|By PR Newswire||
|December 10, 2012 06:52 PM EST||
DUBLIN, Dec. 10, 2012 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that data from the largest safety trial to date of patients treated with Erwinaze® (asparaginase Erwinia chrysanthemi) have been presented at the American Society of Hematology Annual Meeting and Exposition taking place in Atlanta, Georgia. The poster, titled "L-Asparaginase (L-ASP) Related Toxicities with Asparaginase Erwinia Chrysanthemi in a Large Compassionate Use Protocol," was presented by Paul V. Plourde, M.D., senior vice president of clinical oncology at Jazz Pharmaceuticals.
The poster presentation is based on results of a compassionate use protocol in patients who received Erwinaze as part of a multi-agent chemotherapeutic regimen for acute lymphoblastic leukemia who developed a hypersensitivity to E.coli-derived asparaginase. The poster summarizes the safety results in 940 patients at participating U.S. oncology treatment centers between February 2006 and November 2011, when Erwinaze was available under a compassionate use protocol prior to its approval by the U.S. Food and Drug Administration in November 2011. The trial includes additional follow up data that further describe the incidence of adverse events associated with Erwinaze treatment, which are consistent with the known safety profile of Erwinaze.
"The extensive information collected in this study provides important information that further evaluates the safety profile of Erwinaze," stated Jeffrey Tobias, MD, executive vice president of research and development and chief medical officer of Jazz Pharmaceuticals. "This additional information may help physicians as they make important treatment decisions related to Erwinaze."
About Erwinaze: Indication and Important Safety Information
Erwinaze is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity to E.coli-derived asparaginase. Erwinaze was originally discovered by the UK Health Protection Agency. Erwinaze was approved by the U.S. Food and Drug Administration in November 2011.
Erwinaze is contraindicated in patients with a history of serious hypersensitivity to Erwinaze, including anaphylaxis; history of serious pancreatitis, thrombosis or hemorrhage with prior L-asparaginase therapy. Discontinue if serious hypersensitivity, including anaphylaxis, or severe or hemorrhagic pancreatitis occur. Monitor glucose at baseline and periodically during treatment since intolerance may not be reversible. With thrombosis and hemorrhage, discontinue until resolved. Use in pregnant women only if clearly needed. Do not use in lactating women. The most common adverse reactions (≥ 1%) are serious hypersensitivity, including anaphylaxis, pancreatitis, abnormal transaminases, coagulation abnormalities, nausea, vomiting, and hyperglycemia.
Please see full Prescribing Information at www.erwinaze.com.
About Acute Lymphoblastic Leukemia (ALL)
Acute lymphoblastic leukemia affects approximately 6,000 Americans, 60 percent of whom are children. ALL is the most common form of childhood cancer, with the peak incidence between two and five years of age. ALL can be life-threatening and progresses quickly if left untreated. A majority of asparaginase treatments derive from E. coli; however, approximately 15 to 20 percent of ALL patients develop hypersensitivity to E. coli-derived asparaginase regimens.
About Jazz Pharmaceuticals
Jazz Pharmaceuticals plc is a specialty biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing innovative products that address unmet medical needs. The company has a diverse portfolio of products in the areas of narcolepsy, oncology, pain and psychiatry. The company's U.S. marketed products in these areas include: Xyrem® (sodium oxybate) oral solution, Erwinaze® (asparaginase Erwinia chrysanthemi), Prialt® (ziconotide) intrathecal infusion, Luvox CR® (fluvoxamine maleate), FazaClo® (clozapine, USP) HD and FazaClo LD. Outside of the U.S., Jazz Pharmaceuticals also has a number of products marketed by its international division, EUSA Pharma.
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995
This press release contains forward-looking statements, including, but not limited to, statements related to future treatment decisions involving the potential use of Erwinaze and other statements that are not historical facts. These forward-looking statements are based on Jazz Pharmaceuticals' current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with effectively commercializing Erwinaze, risks related to market acceptance of Erwinaze by physicians and the medical community, and those other risks detailed from time to time under the caption "Risk Factors" and elsewhere in Jazz Pharmaceuticals' filings and reports with the Securities and Exchange Commission (Commission File No. 001-33500), including in Jazz Pharmaceuticals' Quarterly Report on Form 10-Q for the quarter ended September 30, 2012 and future filings and reports by the company. Jazz Pharmaceuticals undertakes no duty or obligation to update any forward-looking statements contained in this press release as a result of new information, future events or changes in its expectations.
SOURCE Jazz Pharmaceuticals plc
Culture is the most important ingredient of DevOps. The challenge for most organizations is defining and communicating a vision of beneficial DevOps culture for their organizations, and then facilitating the changes needed to achieve that. Often this comes down to an ability to provide true leadership. As a CIO, are your direct reports IT managers or are they IT leaders? The hard truth is that many IT managers have risen through the ranks based on their technical skills, not their leadership abi...
Mar. 27, 2017 05:00 AM EDT Reads: 11,021
The essence of cloud computing is that all consumable IT resources are delivered as services. In his session at 15th Cloud Expo, Yung Chou, Technology Evangelist at Microsoft, demonstrated the concepts and implementations of two important cloud computing deliveries: Infrastructure as a Service (IaaS) and Platform as a Service (PaaS). He discussed from business and technical viewpoints what exactly they are, why we care, how they are different and in what ways, and the strategies for IT to transi...
