Hospira Announces Positive Results From Phase I U.S. Clinical Trial of Biosimilar Erythropoietin in Renal Patients
First Phase III U.S. trial to begin later this year --
LAKE FOREST, Ill., Sept. 6, 2011 /PRNewswire via COMTEX/ --
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.
Hospira, Inc. is a global specialty pharmaceutical and medication delivery company dedicated to Advancing Wellness(TM). As the world leader in specialty generic injectable pharmaceuticals, Hospira offers one of the broadest portfolios of generic acute-care and oncology injectables, as well as integrated infusion therapy and medication management solutions. Through its products, Hospira helps improve the safety, cost and productivity of patient care. The company is headquartered in Lake Forest, Ill., and has approximately 14,000 employees. Learn more at www.hospira.com.
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 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.