Hospira Receives TGA Approval for Nivestim, Australia's First Biosimilar Filgrastim
-- Launch of Product Expected in First Half of 2011 --
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.
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.
Posted: September 2010