- Data from more than 2,300 patients in large post-marketing,
observational ORHEO study is now available online
LEAMINGTON SPA, England,
July 24, 2014 /PRNewswire/ -- Hospira
(NYSE: HSP), the world's leading provider of injectable drugs and
infusion technologies, announced today that the results from the
ORHEO study (place of biOsimilaRs in the therapeutic management of
anemia secondary to chemotherapy in HaEmatology and Oncology) have
been published in BMC Cancer, and show that the company's European
biosimilar epoetin, Retacrit™ (epoetin zeta) was effective and well
tolerated in the management of chemotherapy-induced anemia in
patients with solid tumors, lymphoma and myeloma.1
The ORHEO study, conducted in France to treat oncology patients suffering
from chemotherapy-induced anemia due to malignancy, was a
prospective, observational study in which 2,310 adult patients
(99.9 percent receiving epoetin zeta) were evaluated with
chemotherapy-induced anemia and solid tumors, lymphomas or
myelomas. The primary endpoint was the rate of response (defined as
an increase in haemoglobin (Hb) levels to at least 10 g/dL since
inclusion visit; if there had been an increase in Hb levels of at
least 1 g/dL since the inclusion visit; reaching target Hb levels
set at start of study, without any blood transfusions in the three
weeks prior to measurement) at plus three months.1 The
ORHEO study demonstrated that more than 80 percent of patients
receiving Retacrit achieved a pre-defined Hb response in a
real-world clinical setting, and that this was maintained at month
six.1 Of the patients in the study, 17.1 percent
experienced an adverse event (AE), in line with rates typically
seen for the reference product. Retacrit was well tolerated in this
study, with an overall rate of thrombotic events at 3.5 percent. In
this observational study, no epoetin zeta-related deaths were
reported.
"Biosimilars have an important role to play in the future of
medicine, and because they are more cost effective than their
reference products, it is estimated they will save European
healthcare systems between €11.8 bn and €33.4 bn between 2007 and
20202," said Stan
Bukofzer, Corporate Vice President and Chief Medical
Officer, Hospira. "The ORHEO study provides important information
on how Retacrit is benefiting patients in the clinic, and helps to
demonstrate the potential of biosimilar epoetins to benefit
patients while reducing healthcare costs."
In addition to the main study, a post-hoc sub-analysis of data
from the ORHEO study has shown that Retacrit was effective and well
tolerated in elderly people, with patients aged 70 years and over
having comparable experiences to younger patients.3 The
sub-analysis was presented last month at the International
Symposium on Supportive Care in Cancer 2014, a joint meeting of the
Multinational Association of Supportive Care in Cancer (MASCC) and
the International Society of Oral Oncology (ISOO), held in
Miami, USA.
Retacrit (epoetin zeta) was approved in Europe in 2007 as a biosimilar medicine to the
reference biological product, epoetin alfa. Retacrit is an
erythropoiesis-stimulating agent, which is intended to correct and
maintain red blood cell counts. Retacrit is used to:
- treat anaemia (low red-blood-cell counts) that is causing
symptoms in patients with chronic renal failure (long-term,
progressive decrease in the ability of the kidneys to work
properly) or other kidney problems;
- treat anaemia in adults receiving chemotherapy to treat certain
types of cancer and to reduce the need for blood transfusions;
- increase the amount of blood that patients with moderate
anaemia can self-donate before surgery, so that their own blood can
be given back to them during or after surgery;
- reduce the need for blood transfusions in patients with
moderate anaemia about to undergo major bone surgery (such as a hip
or knee replacement).
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
Leamington Spa, UK.
Private Securities Litigation Reform Act of
1995 –
A Caution Concerning Forward-Looking
Statements
This press release contains, or may contain, 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 other 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, are incorporated by reference.
Hospira undertakes no obligation to release publicly any revisions
to forward-looking statements as a result of subsequent events or
developments, except as required by law.
1 Michallet M, Luporsi E, Soubeyran P, et al.
BiOsimilaRs in the management of anaemia secondary to chemotherapy
in HaEmatology and Oncology: results of the ORHEO observational
study. BMC Cancer 2014; 14:503 (July
10, 2014);
http://www.biomedcentral.com/1471-2407/14/503/abstract.
2 Haustein R, Millas C, Höer A, et al. Saving
money in the European healthcare systems with biosimilars.
Generics and Biosimilars Initiative Journal.
2012;1(3-4):120-6.
3 Soubeyran P, Kurtz JE, Michallet M, et al.
Biosimilar epoetin for the management of chemotherapy-induced
anaemia in elderly patients: a subanalysis of the ORHEO study.
Presented at the MASCC 2014 Symposium, 26-28
June 2014. Abstract available at
http://mascc2014.meetingxpert.net/mascc_595/poster_97015/program.aspx/97015
[last accessed 23rd July 2014].