MELBOURNE, Australia,
Sept. 26 /PRNewswire-FirstCall/ --
Hospira, Inc. (NYSE: HSP), the world leader in generic injectable
pharmaceuticals, today announced that it has received Australian
Therapeutic Goods Administration (TGA) approval for its biosimilar
filgrastim product, Nivestim™.
Nivestim has been approved for a range of indications, including
the prevention of febrile neutropenia (FN) and reduction in
duration of chemotherapy-induced neutropenia (CIN). Neutropenia is
the most serious hematological toxicity that occurs as a result of
cancer chemotherapy and can lead to chemotherapy dose reductions
and/or dose delays compared with the prescribed schedule.(1)
Nivestim is the first biosimilar version of Neupogen® approved
in Australia. Neupogen has current
sales within Australia of
approximately AUD25 million (U.S. $24
million). Hospira is working closely with Australian
government agencies to ensure efficient market access for
biosimilars, and has submitted an application to have Nivestim
listed on the Australian Pharmaceutical Benefits Scheme. Listing
and product launch are expected during the first half of 2011.
"Approval of Nivestim, the first biosimilar filgrastim in
Australia, is another important
milestone for Hospira as we build our global biosimilars
portfolio," said Tim Oldham,
president, Asia Pacific, Hospira.
"Nivestim will help reduce the cost of providing this lifesaving
therapy across Australia, and
includes a unique combination of administration, storage and safety
features that will enhance safety for healthcare professionals and
patients."
Three pre-filled syringe presentations of Nivestim were approved
in Australia: 300 mcg/0.5 mL, 480
mcg/0.5 mL and a unique 120 mcg/0.2 mL low body weight
presentation.
In a large, randomized Phase lll study, Nivestim demonstrated
comparable efficacy to Neupogen in the prevention of FN, and was as
well tolerated, with a similar adverse event profile.(2)
Nivestim is Hospira's second biosimilar and first in
Australia. The company's
biosimilar erythropoietin, Retacrit™, is currently available in 17
European countries, and Nivestim was approved by the European
Commission in June 2010.
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. The
head office for Hospira in the Asia
Pacific region is in Melbourne,
Australia. 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 regarding Hospira's goals with respect
to Nivestim. 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.
(1) Crawford J, Dale DC, Lyman GH. Chemotherapy-Induced
Neutropenia: Risks, Consequences, and New Directions for Its
Management. Cancer, 2004; 100(2): 228-37
(2) Waller, CF et al. Biosimilar filgrastim is an effective
primary prophylactic therapy for neutropenia in patients (pts)
receiving doxorubicin and docetaxel (AT) for breast cancer (BC).
Poster presentation at the joint ECCO 15 and 34th ESMO
Multidisciplinary Congress: Abstract E15-1238, 2009.
SOURCE Hospira, Inc.
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