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Hospira, Inc.

Retacrit(TM) to be the 1st Biosimilar Epoetin to Achieve Subcutaneous Licence in Renal Patients

London, February 22, 2010 (ots/PRNewswire)

Hospira announced today
that the European Committee for Medicinal Products for Human Use
(CHMP) has recommended for approval the administration of Retacrit
(epoetin zeta) subcutaneously in the nephrology setting. This
provides an alternative option to intravenous (IV) delivery of the
drug for the symptomatic treatment of anaemia associated with chronic
renal failure. Final approval by the European Commission (EC) is
expected in the next few months, which will result in marketing
authorisation for Retacrit subcutaneous (SC) administration in all EU
member states.
"As part of Hospira's continued commitment to expand biosimilar
options for patients, we are pleased that Retacrit is the first
biosimilar epoetin to get a recommendation from the CHMP for
subcutaneous administration in the nephrology setting," said Michael
Kotsanis, Hospira's President of Europe, Middle East and Africa.
"Once approved by the European Commission, Retacrit will be suitable
for subcutaneous as well as intravenous administration in the
nephrology setting. This will give clinicians greater flexibility in
managing symptomatic anaemia in their renal patients and provide
healthcare professionals with a cost-effective alternative to
originator epoetins."
The recommendation for approval of Retacrit SC administration
follows the submission of data from a rigorous Phase III clinical
trial demonstrating comparable efficacy and safety between epoetin
zeta and the reference product, epoetin alfa, when administered
subcutaneously in patients with end-stage renal failure on chronic
haemodialysis.
Kees Groenhout MD, Vice President of Global Clinical R & D,
Hospira, said: "The approval will be a significant step forward,
because patients who aren't yet on haemodialysis can be treated with
Retacrit at home. Many will also be able to self-inject Retacrit for
the first time. For several reasons, subcutaneous administration can
conserve hospital resources and save valuable time for patients,
too."
The approval has the potential to benefit both healthcare systems
and patients across the EU. Cost savings can be made when chronically
ill patients learn to self-administer their medication, because they
no longer need a visit from (or to) a healthcare professional.
Notes to Editors:
About Retacrit
Retacrit (epoetin zeta) is a biosimilar EPO indicated for the
treatment of chemotherapy-induced anaemia, and anaemia associated
with chronic renal failure. It is currently licensed for IV
administration in nephrology and via the SC route in the oncology
setting. SC administration in the nephrology setting has received a
positive opinion in Europe, with approval expected in the first half
of 2010.
Retacrit(TM) is a trademark of Hospira.
About biosimilars
The introduction of biosimilars such as Retacrit can help provide
a more cost-effective option than originator brands and thereby help
to reduce healthcare costs in the EU. It has been estimated that
biosimilar competition resulting in a 20 percent price reduction in
five off-patent biopharmaceuticals could save the EU over EUR1.6
billion per year.(1)
About Hospira
Hospira is a global specialty pharmaceutical and medication
delivery company dedicated to Advancing Wellness(TM). 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, Illinois, United States and
has approximately 13,500 employees. The head office for Hospira in
Europe, Middle East and Africa is in Leamington Spa, UK. Learn more
at http://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 regarding certain regulatory approvals and
statements regarding Retacrit. 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 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.
References:
1. European Generic Medicines Association. EGA Handbook on
Biosimilar Medicines 2007

Contact:

CONTACT: For further information please contact: Media, Hannah
Stacey,Athena, +44(0)20-8956-2289 or +44(0)7984-496-441; Financial
Community,Karen King, +1-224-212-2711.

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