|By PR Newswire||
|January 21, 2014 07:01 PM EST||
OXFORD, England, January 22, 2014 /PRNewswire/ --
"MS treatments have come a long way in recent years and we're moving into a new era where people with MS and their clinicians have more choice and a new alternative to injections. Having Aubagio available as an effective, simple, oral treatment option, which only needs to be taken once daily, is an exciting development for people with MS," commented Amy Bowen, Director of Service Development at the MS Trust.
A new once daily, oral treatment, Aubagio® (teriflunomide) will now be available on the NHS for people with a relapsing form of multiple sclerosis (RRMS). This does not include patients with highly active or rapidly evolving severe relapsing-remitting MS. Following today's National Institute for Health and Care Excellence (NICE) approval, adult patients with RRMS will be able to have access to treatment with Aubagio. RRMS accounts for eighty-five percent of all initial diagnoses in MS, and is a condition that has, until now, been limited to initial treatment options that are injectable.
Today's decision is welcomed by the MS community; in the UK alone, approximately 100,000 people are living with MS.The availability of Aubagio offers an alternative to adult patients who find it a burden and inconvenience to have to administer regular injections.
Aubagio® was granted marketing authorisation based on efficacy and safety data from two clinical trials., This, coupled with the fact that Aubagio® is a convenient, once-daily, oral treatment, has led to comments on NICE's positive approval today by Dr Benjamin Turner, Clinical Neurologist at Barts Health NHS Trust:. "This is good news for people with MS and is a significant milestone in improving the care of MS patients in the UK."
The NICE approval of Aubagio represents an alternative first line treatment for people with MS who have previously had to undergo regular injections. Aubagio® is the first medicine in Genzyme's pipeline of MS therapies to become available to patients in the UK
"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 in adherence," said Brendan Martin, General Manager for Genzyme UK and Ireland.
Additional resources available: see contact details below
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 Aubagio 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 ground-breaking 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 welfare of patients with rare inherited and neurological diseases. 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 illnesses, 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 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. Genzyme's Haverhill facility manufactures the active ingredients in Genzyme's therapies for patients undergoing renal dialysis and is a major global distribution centre for the company's products for genetic illnesses. Learn more at http://www.genzyme.co.uk
Genzyme® is a registered trademark. All rights reserved
1. National Institute for Health and Care Excellence. Final appraisal determination (FAD). Teriflunomide for treating relapsing-remitting multiple sclerosis. November 2013
2. MS Society. Relapsing Remitting (RRMS). http://www.mssociety.org.uk/what-is-ms/types-of-ms/relapsing-remitting-rrms [Accessed January 2014]
3. NICE Proposed Health Technology Appraisal. Alemtuzumab, dimethyl fumarate, laquinimod and teriflunomide for the treatment of relapsing forms of multiple sclerosis. Draft scope. http://www.nice.org.uk/nicemedia/live/14061/63485/63485.pdf [Accessed October 2013]
4. Miller AE et al. Teriflunomide Efficacy and Safety in Patients with Relapsing Multiple Sclerosis: Results From TOWER, a Second Pivotal Phase 3 Placebo-Controlled Study. Presented at the American Academy of Neurology (AAN) annual meeting, San Diego, 2013; S01.004.
5. O'Connor P et al. Randomized Trial of Oral Teriflunomide for Relapsing Multiple Sclerosis. N Engl J Med. 2011;365:1293-303
6. Aubagio Summary of Product Characteristics November 2013
7. 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]
8. 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.
Genzyme Media Relations (UK & Ireland)
Henry Featherstone - Genzyme
Tel: +44(0)7718 695 969
Email: [email protected]
Genzyme Media Relations (UK & Ireland)
Rosie Ireland - Weber Shandwick
Email: [email protected]
Genzyme Media Relations (UK & Ireland)
Samantha Gale - Weber Shandwick
Email: [email protected]
Explosive growth in connected devices. Enormous amounts of data for collection and analysis. Critical use of data for split-second decision making and actionable information. All three are factors in making the Internet of Things a reality. Yet, any one factor would have an IT organization pondering its infrastructure strategy. How should your organization enhance its IT framework to enable an Internet of Things implementation? In his session at @ThingsExpo, James Kirkland, Red Hat's Chief Arch...
Jul. 30, 2015 07:30 PM EDT Reads: 1,390
For IoT to grow as quickly as analyst firms’ project, a lot is going to fall on developers to quickly bring applications to market. But the lack of a standard development platform threatens to slow growth and make application development more time consuming and costly, much like we’ve seen in the mobile space. In his session at @ThingsExpo, Mike Weiner, Product Manager of the Omega DevCloud with KORE Telematics Inc., discussed the evolving requirements for developers as IoT matures and conducte...
Jul. 30, 2015 07:15 PM EDT Reads: 295
Providing the needed data for application development and testing is a huge headache for most organizations. The problems are often the same across companies - speed, quality, cost, and control. Provisioning data can take days or weeks, every time a refresh is required. Using dummy data leads to quality problems. Creating physical copies of large data sets and sending them to distributed teams of developers eats up expensive storage and bandwidth resources. And, all of these copies proliferating...
