|By PR Newswire||
|November 21, 2012 07:02 PM EST||
HATFIELD, England, November 22, 2012 /PRNewswire/ --
The All Wales Strategic Medical Group (AWSMG) has approved Zebinix® (eslicarbazepine acetate) for the treatment of partial seizures in highly refractory patients who remain uncontrolled with, or are intolerant to, other anti-epileptic medicine combinations. Eslicarbazepine acetate is licenced in Europe as an adjunctive therapy for adults with partial-onset seizures with or without secondary generalisation.
"There are 32,000 people in Wales living with epilepsy. Epilepsy is a complex condition which can be very difficult to treat. Up to 70 per cent of people with epilepsy could have their seizures controlled but only 52 per cent actually do. We welcome the decision by the AWSMG to make Zebinix available as an add-on treatment for people with difficult to control epilepsy who could benefit from this epilepsy medicine," commented Ann Sivapatham, Epilepsy Action's Wales Manager.
Epilepsy affects nearly 32,000 people in Wales. The successful treatment of partial-onset seizures (the most common form of epilepsy) remains a significant challenge in some patients and the incidence of uncontrolled partial epilepsy remains high, between 20 - 40% of patients with epilepsy have remained poorly controlled despite these treatments, despite many existing anti-epileptic drugs (AEDs).
Nick Burgin, Director Market Access, Eisai EMEA & Russia explained: "We are delighted that AWSMG has approved Zebinix for partial epilepsy. We want to ensure that patients have access to innovative treatments, encouraging better patient outcomes and faster uptake of new medicines."
Zebinix was approved by the European Commission following data which showed that it reduces seizure frequency and has an overall positive efficacy and safety profile.Zebinix is already available in Albania*, Austria, Czech Republic, Cyprus*, Denmark, England, Finland, France, Germany, Greece, Iceland, Malta*, Norway, Portugal*, Republic of Ireland, Scotland, Sweden, Spain (co-promotion with BIAL, the developer of Zebinix) and Wales.
Notes to Editors
Zebinix® is the EU trade name for eslicarbazepine acetate
Zebinix® is under license from BIAL except in those countries marked with an asterix, where it is exclusively by Bial
About epilepsy, partial-onset seizures and their treatment
Epilepsy is a chronic neurological disease characterised by abnormal discharges of neuronal activity causing seizures. Depending on the seizure type, seizures may be limited to one part of the body, or may be generalised to involve the whole body. Patients may also experience abnormal sensations, altered behaviour or altered consciousness. Epilepsy is a disorder with many possible causes. Often the cause of epilepsy is unknown. However, anything that disturbs the normal pattern of neuron activity - from illness to brain damage to tumours, can lead to seizures.
Epilepsy is characterised by abnormal firing of impulses from nerve cells in the brain. In partial-onset seizures, these bursts of electrical activity are initially focused in specific areas of the brain, but may become more generalised, the symptoms vary according to the affected areas.
Epilepsy is one of the world's most common neurological disorders, affecting more than six million people across Europe. With significant health care costs and economic impacts, uncontrolled seizures also increase the risk of psychological comorbidities, such as anxiety and depression.
About Zebinix®(eslicarbazepine acetate)
Eslicarbazepine acetate is a voltage-gated sodium channel blocker. It preferably targets the inactivated state of the sodium ion channel, preventing its return to the active state, and thereby reduces repetitive neuronal firing. Recent studies have also demonstrated that eslicarbazepine acetate effectively inhibits voltage-gated calcium channels, therefore enhancing its potential as an anti-epileptic agent. The efficacy of eslicarbazepine acetate was demonstrated in an initial proof-of-concept phase II study and three subsequent phase III randomised, placebo controlled studies in 1049 patients with refractory partial onset seizures.,,
The EU approval was based on data from a phase II and three phase III clinical trials.[9,10,11,12] Patients recruited in the phase III trials had a history of at least four partial seizures per month despite treatment between one to three concomitant anti-epileptic drugs.,,
During the trials, patients were randomised to various dosages of Zebinix® or placebo and after a 2-week titration period, were assessed over a 12-week maintenance period, with continued follow-up over a one year open-label period.[10,11,12,16,17,18]
Over the 12-week maintenance period, Zebinix® 800mg and 1200mg once-daily significantly reduced seizure frequency, and was significantly more effective than placebo.[9,10,11,12] Long-term safety and maintenance of therapeutic effect was demonstrated in one-year open-label extensions of these studies.[13,14,15]
In the Phase III clinical trials adverse events mainly occurred during the first 6 weeks of treatment and the majority of patients experienced adverse events of mild to moderate intensity. After the initial 6 weeks of treatment there were no observed differences in the incidence of side effects between patients treated with Zebinix® and the placebo group. The most common treatment-emergent adverse events in the pivotal studies were dizziness, headache and somnolence.
Eisai Europe Limited,a European subsidiary of Eisai Co., Ltd. announced in February 2009 that it had entered into a license and co-promotion agreement with BIAL - Portela & Cª, S.A. (Headquarters: São. Mamede do Coronado, Portugal, "BIAL"), which gave Eisai Europe Limited rights to sell BIAL's anti-epileptic drug Zebinix®(eslicarbazepine acetate) in Europe.
