|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.
Apache Hadoop is emerging as a distributed platform for handling large and fast incoming streams of data. Predictive maintenance, supply chain optimization, and Internet-of-Things analysis are examples where Hadoop provides the scalable storage, processing, and analytics platform to gain meaningful insights from granular data that is typically only valuable from a large-scale, aggregate view. One architecture useful for capturing and analyzing streaming data is the Lambda Architecture, represent...
Mar. 27, 2017 08:15 PM EDT Reads: 6,277
SYS-CON Events announced today that Ocean9will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Ocean9 provides cloud services for Backup, Disaster Recovery (DRaaS) and instant Innovation, and redefines enterprise infrastructure with its cloud native subscription offerings for mission critical SAP workloads.
Mar. 27, 2017 07:45 PM EDT Reads: 2,170
With billions of sensors deployed worldwide, the amount of machine-generated data will soon exceed what our networks can handle. But consumers and businesses will expect seamless experiences and real-time responsiveness. What does this mean for IoT devices and the infrastructure that supports them? More of the data will need to be handled at - or closer to - the devices themselves.
Mar. 27, 2017 07:30 PM EDT Reads: 4,566
In his session at DevOps Summit, Tapabrata Pal, Director of Enterprise Architecture at Capital One, will tell a story about how Capital One has embraced Agile and DevOps Security practices across the Enterprise – driven by Enterprise Architecture; bringing in Development, Operations and Information Security organizations together. Capital Ones DevOpsSec practice is based upon three "pillars" – Shift-Left, Automate Everything, Dashboard Everything. Within about three years, from 100% waterfall, C...
Mar. 27, 2017 06:45 PM EDT Reads: 12,909
Adding public cloud resources to an existing application can be a daunting process. The tools that you currently use to manage the software and hardware outside the cloud aren’t always the best tools to efficiently grow into the cloud. All of the major configuration management tools have cloud orchestration plugins that can be leveraged, but there are also cloud-native tools that can dramatically improve the efficiency of managing your application lifecycle.
Mar. 27, 2017 06:00 PM EDT Reads: 2,996
SYS-CON Events announced today that Juniper Networks (NYSE: JNPR), an industry leader in automated, scalable and secure networks, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Juniper Networks challenges the status quo with products, solutions and services that transform the economics of networking. The company co-innovates with customers and partners to deliver automated, scalable and secure network...
Mar. 27, 2017 03:45 PM EDT Reads: 1,404
DevOps is often described as a combination of technology and culture. Without both, DevOps isn't complete. However, applying the culture to outdated technology is a recipe for disaster; as response times grow and connections between teams are delayed by technology, the culture will die. A Nutanix Enterprise Cloud has many benefits that provide the needed base for a true DevOps paradigm. In his Day 3 Keynote at 20th Cloud Expo, Chris Brown, a Solutions Marketing Manager at Nutanix, will explore t...
Mar. 27, 2017 03:30 PM EDT Reads: 2,956
SYS-CON Events announced today that SoftLayer, an IBM Company, has been named “Gold Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. SoftLayer, an IBM Company, provides cloud infrastructure as a service from a growing number of data centers and network points of presence around the world. SoftLayer’s customers range from Web startups to global enterprises.
Mar. 27, 2017 02:45 PM EDT Reads: 1,952
SYS-CON Events announced today that Linux Academy, the foremost online Linux and cloud training platform and community, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Linux Academy was founded on the belief that providing high-quality, in-depth training should be available at an affordable price. Industry leaders in quality training, provided services, and student certification passes, its goal is to c...
Mar. 27, 2017 02:30 PM EDT Reads: 4,024
Some people worry that OpenStack is more flash then substance; however, for many customers this could not be farther from the truth. No other technology equalizes the playing field between vendors while giving your internal teams better access than ever to infrastructure when they need it. In his session at 20th Cloud Expo, Chris Brown, a Solutions Marketing Manager at Nutanix, will talk through some real-world OpenStack deployments and look into the ways this can benefit customers of all sizes....
Mar. 27, 2017 02:30 PM EDT Reads: 4,323
Deep learning has been very successful in social sciences and specially areas where there is a lot of data. Trading is another field that can be viewed as social science with a lot of data. With the advent of Deep Learning and Big Data technologies for efficient computation, we are finally able to use the same methods in investment management as we would in face recognition or in making chat-bots. In his session at 20th Cloud Expo, Gaurav Chakravorty, co-founder and Head of Strategy Development ...
Mar. 27, 2017 02:30 PM EDT Reads: 3,677
SYS-CON Events announced today that CA Technologies has been named “Platinum Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY, and the 21st International Cloud Expo®, which will take place October 31-November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. CA Technologies helps customers succeed in a future where every business – from apparel to energy – is being rewritten by software. From ...
Mar. 27, 2017 02:00 PM EDT Reads: 2,060
Interoute has announced the integration of its Global Cloud Infrastructure platform with Rancher Labs’ container management platform, Rancher. This approach enables enterprises to accelerate their digital transformation and infrastructure investments. Matthew Finnie, Interoute CTO commented “Enterprises developing and building apps in the cloud and those on a path to Digital Transformation need Digital ICT Infrastructure that allows them to build, test and deploy faster than ever before. The int...
Mar. 27, 2017 01:30 PM EDT Reads: 1,211
In his session at @ThingsExpo, Eric Lachapelle, CEO of the Professional Evaluation and Certification Board (PECB), will provide an overview of various initiatives to certifiy the security of connected devices and future trends in ensuring public trust of IoT. Eric Lachapelle is the Chief Executive Officer of the Professional Evaluation and Certification Board (PECB), an international certification body. His role is to help companies and individuals to achieve professional, accredited and worldw...
Mar. 27, 2017 01:15 PM EDT Reads: 748
SYS-CON Events announced today that Loom Systems will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Founded in 2015, Loom Systems delivers an advanced AI solution to predict and prevent problems in the digital business. Loom stands alone in the industry as an AI analysis platform requiring no prior math knowledge from operators, leveraging the existing staff to succeed in the digital era. With offices in S...
Mar. 27, 2017 01:00 PM EDT Reads: 1,478