Mar. 27, 2017 05:00 AM EDT Reads: 6,129
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 04:00 AM EDT Reads: 998
Without a clear strategy for cost control and an architecture designed with cloud services in mind, costs and operational performance can quickly get out of control. To avoid multiple architectural redesigns requires extensive thought and planning. Boundary (now part of BMC) launched a new public-facing multi-tenant high resolution monitoring service on Amazon AWS two years ago, facing challenges and learning best practices in the early days of the new service.
Mar. 27, 2017 03:45 AM EDT Reads: 2,943
Niagara Networks exhibited at the 19th International Cloud Expo, which took place at the Santa Clara Convention Center in Santa Clara, CA, in November 2016. Niagara Networks offers the highest port-density systems, and the most complete Next-Generation Network Visibility systems including Network Packet Brokers, Bypass Switches, and Network TAPs.
Mar. 27, 2017 03:15 AM EDT Reads: 3,133
All organizations that did not originate this moment have a pre-existing culture as well as legacy technology and processes that can be more or less amenable to DevOps implementation. That organizational culture is influenced by the personalities and management styles of Executive Management, the wider culture in which the organization is situated, and the personalities of key team members at all levels of the organization. This culture and entrenched interests usually throw a wrench in the work...
Mar. 27, 2017 03:00 AM EDT Reads: 2,963
SYS-CON Events announced today that Outlyer, a monitoring service for DevOps and operations teams, has been named “Bronze 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. Outlyer is a monitoring service for DevOps and Operations teams running Cloud, SaaS, Microservices and IoT deployments. Designed for today's dynamic environments that need beyond cloud-scale monitoring, we make monitoring effortless so you ...
Mar. 27, 2017 02:15 AM EDT Reads: 4,135
My team embarked on building a data lake for our sales and marketing data to better understand customer journeys. This required building a hybrid data pipeline to connect our cloud CRM with the new Hadoop Data Lake. One challenge is that IT was not in a position to provide support until we proved value and marketing did not have the experience, so we embarked on the journey ourselves within the product marketing team for our line of business within Progress. In his session at @BigDataExpo, Sum...
Mar. 27, 2017 01:45 AM EDT Reads: 2,893
Virtualization over the past years has become a key strategy for IT to acquire multi-tenancy, increase utilization, develop elasticity and improve security. And virtual machines (VMs) are quickly becoming a main vehicle for developing and deploying applications. The introduction of containers seems to be bringing another and perhaps overlapped solution for achieving the same above-mentioned benefits. Are a container and a virtual machine fundamentally the same or different? And how? Is one techn...
Mar. 27, 2017 01:45 AM EDT Reads: 2,952
Keeping pace with advancements in software delivery processes and tooling is taxing even for the most proficient organizations. Point tools, platforms, open source and the increasing adoption of private and public cloud services requires strong engineering rigor - all in the face of developer demands to use the tools of choice. As Agile has settled in as a mainstream practice, now DevOps has emerged as the next wave to improve software delivery speed and output. To make DevOps work, organization...
Mar. 27, 2017 01:15 AM EDT Reads: 1,841
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.
Mar. 27, 2017 12:45 AM EDT Reads: 2,074
What sort of WebRTC based applications can we expect to see over the next year and beyond? One way to predict development trends is to see what sorts of applications startups are building. In his session at @ThingsExpo, Arin Sime, founder of WebRTC.ventures, will discuss the current and likely future trends in WebRTC application development based on real requests for custom applications from real customers, as well as other public sources of information,
Mar. 27, 2017 12:30 AM EDT Reads: 834
China Unicom exhibit at the 19th International Cloud Expo, which took place at the Santa Clara Convention Center in Santa Clara, CA, in November 2016. China United Network Communications Group Co. Ltd ("China Unicom") was officially established in 2009 on the basis of the merger of former China Netcom and former China Unicom. China Unicom mainly operates a full range of telecommunications services including mobile broadband (GSM, WCDMA, LTE FDD, TD-LTE), fixed-line broadband, ICT, data communica...
Mar. 27, 2017 12:00 AM EDT Reads: 3,332
With the introduction of IoT and Smart Living in every aspect of our lives, one question has become relevant: What are the security implications? To answer this, first we have to look and explore the security models of the technologies that IoT is founded upon. In his session at @ThingsExpo, Nevi Kaja, a Research Engineer at Ford Motor Company, will discuss some of the security challenges of the IoT infrastructure and relate how these aspects impact Smart Living. The material will be delivered i...
Mar. 26, 2017 09:45 PM EDT Reads: 2,048
As software becomes more and more complex, we, as software developers, have been splitting up our code into smaller and smaller components. This is also true for the environment in which we run our code: going from bare metal, to VMs to the modern-day Cloud Native world of containers, schedulers and micro services. While we have figured out how to run containerized applications in the cloud using schedulers, we've yet to come up with a good solution to bridge the gap between getting your contain...
Mar. 26, 2017 09:45 PM EDT Reads: 7,610