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Hospira Announces Positive Results From Phase I U.S. Clinical Trial of Biosimilar Erythropoietin in Renal Patients
Date:9/6/2011

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™, 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™, 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
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SOURCE Hospira, Inc.
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