HURLEY, United Kingdom,
April 28, 2014 /PRNewswire/ --
Hospira (NYSE: HSP), the world's leading provider of injectable
drugs and infusion technologies, last week shared results from a
post-authorization observational safety study, conducted in
clinical sites in Europe, of
biosimilar epoetin product Retacrit™/Silapo® (epoetin
zeta) in patients with renal anaemia. The study's results,
presented at the National Kidney Foundation 2014 Spring Clinical
Meetings, exhibited a safety pattern for Retacrit/Silapo comparable
with known data for other epoetin alfa products. Retacrit is
marketed in Europe by Hospira, and
Silapo is marketed in Germany by
cell pharm GmbH, a 100% subsidiary of STADA Arzneimittel AG.
Retacrit and Silapo are manufactured by STADA Arzneimittel AG.
The study, PASCO I (post-authorization safety cohort
observational study), included anaemic patients with chronic kidney
disease receiving haemodialysis and who were treated with
Retacrit/Silapo administered intravenously for up to one year.
Hospira conducted the study in conjunction with STADA Arzneimittel
AG as part of the risk-management plan (RMP) post-approval
commitment to the European Medicines Agency (EMA), and included
safety data from more than 1,600 patients in four European
countries. Approximately 94 percent of patients were treated
previously with an erythropoiesis stimulating agent (ESA). The
primary objective of PASCO I was to determine the incidence of
adverse events of special interest (AESI) in patients being treated
with Retacrit/Silapo for renal anaemia. The full abstract can be
found here.
In the patients studied, treatment of renal anaemia with
Retacrit/Silapo was found to have a safety profile consistent with
that found in the Retacrit/Silapo registration trials with the same
route of administration and in line with other ESAs.
"Importantly, this study showed a safety profile consistent with
what was found in registration trials for Hospira and STADA's
product," said Paul Audhya, M.D.,
vice president, Medical Affairs, Hospira. "Since their introduction
in Europe, biosimilar medications
have increased treatment options and improved patient access to
biologic medications, including ESAs."
Frank Dellanna, M.D., of MVZ DaVita Karlstrasse, Düsseldorf,
Germany, said, "This study
contributes to current knowledge about the frequency of adverse
events associated with the use of Retacrit/Silapo for the treatment
of renal anaemia."
Hospira and STADA Arzneimittel AG are currently conducting an
additional post-authorization observational safety study (PASCO II)
intended to further the safety profile of Retacrit/Silapo given
subcutaneously over a period of three years in 6,700 European
patients being treated for anaemia associated with renal disease.
As with PASCO I, this study is also being conducted as part of an
RMP commitment to EMA for further pharmacovigilance
surveillance.
Hospira has many years of experience in the field of biologics
and one of the largest biosimilar pipelines in the industry. It is
the only North American-based company with biosimilars on the
European market, including Retacrit (epoetin zeta) which was
launched in Europe in early 2008
and Nivestim™ (filgrastim), which entered the European market in
2010 and the Australian market in 2011. Hospira's first biosimilar
monoclonal antibody (mAb), Inflectra™ (infliximab), received
European approval in 2013 and is being introduced in select
European markets.
About Hospira
Hospira, Inc. is the world's leading
provider of injectable drugs and infusion technologies, and a
global leader in biosimilars. 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
17,000 employees. Learn more at www.hospira.com.
The head office for Hospira in Europe, Middle
East and Africa is in
Hurley, UK.
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 regarding Hospira's biosimilars program
and study results related to Retacrit. Hospira cautions that these
forward-looking statements are subject to risks and uncertainties,
including adequate and sustained progress on the company's quality
initiatives and device strategy 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, modernizing and
streamlining activities, 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.