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Hospira Announces Start of U.S. Phase III Biosimilar EPO Clinical Program

LAKE FOREST, Ill., Jan. 9, 2012 /PRNewswire/ -- Hospira, Inc. (NYSE: HSP), the world's leading provider of injectable drugs and infusion technologies, today announced enrollment of the first patient in a Phase III U.S. clinical program for its biosimilar erythropoietin (EPO). Hospira's Phase III program, which follows a successful Phase I trial that concluded last year, will compare safety and efficacy of Hospira's EPO and the reference product, Amgen's Epogen® in patients with renal (kidney) dysfunction who have anemia. Erythropoietin is a treatment for anemia associated with chronic renal failure.

The program will enroll approximately 1,000 patients on hemodialysis who have already been treated with Epogen, and will take place at more than 200 different hemodialysis centers across the United States. Results are expected in 2013.

"Patient enrollment in our Phase III EPO program is another important step as Hospira prepares to introduce safe, effective and affordable biosimilars in the United States,"  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 offering U.S. patients access to these important medications."

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 and in Australia. Retacrit was introduced in early 2008, and Hospira launched Nivestim, a biosimilar version of filgrastim, in Europe in 2010 and in Australia last 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 III program is being conducted with the participation of DaVita Inc. (NYSE: DVA) and Fresenius Medical Care (NYSE: FMS), as well as many dialysis clinics and hospitals across the United States.

Further details about Hospira's Phase III program can be accessed at the following two links:

Hospira's Phase I U.S. EPO trial met its key endpoint, showing equivalent pharmacokinetics, or blood level and distribution in the body, for Hospira's EPO and Epogen.

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 participation in the biosimilar pharmaceutical market is a natural extension of its leading global generic injectable pharmaceuticals business.

About Hospira

Hospira, Inc. is the world's leading provider of injectable drugs and infusion technologies. Through its broad, integrated portfolio, Hospira is uniquely positioned to Advance Wellness™ by improving patient and caregiver safety while reducing healthcare costs. The company is headquartered in Lake Forest, Ill., and has approximately 14,000 employees. Learn more at

Private Securities Litigation Reform Act of 1995 -- A Caution Concerning Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to Hospira's biosimilars program. Hospira cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Economic, competitive, governmental, regulatory, legal, technological, manufacturing supply, quality and other factors that may affect Hospira's operations and may cause actual results to be materially different from expectations include the risks, uncertainties and factors discussed under the headings "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Hospira's latest Annual Report on Form 10-K and subsequent Forms 10-Q, filed with the Securities and Exchange Commission, which are incorporated by reference. Hospira undertakes no obligation to release publicly any revisions to forward-looking statements as the result of subsequent events or developments.

SOURCE Hospira, Inc.
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