Wednesday, September 4, 2013

Reuters: Hot Stocks: UPDATE 1-Rockwell Medical's iron deficiency drug succeeds in second late-stage study

Reuters: Hot Stocks
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UPDATE 1-Rockwell Medical's iron deficiency drug succeeds in second late-stage study
Sep 4th 2013, 12:14

Wed Sep 4, 2013 8:14am EDT

* Drug shows similar safety profile compared with placebo

* Shares up 14 pct in premarket trading (Adds details, background)

Sept 4 (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.

Shares of the company rose 14 percent to $6.30 in trading before the bell.

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.

The company reported positive results from the first study of the drug, Soluble Ferric Pyrophosphate (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 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. (Reporting By Vrinda Manocha in Bangalore; Editing by Joyjeet Das)

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