Hospira Announces Positive Results From Phase I U.S. Clinical Trial of Biosimilar Erythropoietin(EPO) in Renal Patients
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 begin this year, will be a larger study also involving renal patients. Hospira is consulting with the U.S. Food and Drug Administration (FDA) to plan the trial, which will take place at U.S. hemodialysis centers.
Hospira already sells a biosimilar EPO in Europe, Retacrit(TM), and is the first and only North American-headquartered company with biosimilars on the European market. Retacrit, introduced in early 2008, now has a more than 50 percent share of the total short-acting EPO biosimilar market in Europe. In addition, Hospira launched Nivestim(TM), a biosimilar version of filgrastim, in Europe in 2010 and in Australia earlier this year. Filgrastim is a granulocyte colony-stimulating factor (G-CSF) used to treat neutropenia, a condition in which the body makes too few infection-fighting white blood cells. The condition is often caused by drugs prescribed for cancer treatment.
Hospira’s Phase I study was conducted with the participation of DaVita Inc. (NYSE: DVA) and Fresenius Medical Care AG & Co. KGaA (NYSE: FMS, FMS/P). Although Phase I trials are most often conducted with healthy volunteers, Hospira received FDA approval to conduct its Phase I trial with renal patients.
Biosimilars are high-quality, cost-effective alternatives to proprietary biopharmaceuticals, which are large-protein molecules derived from genetically modified cell lines. In contrast, “traditional” pharmaceuticals are made from small-molecule, chemical substances. With a growing number of patents for biopharmaceuticals expiring in the United States and around the globe, Hospira has significantly expanded its comprehensive competencies to develop, manufacture and market biosimilars, and has one of the largest biosimilar pipelines in the industry. Hospira’s entrance into the biosimilar pharmaceutical market is a natural extension of its leading global generic injectable pharmaceuticals business.
