|By PR Newswire||
|March 10, 2014 01:30 PM EDT||
OXFORD, England, March 10, 2014 /PRNewswire/ --
New oral treatment can be offered as an alternative to currently available injectable treatment options
"The prevalence of multiple sclerosis in Scotland is one of the highest in the world, so the approval of Aubagio as another treatment option will be welcomed by the Scottish MS community. Aubagio is an oral drug, taken once daily and this makes it an exciting development both for people with MS and their clinicians, providing more choice and an alternative to injections. This is a really positive development for the future of treatment for relapsing remitting MS," commented Amy Bowen, Director of Service Development at the MS Trust.
The Scottish Medicines Consortium (SMC) today published its advice that Aubagio® (teriflunomide) 14 mg tablets has been accepted for use by NHS Scotland for the treatment of adults with relapsing remitting multiple sclerosis (RRMS), as an alternative to the currently available treatment options beta interferon or glatiramer acetate. The guidance does not include patients with highly active MS.
The guidance published by the SMC today represents an important step in improving the standard of care available to people with MS. "MS is a real concern in Scotland as it is a debilitating disease which has a high prevalence. This is good news for people with MS in Scotland and a significant milestone in improving the care of MS patients here," said Dr. Belinda Weller, Consultant Neurologist, Western General Hospital, Edinburgh.
Scotland has among the highest prevalence of MS in the world, with around 10,000 people living with MS in the country. Eighty-five percent of people with MS are initially diagnosed with RRMS and people with this type of MS experience approximately one or two relapses per year. Around half of all relapses may leave people with lingering problems and disability may accumulate over time.,
Aubagio is the first medicine in Genzyme's pipeline of MS therapies to receive final SMC guidance and become available to patients in Scotland. "This is a very exciting time and the launch of Aubagio represents an important milestone for Genzyme as we provide new options to the MS community. Our commitment to improving the lives of people with MS goes beyond advancing treatment options, and we have a patient support programme underway to further support patients with adherence," said Brendan Martin, General Manager for Genzyme UK and Ireland.
Online media resources available here: www.mspressoffice.co.uk.
Aubagio is an immunomodulator with anti-inflammatory properties. The exact mechanism by which teriflunomide exerts its therapeutic effect in MS is not fully understood, but this is mediated by a reduced number of lymphocytes. Aubagio is supported by an extensive multicentre, multi-country clinical programme, with more than 2,700 trial participants. Some patients in extension trials have been treated for up to 8.5 years.
EU Indication and Usage
Aubagio (teriflunomide 14 mg) is a once-daily, oral therapy indicated in the European Union for the treatment of adult patients with relapsing remitting multiple sclerosis.
Genzyme has introduced a risk management plan to ensure that is used as safely as possible. Based on this plan, safety information has been included in the Summary of Product Characteristics (SPC) and the Patient Information Leaflet for Aubagio, including the appropriate precautions to be followed, as described in Educational Materials to be used by healthcare professionals and patients.
For full prescribing information about Aubagio, the Summary of Product Characteristics can be found here http://www.medicines.org.uk/emc/medicine/28533/SPC/AUBAGIO+14+mg+film-coated+tablets/
About Genzyme, a Sanofi Company
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. That goal guides and inspires us every day. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represents groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients.
About Genzyme in the UK
Genzyme is a significant force in the UK biotechnology sector focused on improving the lives of patients with rare genetic diseases and multiple sclerosis. First established in the UK in 1981, Genzyme employs 450 people at two sites. Genzyme Therapeutics in Oxford is the company's UK commercial base marketing products for the treatment of patients with chronic debilitating diseases. These include genetic diseases such as lysosomal storage disorders (LSDs) - characterised by a lack of enzymes essential to healthy biological processes - and multiple sclerosis - a complex neurological disease affecting the central nervous system. Our portfolio also includes a therapy which aids in the management of thyroid cancer.
Genzyme's manufacturing facility in Haverhill, Suffolk, now integrated with Sanofi's Pharma Operations Unit, has undergone a dramatic building programme since its purchase in 1982 and now employs 380 people at a site with two large-scale manufacturing plants, a pilot plant, a development centre, warehouse and other associated facilities. The Haverhill facility manufactures the active ingredients in therapies for patients undergoing renal dialysis and is a major global distribution centre for Genzyme's products for genetic diseases. Learn more at http://www.genzyme.co.uk
Genzyme® is a registered trademark. All rights reserved
1. SMC guidance. teriflunomide, 14mg, film-coated tablets (Aubagio®) http://www.scottishmedicines.org.uk
2. Scottish Public Health Authority. Multiple sclerosis: key points. Available online at www.scotpho.org.uk/health-wellbeing-and-disease/multiple-sclerosis/key-points [Accessed December 2013]
3. MS Society UK. Relapsing-Remitting MS (RRMS). http://www.mssociety.org.uk/what-is-ms/types-of-ms/relapsing-remitting-rrms [Accessed January 2014]
4. Multiple Sclerosis Trust. Types of MS. http://www.mstrust.org.uk/atoz/types.jsp [Accessed October 2013]
5. Aubagio Summary of Product Characteristics November 2013
6. EPAR Summary for the public. Aubagio (teriflunomide). European Medicines Agency. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/002514/WC500148685.pdf. [Accessed December 2013]
7. Confavreux C et al. Teriflunomide Multiple Sclerosis Trial Group. Long-term follow-up of a phase 2 study of oral teriflunomide in relapsing multiple sclerosis: safety and efficacy results up to 8.5 years. Mult Scler J 2012 Sep;18(9):1278-1289
Enterprises have forever faced challenges surrounding the sharing of their intellectual property. Emerging cloud adoption has made it more compelling for enterprises to digitize their content, making them available over a wide variety of devices across the Internet. In his session at 19th Cloud Expo, Santosh Ahuja, Director of Architecture at Impiger Technologies, will introduce various mechanisms provided by cloud service providers today to manage and share digital content in a secure manner....
