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Hospira Data on European Biosimilar Epoetin, Retacrit, Affirm Treatment Response, Tolerability in Management of Anemia Secondary



   Hospira Data on European Biosimilar Epoetin, Retacrit, Affirm Treatment
   Response, Tolerability in Management of Anemia Secondary to Chemotherapy

  PR Newswire

  LAKE FOREST, Illinois, June 3, 2013

-- Post-marketing study, presented at ASCO, included more than 2,300 patients
--

LAKE FOREST, Illinois, June 3, 2013 /PRNewswire/ -- Hospira, Inc. (NYSE: HSP),
the world's leading provider of injectable drugs and infusion technologies,
announced today results from a post-marketing study of the company's European
biosimilar epoetin, Retacrit™. This prospective, observational study met the
primary endpoint, as defined by hemoglobin treatment response, in the
management of chemotherapy-induced anemia in adult patients with solid tumors,
lymphomas and myelomas, regardless of chemotherapy cycle. Retacrit was well
tolerated by patients in the study. Full results of the study, called ORHEO
(place of biOsimilaRs in the therapeutic management of anemia secondary to
chemotherapy in HEmatology and Oncology), were presented at the 48 ^th Annual
Meeting of the American Society of Clinical Oncology (ASCO) on June 3
(Abstract 9564).

Retacrit, a recombinant human erythropoietin, or an "EPO biosimilar," was
launched in Europe in early 2008. Retacrit is used to treat symptomatic anemia
associated with chronic renal failure in adult and pediatric patients and
anemia in adult patients receiving chemotherapy for solid tumors, malignant
lymphoma or multiple myeloma.

Study Design

Patients with chemotherapy-induced anemia (Hb

Study Results

This European prospective, observational study included 2,310 patients with
solid tumors, lymphomas or myelomas. The majority of patients (>80 percent)
enrolled in this study achieved a pre-defined hemoglobin (Hb) response with
Retacrit in a real-world clinical setting. Retacrit was well tolerated in this
study with an overall rate of thrombotic events at 3.5 percent. In this
observational study, no epoetin alfa biosimilar-related deaths were reported.
^[1]

View 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; Epoetin
biosimilars in the management of anemia secondary to chemotherapy in patients
with solid tumors, lymphomas, and myelomas: The ORHEO study; Poster session
presented at 2013 ASCO Annual Meeting

"Patients in the study showed a very good rate of response to Retacrit and
tolerated 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 a
biosimilar, and the results reinforce why there is a growing acceptance of
biosimilars. The introduction of biosimilars has offered new options for
patients 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:

  * 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
  * 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
  * 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 Meeting

Hospira's second marketed biosimilar product is Nivestim™, a biosimilar
version of filgrastim, a recombinant Granulocyte Colony-Stimulating Factor
(G-CSF), used for a condition known as neutropenia in which the body makes too
few infection-fighting white blood cells. Nivestim entered the European market
in 2010 and the Australian market in 2011.

Hospira's broad biosimilars pipeline, including products it shares with South
Korean partner Celltrion, is comprised of 11 products and is one of the
largest in the industry. In 2012, Hospira filed for European approval of a
biosimilar version of infliximab, a treatment for auto-immune diseases,
including rheumatoid arthritis, Crohn's disease, ulcerative colitis and
psoriasis. 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 for
its U.S. epoetin product, which is being developed as a biosimilar to
erythropoietin alpha in patients with renal (kidney) dysfunction who have
anemia.

About Hospira

Hospira, Inc. is the world's leading provider of injectable drugs and infusion
technologies. Through its broad, integrated portfolio, Hospira is uniquely
positioned to Advance Wellness™ by improving patient and caregiver safety
while reducing healthcare costs. The company is headquartered in Lake Forest,
Ill., and has approximately 16,000 employees. Learn more at www.hospira.com .

^[1] Elisabeth Luporsi-Gely, Pierre-Louis Soubeyran, Mauricette Michallet;
Centre Alexis Vautrin, Nancy, France; Institut Bergonie, Bordeaux, France;
Centre Hospitalier Lyon Sud, Pierre Bénite, France; Epoetin biosimilars in the
management of anemia secondary to chemotherapy in patients with solid tumors,
lymphomas, and myelomas: The ORHEO study; Poster session presented at 2013
ASCO Annual Meeting

Website: http://www.hospira.com
Contact: Media, Dan Rosenberg, +1-224-212-3366, or Financial Community, Ruth
Venning, +1-224-212-2711, or Karen King, +1-224-212-2711
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