Description of Business

9 Months Ended

Sep. 30, 2014

Description of Business

Description of Business

1.  Description of Business

Rockwell Medical, Inc. and Subsidiary (collectively, “we”, “our”, “us”, or the “Company”) is a fully-integrated pharmaceutical company targeting end-stage renal disease (“ESRD”) and chronic kidney disease (“CKD”) with innovative products and services for the treatment of iron deficiency, secondary hyperparathyroidism and hemodialysis. 

Rockwell’s lead investigational drug Triferic is currently under review by the U.S. Food and Drug Administration (“FDA”) for the treatment of iron replacement and maintenance of hemoglobin in dialysis patients. Triferic’s unique mode of action enables it to deliver iron to the bone marrow of dialysis patients in a physiological manner during their regular dialysis treatment, using dialysate as the delivery mechanism. Triferic has successfully completed the efficacy trials of its Phase 3 clinical study program.

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. 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.

We are regulated by the FDA under the Federal Drug and Cosmetics Act, as well as by other federal, state and local agencies.  We market products that have been approved for sale by the FDA.