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Hospira Begins Phase I U.S. Clinical Trial of Biosimilar Erythropoietin in Renal Patients
Date:7/26/2010

LAKE FOREST, Ill., July 26 /PRNewswire-FirstCall/ -- Hospira, Inc. (NYSE: HSP), the world leader in generic injectable pharmaceuticals, today announced the start of a U.S. Phase I clinical trial of its biosimilar erythropoietin (EPO) in patients with renal (kidney) dysfunction who have anemia, an important step on the road toward introducing a biosimilar product in the United States. Erythropoietin is a treatment for anemia associated with chronic renal failure and chemotherapy.

The controlled, randomized trial of patients on hemodialysis who have already been treated with Amgen's Epogen® (epoetin alfa), is taking place at 20 different hemodialysis centers across the United States. Patients in the trial will be treated with both Epogen and Hospira's EPO, with each patient receiving one drug first and then being switched to the second drug. The goal of the Phase I trial is to test safety and pharmacokinetics, or measurements of the drug's blood level and distribution in the body, compared with the reference product. Pending successful completion of the Phase I trial, Hospira would launch an expanded Phase III trial in 2011, also comparing safety and efficacy of Hospira's EPO with Epogen.

"This trial marks a key milestone for Hospira's biosimilars program," said Sumant Ramachandra, M.D., Ph.D., senior vice president, Research & Development and Medical & Regulatory Affairs, and chief scientific officer, Hospira. "Congressional approval of a regulatory pathway for biosimilar drugs in the U.S. set the stage for our development of a U.S. biosimilar EPO. We hope to leverage our leadership in generics and our biosimilars experience in '/>"/>

SOURCE Hospira, Inc.
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