UPDATE: Hospira Data on European Biosimilar Epoetin, Retacrit Affirm Treatment Response, Says Study Met Primary Endpoint

Hospira, Inc. (NYSE: HSP), theworld's leading provider of injectable drugs and infusion technologies,announced today results from a post-marketing study of the company's Europeanbiosimilar epoetin, Retacrit™. This prospective, observational study met theprimary endpoint, as defined by hemoglobin treatment response, in themanagement of chemotherapy-induced anemia in adult patients with solid tumors,lymphomas and myelomas, regardless of chemotherapy cycle. Retacrit was welltolerated by patients in the study. Full results of the study, called ORHEO(place of biOsimilaRs in the therapeutic management of anemia secondary tochemotherapy in HEmatology and Oncology), were presented at the 48^th AnnualMeeting of the American Society of Clinical Oncology (ASCO) on June 3(Abstract 9564).Retacrit, a recombinant human erythropoietin, or an "EPO biosimilar," waslaunched in Europe in early 2008. Retacrit is used to treat symptomatic anemiaassociated with chronic renal failure in adult and pediatric patients andanemia in adult patients receiving chemotherapy for solid tumors, malignantlymphoma or multiple myeloma.Study DesignPatients with chemotherapy-induced anemia (Hb <110 10 18 100 g l), greater than yearsold, with solid tumors, lymphomas or myelomas and eligible for epoetin alfatreatment were included in the study. primary endpoint was rate ofresponse (defined as an increase hb levels to l at least lsince inclusion visit, reaching target set start of study, withoutany blood transfusions three weeks prior measurement) plus threemonths (m3). other endpoints response six months (m6)and safety endpoints.study resultsthis european prospective, observational study 2,310 patients withsolid myelomas. majority (>80 percent)enrolled in this study achieved a pre-defined hemoglobin (Hb) response withRetacrit in a real-world clinical setting.   Retacrit was well tolerated inthis study with an overall rate of thrombotic events at 3.5 percent. In thisobservational study, no epoetin alfa biosimilar-related deaths werereported.^1View the full results at: Elisabeth Luporsi-Gely, Pierre-Louis Soubeyran,Mauricette Michallet; Centre Alexis Vautrin, Nancy, France; Institut Bergonie,Bordeaux, France; Centre Hospitalier Lyon Sud, Pierre Bénite, France; Epoetinbiosimilars in the management of anemia secondary to chemotherapy in patientswith solid tumors, lymphomas, and myelomas: The ORHEO study; Poster sessionpresented at 2013 ASCO Annual Meeting"Patients in the study showed a very good rate of response to Retacrit andtolerated it well," said Dr. Elisabeth Luporsi-Gely, of ICL Alexis Vautrin,Vandoeuvre-les-Nancy, France, and one of the study's principal investigators."This is the first post-marketing observation study conducted in France for abiosimilar, and the results reinforce why there is a growing acceptance ofbiosimilars. The introduction of biosimilars has offered new options forpatients and has helped bring cost savings to the healthcare system."In addition to the results from this study, several Hospira-related studies(view links below) were presented at the ASCO Annual Meeting, including: o Young-Hyuck Im, Petro Odarchenko, Daniela Grecea, Dmitry Komov, et al: Double-blind, randomized, parallel group, phase III study to demonstrate equivalent efficacy and comparable safety of CT-P6 and trastuzumab, both in combination with paclitaxel, in patients with metastatic breast cancer (MBC) as first-line treatment; Presented at 2013 ASCO Annual Meeting o Jean-Emmanuel Kurtz, Pierre-Louis Soubeyran, Mauricette Michallet, Elisabeth Luporsi-Gely ;Epoetin biosimilars in the management of chemotherapy-induced anemia in elderly patients: A subanalysis of the ORHEO study; Poster session presented at 2013 ASCO Annual Meeting o Manuel Constenla, Jorge Aparicio, M.Auxiliadora Gomez, Cristina Gravalos Castro, Miriam Lopez-Gomez, Jose Luis Manzano, Maria Dolores Pineda, Juana Maria Cano, Isabel Sevilla,  et al; Tolerability of raltitrexed when it is used in monotherapy and in combination with oxaliplatin (TOMOX) as advanced colorectal cancer treatment in normal clinical practice; Poster session presented at 2013 ASCO Annual MeetingHospira's second marketed biosimilar product is Nivestim™, a biosimilarversion of filgrastim, a recombinant Granulocyte Colony-Stimulating Factor(G-CSF), used for a condition known as neutropenia in which the body makes toofew infection-fighting white blood cells. Nivestim entered the European marketin 2010 and the Australian market in 2011.Hospira's broad biosimilars pipeline, including products it shares with SouthKorean partner Celltrion, is comprised of 11 products and is one of thelargest in the industry. In 2012, Hospira filed for European approval of abiosimilar version of infliximab, a treatment for auto-immune diseases,including rheumatoid arthritis, Crohn's disease, ulcerative colitis andpsoriasis. Hospira also has a biosimilar version of an oncolytic, trastuzumab,in clinical studies.Hospira is currently conducting a Phase III U.S. clinical trial program forits U.S. epoetin product, which is being developed as a biosimilar toerythropoietin alpha in patients with renal (kidney) dysfunction who haveanemia.