Rockwell Medical's iron deficiency drug succeeds in final study
(Reuters) - Rockwell Medical Inc said its lead experimental drug met the main goal of improving hemoglobin levels in its final late-stage trial among adult patients with chronic kidney disease.
Rockwell shares rose 14 percent to $6.34 in heavy trading on the Nasdaq.
The study was the second of two identical late-stage studies testing the drug in patients with chronic kidney disease on hemodialysis — a process by which waste and extra fluid is removed from the blood of patients with kidney failure.
Summer Street Research analyst Carol Werther said the company would be able to file for marketing approval in four to six months and that the drug, Soluble Ferric Pyrophosphate, was likely to be approved in the second half of 2014.
Werther said the drug could generate annual sales of $225 million in 2017.
SFP is administered via the fluid used in dialysis, and is intended to replace the standard intravenous iron therapy for patients with chronic kidney disease, which can cause allergic reactions.
Summer Street's Werther said the drug's unique method of administration allowed the maintenance of hemoglobin levels and lowered the risk of iron overload in dialysis patients, which could increase infection rates.
The company reported positive results from the first study of SFP in July.
A separate study in February showed that regular treatment with the drug reduced the need for erythropoietin-stimulating agents, which are expensive medications that stimulate the production of red blood cells.
Rockwell said there was no difference in the frequency or severity of adverse events between patients taking the drug and those on the placebo.
Chief Executive Rob Chioini said he had great confidence in getting approval from the U.S. Food and Drug Administration for the drug and that SFP could become the new standard of care in iron therapy.
SFP is also being tested in early-stage trials as an oral drug and for delivery through peritoneal dialysis and total parenteral nutrition.
(Reporting By Vrinda Manocha in Bangalore; Editing by Joyjeet Das, Maju Samuel)