Robert L. Chioini, Founder, Chairman and CEO Thomas E. Klema, Vice President, CFO, Treasurer and Secretary Ajay Gupta, M.D., Chief Scientific Officer
Rockwell Medical Inc. is a publicly traded (NASDAQ: RMTI) biopharmaceutical company founded in 1996 in Michigan. Rockwell focuses on development and commercialization of treatments against diseases such as end-stage renal disease (ESRD) and chronic kidney disease (CKD).
This company performed top during 2013, among biopharmaceutical companies in the US and has two largest dialysis centers in the US, DaVita (DVA) and Fresenius (FMS), as the buyer of its products.
Triferic: Triferic was approved by United States Food and Drug Administration (FDA) in January 2015. Triferic is the only FDA-approved therapy indicated to replace iron and maintain hemoglobin in adult hemodialysis patients with chronic kidney disease. Triferic replaces the iron lost during hemodialysis treatments. Triferic delivers iron directly to transferrin which transported it to the bone marrow to make hemoglobin. Rockwell is actively marketing and commercializing Triferic in the U.S. hemodialysis market.
Calcitriol: Calcitriol (active vitamin D) generic is FDA approved for treating secondary hyperparathyroidism or hypocalcemia in hemodialysis patients.
Hemodialysis Concentrates: Rockwell is an established manufacturer of hemodialysis concentrates/dialysates for dialysis providers and distributors in the U.S. and globally. Hemodialysis concentrates remove toxins and replace critical nutrients in the dialysis patient’s bloodstream during hemodialysis. Rockwell has three U.S. manufacturing and distribution facilities.
One of the main treatment that the company develops is for iron supplementation, a key element in the formation of new red blood cells. The product is called soluble ferric pyrophosphate (SFP), and its therapy was licensed in 2011 for the delivery of iron supplementation for patients who suffer from anemic dialysis, since the process accounts for treatment in around 90 percent of anemia patients. The clinical experiment for this treatment is under Phase III during 2011.
In February 2014, the Company completed its large-scale, long-term safety study for iron maintenance drug Triferic.
In December 2011, Rockwell Medical Inc. acquired an abbreviated new drug application (ANDA), which is used for calcitriol, an intravenous Vitamin D analogue, in a gene-related version.