LAKE FOREST, Ill., July 26 /PRNewswire-FirstCall/ -- 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.
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 13,500 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
and other statements regarding Hospira's goals and strategy.
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,
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 filed
with the Securities and Exchange Commission and subsequently filed
Quarterly Reports on Form 10-Q, 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.