About Eisai EMEA in Epilepsy:
Eisai is committed to developing and delivering highly beneficial new treatments to help improve the lives of people with epilepsy. The development of AEDs is a major strategic area for Eisai in Europe, the Middle East, Africa and Russia (EMEA).
In the EMEA region, Eisai currently has four marketed treatments including:
- Zonegran® (zonisamide) as monotherapy and adjunctive therapy in adult patients with partial-onset seizures, with or without secondary generalisation. (Zonegran is under license from the originator Dainippon Sumitomo Pharma)
- Zebinix® (eslicarbazepine acetate) as adjunctive therapy in adult patients with partial-onset seizures, with or without secondary generalisation. (Zebinix is under license from BIAL)
- Inovelon® (rufinamide) for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in patients >4 years
- Fycompa® (perampanel) for use as an adjunctive treatment for partial onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older
Eisai recently expanded their UK Hatfield commercial, research and manufacturing facility which now supports the company's growing EMEA business.
Eisai concentrates its R&D activities in three key areas:
- Neuroscience, including: Alzheimer's disease, epilepsy, pain and weight loss
- Oncology including: anticancer therapies; tumour regression, tumour suppression, antibodies, etc
- Vascular/Immunological reaction including: thrombocytopenia, rheumatoid arthritis, psoriasis, inflammatory bowel disease
With operations in the U.S., Asia, Europe and its domestic home market of Japan, Eisai employs more than 11,000 people worldwide. In Europe, Eisai undertakes sales and marketing operations in over 20 markets, including the United Kingdom, France, Germany, Italy, Spain, Switzerland, Sweden, Ireland, Austria, Denmark, Finland, Norway, Portugal, Iceland, Czech Republic, Slovakia, the Netherlands, Belgium, Luxembourg, the Middle East and Russia.
For further information please visit our web site http://www.eisai.com.
Founded in 1924, BIAL is an international pharmaceutical group with products available in more than 50 countries throughout four continents. BIAL is a privately held Portuguese research based pharmaceutical company and the largest Portuguese pharmaceutical company, based in S. Mamede do Coronado, Portugal, responsible for the research and development of eslicarbazepine acetate (Zebinix®).
It is the partner of choice for many pharma companies, having a strong presence in the Iberian Peninsula as well as in over 10 countries in Latin America and in around 20 French or Portuguese speaking African countries.
BIAL is strongly committed to therapeutic innovation investing more than 20% of its turnover in research and development every year. Key research areas for BIAL are the central nervous system, the cardiovascular system and allergen immunotherapy. BIAL currently has several other innovative programs under development, which the company expects to bring to the market within the next years, thereby strengthening its position throughout Europe.
Further information about BIAL can be found at http://www.bial.com
1. AWSMG advice on Zebinix available at: http://www.wales.nhs.uk/sites3/Documents/371/Eslicarbazepine%20%28Zebinix%29%20FAR.pdf [http://www.wales.nhs.uk/sites3/Documents/371/Eslicarbazepine %28Zebinix%29 FAR.pdf ]
2. Joint Epilepsy Council. http://www.jointepilepsycouncil.org.uk/downloads/2011/Joint%20Epilepsy%20Council%20Prevalence%20and%20Incidence%20September%2011.pdf [http://www.jointepilepsycouncil.org.uk/downloads/2011/Joint Epilepsy Council Prevalence and Incidence September 11.pdf ]
3. French JA. Refractory Epilepsy; Clinical Overview. Epilepsia 2007: 48 (Suppl1) 3 - 7
4. Epilepsy Research UK. What is Epilepsy? Fact sheet.: http://www.epilepsyresearch.org.uk/about_us/leaflets/lflt1.htm (accessed March 2012)
