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™, 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 business.
About Hospira
Hospira, Inc. is a global specialty pharmaceutical and
medication delivery company dedicated to Advancing Wellness™. 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.
SOURCE Hospira, Inc.