Hospira, Inc. announced positive results from a Phase I clinical trial of its biosimilar erythropoietin in patients with renal 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.
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 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 begin this year, will be a larger study also involving renal patients. Hospira already sells a biosimilar EPO in Europe. Retacrit, introduced in early 2008, now has a more than 50% share of the total short-acting EPO biosimilar market in Europe, according to the company.
Hospira''s Phase I study was conducted with the participation of DaVita Inc. and Fresenius Medical Care AG & Co. KGaA.