate, SFP crosses the dialyzer membrane and enters the bloodstream where it immediately binds to apo-transferrin and is taken to the bone marrow. SFP mimics the way dietary iron is handled in the human body. In completed clinical trials to date, SFP has demonstrated that it can safely deliver iron and maintain hemoglobin levels, while decreasing ESA use without any increase in iron stores.

Rockwell's lead drug candidate in late-stage clinical development is for the treatment iron deficiency and is called Soluble Ferric Pyrophosphate. SFP delivers iron to the bone marrow of dialysis patients in a non-invasive, physiologic manner via dialysate during their regular dialysis treatment. In order to prevent or treat anemia, sufficient availability of iron and erythropoietin must be present in the bone marrow to generate healthy red blood cells, and in completed clinical trials to date SFP has demonstrated that it can safely deliver iron to the bone marrow. SFP is currently in ongoing Phase 3 clinical studies to address a market estimated at $600 million in the United States and $1 billion worldwide a year.

Rockwell is also preparing to launch a FDA approved generic drug called Calcitriol.  Calcitriol is active vitamin D injection and indicated for the treatment of secondary hyperparathyroidism in dialysis patients. Rockwell intends to enter the vitamin D market in 2013, addressing a market estimated at $350 million a year in the U.S.

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. These products are used to maintain human life by removing toxins and replacing critical nutrients in the dialysis patient's bloodstream. Rockwell's three manufacturing and distribution centers in the United States 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 SFP 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 SFP for indications outside of hemodialysis.  Please visit www.rockwellmed.com for more information. For a demonstration of SFP's unique mechanism of action in delivering iron via dialysate, please view the animation video at www.rockwellmed.com/collateral/documents/english-us/mode-of-action.html.