Hospira commences EPO Phase I U.S. clinical trial in renal dysfunction patients with anemia

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 Europe to make affordable, safe and effective biosimilars available to U.S. patients and their healthcare providers once patents expire over the next several years."

Hospira already sells a biosimilar EPO in Europe, Retacrit™, and is the first U.S.-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 recently launched Nivestim™, a biosimilar version of filgrastim, in the United Kingdom, Germany and Ireland. 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 is being 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 U.S. Food and Drug Administration (FDA) approval to conduct its Phase I trial with 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, Hospira has significantly expanded its comprehensive competencies to develop, manufacture and market biosimilars, and has one of the largest biosimilar pipelines in the industry.