|By PR Newswire||
|April 28, 2014 05:04 AM EDT||
HURLEY, United Kingdom, April 28, 2014 /PRNewswire/ -- Hospira (NYSE: HSP), the world's leading provider of injectable drugs and infusion technologies, last week shared results from a post-authorization observational safety study, conducted in clinical sites in Europe, of biosimilar epoetin product Retacrit™/Silapo® (epoetin zeta) in patients with renal anaemia. The study's results, presented at the National Kidney Foundation 2014 Spring Clinical Meetings, exhibited a safety pattern for Retacrit/Silapo comparable with known data for other epoetin alfa products. Retacrit is marketed in Europe by Hospira, and Silapo is marketed in Germany by cell pharm GmbH, a 100% subsidiary of STADA Arzneimittel AG. Retacrit and Silapo are manufactured by STADA Arzneimittel AG.
The study, PASCO I (post-authorization safety cohort observational study), included anaemic patients with chronic kidney disease receiving haemodialysis and who were treated with Retacrit/Silapo administered intravenously for up to one year. Hospira conducted the study in conjunction with STADA Arzneimittel AG as part of the risk-management plan (RMP) post-approval commitment to the European Medicines Agency (EMA), and included safety data from more than 1,600 patients in four European countries. Approximately 94 percent of patients were treated previously with an erythropoiesis stimulating agent (ESA). The primary objective of PASCO I was to determine the incidence of adverse events of special interest (AESI) in patients being treated with Retacrit/Silapo for renal anaemia. The full abstract can be found here.
In the patients studied, treatment of renal anaemia with Retacrit/Silapo was found to have a safety profile consistent with that found in the Retacrit/Silapo registration trials with the same route of administration and in line with other ESAs.
"Importantly, this study showed a safety profile consistent with what was found in registration trials for Hospira and STADA's product," said Paul Audhya, M.D., vice president, Medical Affairs, Hospira. "Since their introduction in Europe, biosimilar medications have increased treatment options and improved patient access to biologic medications, including ESAs."
Frank Dellanna, M.D., of MVZ DaVita Karlstrasse, Düsseldorf, Germany, said, "This study contributes to current knowledge about the frequency of adverse events associated with the use of Retacrit/Silapo for the treatment of renal anaemia."
Hospira and STADA Arzneimittel AG are currently conducting an additional post-authorization observational safety study (PASCO II) intended to further the safety profile of Retacrit/Silapo given subcutaneously over a period of three years in 6,700 European patients being treated for anaemia associated with renal disease. As with PASCO I, this study is also being conducted as part of an RMP commitment to EMA for further pharmacovigilance surveillance.
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 Hurley, UK.
Private Securities Litigation Reform Act of 1995 –
A Caution Concerning Forward-Looking Statements
This press release contains 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 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, which are incorporated by reference. Hospira undertakes no obligation to release publicly any revisions to forward-looking statements as the result of subsequent events or developments.