Aug. 28, 2016 09:30 AM EDT Reads: 756
StarNet Communications Corp has announced the addition of three Secure Remote Desktop modules to its flagship X-Win32 PC X server. The new modules enable X-Win32 to safely tunnel the remote desktops from Linux and Unix servers to the user’s PC over encrypted SSH. Traditionally, users of PC X servers deploy the XDMCP protocol to display remote desktop environments such as the Gnome and KDE desktops on Linux servers and the CDE environment on Solaris Unix machines. XDMCP is used primarily on comp...
Aug. 28, 2016 09:30 AM EDT Reads: 693
Fact: storage performance problems have only gotten more complicated, as applications not only have become largely virtualized, but also have moved to cloud-based infrastructures. Storage performance in virtualized environments isn’t just about IOPS anymore. Instead, you need to guarantee performance for individual VMs, helping applications maintain performance as the number of VMs continues to go up in real time. In his session at Cloud Expo, Dhiraj Sehgal, Product and Marketing at Tintri, wil...
Aug. 28, 2016 07:30 AM EDT Reads: 769
DevOps at Cloud Expo, taking place Nov 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 19th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long dev...
Aug. 28, 2016 07:00 AM EDT Reads: 2,393
SYS-CON Events announced today that Isomorphic Software will exhibit at DevOps Summit at 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Isomorphic Software provides the SmartClient HTML5/AJAX platform, the most advanced technology for building rich, cutting-edge enterprise web applications for desktop and mobile. SmartClient combines the productivity and performance of traditional desktop software with the simp...
Aug. 28, 2016 03:30 AM EDT Reads: 2,356
With so much going on in this space you could be forgiven for thinking you were always working with yesterday’s technologies. So much change, so quickly. What do you do if you have to build a solution from the ground up that is expected to live in the field for at least 5-10 years? This is the challenge we faced when we looked to refresh our existing 10-year-old custom hardware stack to measure the fullness of trash cans and compactors.
Aug. 28, 2016 02:00 AM EDT Reads: 1,780
Extreme Computing is the ability to leverage highly performant infrastructure and software to accelerate Big Data, machine learning, HPC, and Enterprise applications. High IOPS Storage, low-latency networks, in-memory databases, GPUs and other parallel accelerators are being used to achieve faster results and help businesses make better decisions. In his session at 18th Cloud Expo, Michael O'Neill, Strategic Business Development at NVIDIA, focused on some of the unique ways extreme computing is...
Aug. 28, 2016 01:45 AM EDT Reads: 2,161
The emerging Internet of Everything creates tremendous new opportunities for customer engagement and business model innovation. However, enterprises must overcome a number of critical challenges to bring these new solutions to market. In his session at @ThingsExpo, Michael Martin, CTO/CIO at nfrastructure, outlined these key challenges and recommended approaches for overcoming them to achieve speed and agility in the design, development and implementation of Internet of Everything solutions wi...
Aug. 28, 2016 01:30 AM EDT Reads: 2,099
Cloud computing is being adopted in one form or another by 94% of enterprises today. Tens of billions of new devices are being connected to The Internet of Things. And Big Data is driving this bus. An exponential increase is expected in the amount of information being processed, managed, analyzed, and acted upon by enterprise IT. This amazing is not part of some distant future - it is happening today. One report shows a 650% increase in enterprise data by 2020. Other estimates are even higher....
Aug. 28, 2016 01:00 AM EDT Reads: 2,969
Today we can collect lots and lots of performance data. We build beautiful dashboards and even have fancy query languages to access and transform the data. Still performance data is a secret language only a couple of people understand. The more business becomes digital the more stakeholders are interested in this data including how it relates to business. Some of these people have never used a monitoring tool before. They have a question on their mind like “How is my application doing” but no id...
Aug. 28, 2016 12:15 AM EDT Reads: 1,839
The 19th International Cloud Expo has announced that its Call for Papers is open. Cloud Expo, to be held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, brings together Cloud Computing, Big Data, Internet of Things, DevOps, Digital Transformation, Microservices and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding business opportuni...
Aug. 27, 2016 11:00 PM EDT Reads: 4,011
Identity is in everything and customers are looking to their providers to ensure the security of their identities, transactions and data. With the increased reliance on cloud-based services, service providers must build security and trust into their offerings, adding value to customers and improving the user experience. Making identity, security and privacy easy for customers provides a unique advantage over the competition.
Aug. 27, 2016 08:45 PM EDT Reads: 2,364
Qosmos has announced new milestones in the detection of encrypted traffic and in protocol signature coverage. Qosmos latest software can accurately classify traffic encrypted with SSL/TLS (e.g., Google, Facebook, WhatsApp), P2P traffic (e.g., BitTorrent, MuTorrent, Vuze), and Skype, while preserving the privacy of communication content. These new classification techniques mean that traffic optimization, policy enforcement, and user experience are largely unaffected by encryption. In respect wit...
Aug. 27, 2016 08:45 PM EDT Reads: 1,784
19th Cloud Expo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy. Meanwhile, 94% of enterpri...
Aug. 27, 2016 06:00 PM EDT Reads: 3,108
Smart Cities are here to stay, but for their promise to be delivered, the data they produce must not be put in new siloes. In his session at @ThingsExpo, Mathias Herberts, Co-founder and CTO of Cityzen Data, will deep dive into best practices that will ensure a successful smart city journey.
Aug. 27, 2016 05:15 PM EDT Reads: 1,589