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:
http://clinicaltrials.gov/ct2/show/NCT01473407?term=epogen%2C+hospira&rank=1
http://clinicaltrials.gov/ct2/show/NCT01473420?term=epogen%2C+hospira&rank=2
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 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, 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.