Navigation Links
Hospira Data on European Biosimilar Epoetin, Retacrit, Affirm Treatment Response, Tolerability in Management of Anemia Secondary to Chemotherapy
Date:6/3/2013

LAKE FOREST, Ill., 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 48th 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 <110 g/L), greater than 18 years old, with solid tumors, lymphomas or myelomas and eligible for epoetin alfa treatment were included in the study. The primary endpoint was the rate of response (defined as an increase in Hb levels to 100 g/L or at least 10 g/L since inclusion visit, or reaching target Hb set at start of study, without any blood transfusions in the three weeks prior to measurement) at plus three months (M3). Other endpoints included rate of response at plus six months (M6) and safety endpoints.

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:

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


'/>"/>
SOURCE Hospira, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Amgen, Hospira and Sandoz Named Among Top Pharmaceutical Companies with Greatest Biosimilar Drug Potential in United States
2. Hospira dévoile sa stratégie appareil mondiale
3. Hospira enthüllt weltweite Gerätestrategie
4. Hospira revela estrategia global para sus dispositivos
5. Hospira revela estratégia global para dispositivos
6. Hospira Reports First-Quarter 2013 Results
7. Hospira Unveils Global Device Strategy
8. Hospira Names Matthew R. Stober Senior Vice President of Operations
9. Hospira to Host Conference Call for First-Quarter 2013 Results
10. Hospira Announces Executive Changes
11. Hospira Reports Fourth-Quarter and Full-Year 2012 Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/28/2017)... 2017 Research and Markets has announced ... 2014-2025" report to their offering. ... The global digestive enzyme ... 2025. Growing consumer awareness regarding the severity of digestive disorders ... stimulate industry growth over the forecast period. The increasing incidence ...
(Date:2/28/2017)... , Feb 28, 2017 ... Research and Markets has ... report to their offering. The global orthobiologics ... The orthobiologics market is predominantly driven by the ... innovations in biomaterials, used in the production of orthobiologics are presumed ...
(Date:2/27/2017)... Health, Inc. (NYSE: HYH ) today reported fourth ... and related key planning assumptions. Executive Summary 2016 ... increase compared to the prior year. Net ... to net income of $15 million in the fourth quarter ... compared to adjusted net income of $27 million in the ...
Breaking Medicine Technology:
(Date:2/27/2017)... ... 27, 2017 , ... It’s no secret that aging causes ... a host of health issues, including urinary incontinence. However, results published in late ... good overall muscle strength in older women, particularly in the abdominal and pelvic ...
(Date:2/27/2017)... ... February 27, 2017 , ... Much attention has been paid to the problem ... on opioid painkillers has fallen short. From 1999 until 2010, fatal overdoses from prescription ... fatal overdoses in male populations.(1) , The proportion of women using illicit drugs is ...
(Date:2/27/2017)... ... February 27, 2017 , ... This ... laser diffraction analysis as a tool to characterize particle size distributions in the ... obtain improved results and novel scientific findings. It describes methods of optimized and ...
(Date:2/27/2017)... (PRWEB) , ... February 27, 2017 , ... ... rehabilitation and alcohol treatment programs in British Columbia, Canada, at https://www.sunshinecoasthealthcentre.ca/ , ... its team. The new hire, Mackenzie Alsager, showcases the Centre's commitment to innovation ...
(Date:2/26/2017)... ... February 25, 2017 , ... The February 13, 2017, assassination of Kim ... over nerve agents and the deadly use of chemical weapons. Many questions exist about ... even small doses can be lethal. , Jay Jagannathan, M.D., of Michigan-based Jagannathan Neurosurgical ...
Breaking Medicine News(10 mins):