Magazin

2010-02-22

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


London, February 22, 2010 (ots/PRNewswire) - Hospira announced todaythat 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. Thisprovides an alternative option to intravenous (IV) delivery of thedrug for the symptomatic treatment of anaemia associated with chronicrenal failure. Final approval by the European Commission (EC) isexpected in the next few months, which will result in marketingauthorisation for Retacrit subcutaneous (SC) administration in all EUmember states.

"As part of Hospira's continued commitment to expand biosimilaroptions for patients, we are pleased that Retacrit is the firstbiosimilar epoetin to get a recommendation from the CHMP forsubcutaneous administration in the nephrology setting," said MichaelKotsanis, Hospira's President of Europe, Middle East and Africa."Once approved by the European Commission, Retacrit will be suitablefor subcutaneous as well as intravenous administration in thenephrology setting. This will give clinicians greater flexibility inmanaging symptomatic anaemia in their renal patients and providehealthcare professionals with a cost-effective alternative tooriginator epoetins."

The recommendation for approval of Retacrit SC administrationfollows the submission of data from a rigorous Phase III clinicaltrial demonstrating comparable efficacy and safety between epoetinzeta and the reference product, epoetin alfa, when administeredsubcutaneously in patients with end-stage renal failure on chronichaemodialysis.

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 withRetacrit at home. Many will also be able to self-inject Retacrit forthe first time. For several reasons, subcutaneous administration canconserve hospital resources and save valuable time for patients,too."

The approval has the potential to benefit both healthcare systemsand patients across the EU. Cost savings can be made when chronicallyill patients learn to self-administer their medication, because theyno longer need a visit from (or to) a healthcare professional.

Notes to Editors:

About Retacrit

Retacrit (epoetin zeta) is a biosimilar EPO indicated for thetreatment of chemotherapy-induced anaemia, and anaemia associatedwith chronic renal failure. It is currently licensed for IVadministration in nephrology and via the SC route in the oncologysetting. SC administration in the nephrology setting has received apositive opinion in Europe, with approval expected in the first halfof 2010.

Retacrit(TM) is a trademark of Hospira.

About biosimilars

The introduction of biosimilars such as Retacrit can help providea more cost-effective option than originator brands and thereby helpto reduce healthcare costs in the EU. It has been estimated thatbiosimilar competition resulting in a 20 percent price reduction infive off-patent biopharmaceuticals could save the EU over EUR1.6billion per year.(1)

About Hospira

Hospira is a global specialty pharmaceutical and medicationdelivery company dedicated to Advancing Wellness(TM). As the worldleader in specialty generic injectable pharmaceuticals, Hospiraoffers one of the broadest portfolios of generic acute-care andoncology injectables, as well as integrated infusion therapy andmedication management solutions. Through its products, Hospira helpsimprove the safety, cost and productivity of patient care. Thecompany is headquartered in Lake Forest, Illinois, United States andhas approximately 13,500 employees. The head office for Hospira inEurope, Middle East and Africa is in Leamington Spa, UK. Learn moreat http://www.hospira.com.

Private Securities Litigation Reform Act of 1995 - A CautionConcerning Forward-Looking Statements

This press release contains forward-looking statements within themeaning of the Private Securities Litigation Reform Act of 1995,including statements regarding certain regulatory approvals andstatements regarding Retacrit. Hospira cautions that theseforward-looking statements are subject to risks and uncertaintiesthat may cause actual results to differ materially from thoseindicated in the forward-looking statements. Economic, competitive,governmental, legal, technological and other factors that may affectHospira's operations and may cause actual results to be materiallydifferent from expectations include the risks, uncertainties andfactors discussed under the headings "Risk Factors" and "Management'sDiscussion and Analysis of Financial Condition and Results ofOperations" in Hospira's latest Annual Report on Form 10-K andsubsequent Forms 10-Q, filed with the Securities and ExchangeCommission, which are incorporated by reference. Hospira undertakesno obligation to release publicly any revisions to forward-lookingstatements as the result of subsequent events or developments.

References:

1. European Generic Medicines Association. EGA Handbook onBiosimilar Medicines 2007

ots Originaltext: Hospira, Inc.Im Internet recherchierbar: http://www.presseportal.de

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.

Hospira, Inc.

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