- Data from more than 2,300 patients in large post-marketing, observational ORHEO study is now available online
LEAMINGTON SPA, England, July 24, 2014 /PRNewswire/ -- Hospira (NYSE: HSP), the world's leading provider of injectable drugs and infusion technologies, announced today that the results from the ORHEO study (place of biOsimilaRs in the therapeutic management of anemia secondary to chemotherapy in HaEmatology and Oncology) have been published in BMC Cancer, and show that the company's European biosimilar epoetin, Retacrit™ (epoetin zeta) was effective and well tolerated in the management of chemotherapy-induced anemia in patients with solid tumors, lymphoma and myeloma.1
The ORHEO study, conducted in France to treat oncology patients suffering from chemotherapy-induced anemia due to malignancy, was a prospective, observational study in which 2,310 adult patients (99.9 percent receiving epoetin zeta) were evaluated with chemotherapy-induced anemia and solid tumors, lymphomas or myelomas. The primary endpoint was the rate of response (defined as an increase in haemoglobin (Hb) levels to at least 10 g/dL since inclusion visit; if there had been an increase in Hb levels of at least 1 g/dL since the inclusion visit; reaching target Hb levels set at start of study, without any blood transfusions in the three weeks prior to measurement) at plus three months.1 The ORHEO study demonstrated that more than 80 percent of patients receiving Retacrit achieved a pre-defined Hb response in a real-world clinical setting, and that this was maintained at month six.1 Of the patients in the study, 17.1 percent experienced an adverse event (AE), in line with rates typically seen for the reference product. Retacrit was well tolerated in this study, with an overall rate of thrombotic events at 3.5 percent. In this observational study, no epoetin zeta-related deaths were reported.
"Biosimilars have an important role to play in the future of medicine, and because they are more cost effective than their reference products, it is estimated they will save European healthcare systems between €11.8 bn and €33.4 bn between 2007 and 20202," said Stan Bukofzer, Corporate Vice President and Chief Medical Officer, Hospira. "The ORHEO study provides important information on how Retacrit is benefiting patients in the clinic, and helps to demonstrate the potential of biosimilar epoetins to benefit patients while reducing healthcare costs."
In addition to the main study, a post-hoc sub-analysis of data from the ORHEO study has shown that Retacrit was effective and well tolerated in elderly people, with patients aged 70 years and over having comparable experiences to younger patients.3 The sub-analysis was presented last month at the International Symposium on Supportive Care in Cancer 2014, a joint meeting of the Multinational Association of Supportive Care in Cancer (MASCC) and the International Society of Oral Oncology (ISOO), held in Miami, USA.
Retacrit (epoetin zeta) was approved in Europe in 2007 as a biosimilar medicine to the reference biological product, epoetin alfa. Retacrit is an erythropoiesis-stimulating agent, which is intended to correct and maintain red blood cell counts. Retacrit is used to:
- treat anaemia (low red-blood-cell counts) that is causing symptoms in patients with chronic renal failure (long-term, progressive decrease in the ability of the kidneys to work properly) or other kidney problems;
- treat anaemia in adults receiving chemotherapy to treat certain types of cancer and to reduce the need for blood transfusions;
- increase the amount of blood that patients with moderate anaemia can self-donate before surgery, so that their own blood can be given back to them during or after surgery;
- reduce the need for blood transfusions in patients with moderate anaemia about to undergo major bone surgery (such as a hip or knee replacement).
Hospira has many years of experience in the field of biologics and one of the largest biosimilar pipelines in the industry. It is the only North American-based company with biosimilars on the European market, including Retacrit (epoetin zeta) which was launched in Europe in early 2008 and Nivestim™ (filgrastim), which entered the European market in 2010 and the Australian market in 2011. Hospira's first biosimilar monoclonal antibody (mAb), Inflectra™ (infliximab), received European approval in 2013 and is being introduced in select European markets.
Hospira, Inc. is the world's leading provider of injectable drugs and infusion technologies, and a global leader in biosimilars. 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 17,000 employees. Learn more at www.hospira.com.
The head office for Hospira in Europe, Middle East and Africa is in Leamington Spa, UK.
Private Securities Litigation Reform Act of 1995 –
A Caution Concerning Forward-Looking Statements
This press release contains, or may contain, forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding Hospira's biosimilars program and study results related to Retacrit. Hospira cautions that these forward-looking statements are subject to risks and uncertainties, including adequate and sustained progress on the company's quality initiatives and device strategy that may cause actual results to differ materially from those indicated in the forward-looking statements. Economic, competitive, governmental, regulatory, legal, technological, manufacturing, supply, quality, modernizing and streamlining activities, and other factors that may affect Hospira's operations and may cause actual results to be materially different from expectations include the risks, uncertainties and other factors discussed under the headings "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Hospira's latest Annual Report on Form 10-K and subsequent Forms 10-Q filed with the Securities and Exchange Commission, are incorporated by reference. Hospira undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
1 Michallet M, Luporsi E, Soubeyran P, et al. BiOsimilaRs in the management of anaemia secondary to chemotherapy in HaEmatology and Oncology: results of the ORHEO observational study. BMC Cancer 2014; 14:503 (July 10, 2014); http://www.biomedcentral.com/1471-2407/14/503/abstract.
2 Haustein R, Millas C, Höer A, et al. Saving money in the European healthcare systems with biosimilars. Generics and Biosimilars Initiative Journal. 2012;1(3-4):120-6.
3 Soubeyran P, Kurtz JE, Michallet M, et al. Biosimilar epoetin for the management of chemotherapy-induced anaemia in elderly patients: a subanalysis of the ORHEO study. Presented at the MASCC 2014 Symposium, 26-28 June 2014. Abstract available at http://mascc2014.meetingxpert.net/mascc_595/poster_97015/program.aspx/97015 [last accessed 23rd July 2014].