Jul. 30, 2015 06:30 PM EDT Reads: 880
Malicious agents are moving faster than the speed of business. Even more worrisome, most companies are relying on legacy approaches to security that are no longer capable of meeting current threats. In the modern cloud, threat diversity is rapidly expanding, necessitating more sophisticated security protocols than those used in the past or in desktop environments. Yet companies are falling for cloud security myths that were truths at one time but have evolved out of existence.
Jul. 30, 2015 06:00 PM EDT Reads: 1,796
Digital Transformation is the ultimate goal of cloud computing and related initiatives. The phrase is certainly not a precise one, and as subject to hand-waving and distortion as any high-falutin' terminology in the world of information technology. Yet it is an excellent choice of words to describe what enterprise IT—and by extension, organizations in general—should be working to achieve. Digital Transformation means: handling all the data types being found and created in the organizat...
Jul. 30, 2015 05:00 PM EDT Reads: 1,084
Public Cloud IaaS started its life in the developer and startup communities and has grown rapidly to a $20B+ industry, but it still pales in comparison to how much is spent worldwide on IT: $3.6 trillion. In fact, there are 8.6 million data centers worldwide, the reality is many small and medium sized business have server closets and colocation footprints filled with servers and storage gear. While on-premise environment virtualization may have peaked at 75%, the Public Cloud has lagged in adop...
Jul. 30, 2015 04:00 PM EDT Reads: 2,196
SYS-CON Events announced today that HPM Networks will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. For 20 years, HPM Networks has been integrating technology solutions that solve complex business challenges. HPM Networks has designed solutions for both SMB and enterprise customers throughout the San Francisco Bay Area.
Jul. 30, 2015 03:45 PM EDT Reads: 443
The time is ripe for high speed resilient software defined storage solutions with unlimited scalability. ISS has been working with the leading open source projects and developed a commercial high performance solution that is able to grow forever without performance limitations. In his session at Cloud Expo, Alex Gorbachev, President of Intelligent Systems Services Inc., shared foundation principles of Ceph architecture, as well as the design to deliver this storage to traditional SAN storage co...
Jul. 30, 2015 03:00 PM EDT Reads: 1,735
The Software Defined Data Center (SDDC), which enables organizations to seamlessly run in a hybrid cloud model (public + private cloud), is here to stay. IDC estimates that the software-defined networking market will be valued at $3.7 billion by 2016. Security is a key component and benefit of the SDDC, and offers an opportunity to build security 'from the ground up' and weave it into the environment from day one. In his session at 16th Cloud Expo, Reuven Harrison, CTO and Co-Founder of Tufin,...
Jul. 30, 2015 03:00 PM EDT Reads: 480
MuleSoft has announced the findings of its 2015 Connectivity Benchmark Report on the adoption and business impact of APIs. The findings suggest traditional businesses are quickly evolving into "composable enterprises" built out of hundreds of connected software services, applications and devices. Most are embracing the Internet of Things (IoT) and microservices technologies like Docker. A majority are integrating wearables, like smart watches, and more than half plan to generate revenue with ...
Jul. 30, 2015 02:30 PM EDT
The Cloud industry has moved from being more than just being able to provide infrastructure and management services on the Cloud. Enter a new era of Cloud computing where monetization’s services through the Cloud are an essential piece of strategy to feed your organizations bottom-line, your revenue and Profitability. In their session at 16th Cloud Expo, Ermanno Bonifazi, CEO & Founder of Solgenia, and Ian Khan, Global Strategic Positioning & Brand Manager at Solgenia, discussed how to easily o...
Jul. 30, 2015 01:45 PM EDT Reads: 373
The Internet of Everything (IoE) brings together people, process, data and things to make networked connections more relevant and valuable than ever before – transforming information into knowledge and knowledge into wisdom. IoE creates new capabilities, richer experiences, and unprecedented opportunities to improve business and government operations, decision making and mission support capabilities.
Jul. 30, 2015 01:45 PM EDT Reads: 259
In their session at 17th Cloud Expo, Hal Schwartz, CEO of Secure Infrastructure & Services (SIAS), and Chuck Paolillo, CTO of Secure Infrastructure & Services (SIAS), provide a study of cloud adoption trends and the power and flexibility of IBM Power and Pureflex cloud solutions. In his role as CEO of Secure Infrastructure & Services (SIAS), Hal Schwartz provides leadership and direction for the company.
Jul. 30, 2015 01:30 PM EDT
Rapid innovation, changing business landscapes, and new IT demands force businesses to make changes quickly. The DevOps approach is a way to increase business agility through collaboration, communication, and integration across different teams in the IT organization. In his session at DevOps Summit, Chris Van Tuin, Chief Technologist for the Western US at Red Hat, will discuss: The acceleration of application delivery for the business with DevOps
Jul. 30, 2015 12:45 PM EDT Reads: 1,112
Growth hacking is common for startups to make unheard-of progress in building their business. Career Hacks can help Geek Girls and those who support them (yes, that's you too, Dad!) to excel in this typically male-dominated world. Get ready to learn the facts: Is there a bias against women in the tech / developer communities? Why are women 50% of the workforce, but hold only 24% of the STEM or IT positions? Some beginnings of what to do about it! In her Opening Keynote at 16th Cloud Expo, S...
Jul. 30, 2015 12:00 PM EDT Reads: 2,046