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:6/24/2016)... June 24, 2016 ... announced the addition of the " Global Markets ... This report focuses ... an updated review, including its applications in various applications. ... market, which includes three main industries: pharmaceutical and biotechnology, ...
(Date:6/24/2016)... and SAN CLEMENTE, Calif. , June 24, ... -based mobile pulmonary function testing company, is now able to perform ... developed by ndd Medical Technologies , Inc. ... in hospital-based labs.  Thanks to ndd,s EasyOne PRO ® , ARL ... can get any needed testing done in the comfort of her ...
(Date:6/24/2016)... , Belgium , June ... MKT: VNRX), today announced the appointment of Dr. ... of Directors as a Non-Executive Director, effective June ... Company,s Audit, Compensation and Nominations and Governance Committees.  ... Dr. Futcher will provide independent expertise and strategic ...
Breaking Medicine Technology:
(Date:6/26/2016)... N.J. (PRWEB) , ... June 27, 2016 , ... Quality ... sources, yet in many ways they remain in the eye of the beholder, according ... (EBO), a publication of The American Journal of Managed Care. For the full issue, ...
(Date:6/26/2016)... ... June 26, 2016 , ... Pixel Film Studios Released ... , "Film editors can give their videos a whole new perspective by using the ... CEO of Pixel Film Studios. , ProSlice Levels contains over 30 Different presets ...
(Date:6/26/2016)... ... ... legally blind and certified personal trainer is helping to develop a weight loss fitness plan ... fix the two major problems leading the fitness industry today:, , ... They don’t eliminate all the reasons people quit their exercise program ...
(Date:6/25/2016)... Washington, D.C. (PRWEB) , ... June 25, 2016 ... ... will discuss health policy issues and applications at AcademyHealth’s Annual Research Meeting June ... share their work on several important health care topics including advance care planning, ...
(Date:6/25/2016)... ... ... The temporary closing of Bruton Memorial Library on June 21 due to a possible lice ... overlooked aspect of head lice: the parasite’s ability to live away from a human host, ... a necessary one in the event that lice have simply gotten out of control. , ...
Breaking Medicine News(10 mins):