LAKE FOREST, Ill., Sept. 6, 2011 /PRNewswire/ — Hospira, Inc. (NYSE:
HSP), the world leader in generic injectable pharmaceuticals,
today announced positive results from a Phase I U.S. clinical trial
of its biosimilar erythropoietin (EPO) in patients with renal
(kidney) dysfunction who have anemia. Hospira’s trial met its key
endpoint, showing equal pharmacokinetics, or blood level and
distribution in the body, for Hospira’s EPO and the reference
product, Amgen’s Epogen®. Erythropoietin is a treatment for
anemia associated with chronic renal failure and chemotherapy.
The controlled, randomized trial of 100 patients on hemodialysis
who had already been treated with Epogen took place at 20 different
hemodialysis centers across the United States. Patients in the
trial were treated with both Epogen and Hospira’s EPO, with each
patient receiving one drug first and then being switched to the
second drug, spending one week on each. Besides showing equivalent
pharmacokinetics, the trial showed no difference in patient safety
between the two drugs, a secondary endpoint. The positive Phase I
results pave the way for Hospira’s planned Phase III U.S. program
comparing safety and efficacy of the two products.
“The successful completion of our Phase I EPO trial is an
important step for Hospira’s U.S. biosimilars program,” said Sumant
Ramachandra, M.D., Ph.D., senior vice president, Research &
Development and Medical & Regulatory Affairs, and chief
scientific officer, Hospira. “We look forward to starting
our Phase III U.S. program, and are committed to building on our
success with biosimilars in Europe and Australia by making
affordable, safe and effective biosimilars available to U.S.
patients and their healthcare providers once patents expire over
the next several years.”
The first Phase III U.S. trial, scheduled to
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