5. Epilepsy Action. Describing Seizure Types. http://www.epilepsy.org.uk/info/seizures/ataglance (Accessed March 2012)
6. NHS Choices. Symptoms of Epilepsy. http://www.nhs.uk/Conditions/Epilepsy/Pages/Symptoms.aspx (Accessed March 2012)
7. The Lancet Neurology. 2010 Oct; 9(10): 941
8. Pugliatti M et al. Epilepsia 2007: 48(12) 2224 - 2233.
9. Titlic, M. Basic, S. Hajnek, S. Bratisl Lek Listy (Bratislava Medical Journal) 2009; 110 (2): 105 - 109
10. Almeida L, Soares-da-Silva P. Eslicarbazepine acetate (BIA 2-093). Neurotherapeutics. 2007 Jan;4(1):88-96
11. Brady K et al. Abstract presented at International Epilepsy Congress 2011 p858.
12. Elger et al. Epilepsia, 48(3):497-504, 2007
13. Elger C, Halász P, Maia J et al. Epilepsia 2009; 50(3):454-463
14. Ben-Menachem E, Gabbai A, Hufnagel A, Maia J, Almeida L, Soares-da-Silver P. Epilepsy Research 2010;89:278-285.
15. Gil-Nagel A, Lopes-Lima J, Maia J et al. Acta Neurol Scand 2009: 120: 281-287
16. Halász P, Elger C, Guekht A, et al. Epilepsia, 51(10):1963-1969, 2010
17. Gabbai A, Ben-Menachem E, Maia J, et al. Epilepsia. 2008;49(Suppl. 7):432-3
18. Lopes-Lima J, Gil-Nagel A, Maia J, et al. Epilepsia. 2008;49(Suppl. 7):441-2.
Date of preparation: November 2012
The Internet of Things is clearly many things: data collection and analytics, wearables, Smart Grids and Smart Cities, the Industrial Internet, and more. Cool platforms like Arduino, Raspberry Pi, Intel's Galileo and Edison, and a diverse world of sensors are making the IoT a great toy box for developers in all these areas. In this Power Panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, panelists discussed what things are the most important, which will have the most profound effect on the world, and what should we expect to see over the next couple of years.
Nov. 24, 2015 10:30 PM EST Reads: 401
PubNub has announced the release of BLOCKS, a set of customizable microservices that give developers a simple way to add code and deploy features for realtime apps.PubNub BLOCKS executes business logic directly on the data streaming through PubNub’s network without splitting it off to an intermediary server controlled by the customer. This revolutionary approach streamlines app development, reduces endpoint-to-endpoint latency, and allows apps to better leverage the enormous scalability of PubNub’s Data Stream Network.
Nov. 24, 2015 10:00 PM EST Reads: 253
I recently attended and was a speaker at the 4th International Internet of @ThingsExpo at the Santa Clara Convention Center. I also had the opportunity to attend this event last year and I wrote a blog from that show talking about how the “Enterprise Impact of IoT” was a key theme of last year’s show. I was curious to see if the same theme would still resonate 365 days later and what, if any, changes I would see in the content presented.
Nov. 24, 2015 08:00 PM EST Reads: 337
Apps and devices shouldn't stop working when there's limited or no network connectivity. Learn how to bring data stored in a cloud database to the edge of the network (and back again) whenever an Internet connection is available. In his session at 17th Cloud Expo, Ben Perlmutter, a Sales Engineer with IBM Cloudant, demonstrated techniques for replicating cloud databases with devices in order to build offline-first mobile or Internet of Things (IoT) apps that can provide a better, faster user experience, both offline and online. The focus of this talk was on IBM Cloudant, Apache CouchDB, and ...
Nov. 24, 2015 07:30 PM EST Reads: 341
Microservices are a very exciting architectural approach that many organizations are looking to as a way to accelerate innovation. Microservices promise to allow teams to move away from monolithic "ball of mud" systems, but the reality is that, in the vast majority of organizations, different projects and technologies will continue to be developed at different speeds. How to handle the dependencies between these disparate systems with different iteration cycles? Consider the "canoncial problem" in this scenario: microservice A (releases daily) depends on a couple of additions to backend B (re...
Nov. 24, 2015 06:00 PM EST Reads: 368
With all the incredible momentum behind the Internet of Things (IoT) industry, it is easy to forget that not a single CEO wakes up and wonders if “my IoT is broken.” What they wonder is if they are making the right decisions to do all they can to increase revenue, decrease costs, and improve customer experience – effectively the same challenges they have always had in growing their business. The exciting thing about the IoT industry is now these decisions can be better, faster, and smarter. Now all corporate assets – people, objects, and spaces – can share information about themselves and thei...
Nov. 24, 2015 05:30 PM EST Reads: 141
Two weeks ago (November 3-5), I attended the Cloud Expo Silicon Valley as a speaker, where I presented on the security and privacy due diligence requirements for cloud solutions. Cloud security is a topical issue for every CIO, CISO, and technology buyer. Decision-makers are always looking for insights on how to mitigate the security risks of implementing and using cloud solutions. Based on the presentation topics covered at the conference, as well as the general discussions heard between sessions, I wanted to share some of my observations on emerging trends. As cyber security serves as a fou...
Nov. 24, 2015 04:30 PM EST Reads: 285
Discussions of cloud computing have evolved in recent years from a focus on specific types of cloud, to a world of hybrid cloud, and to a world dominated by the APIs that make today's multi-cloud environments and hybrid clouds possible. In this Power Panel at 17th Cloud Expo, moderated by Conference Chair Roger Strukhoff, panelists addressed the importance of customers being able to use the specific technologies they need, through environments and ecosystems that expose their APIs to make true change and transformation possible.
Nov. 24, 2015 03:30 PM EST Reads: 459
There are over 120 breakout sessions in all, with Keynotes, General Sessions, and Power Panels adding to three days of incredibly rich presentations and content. Join @ThingsExpo conference chair Roger Strukhoff (@IoT2040), June 7-9, 2016 in New York City, for three days of intense 'Internet of Things' discussion and focus, including Big Data's indespensable role in IoT, Smart Grids and Industrial Internet of Things, Wearables and Consumer IoT, as well as (new) IoT's use in Vertical Markets.
Nov. 24, 2015 03:30 PM EST Reads: 507
Container technology is shaping the future of DevOps and it’s also changing the way organizations think about application development. With the rise of mobile applications in the enterprise, businesses are abandoning year-long development cycles and embracing technologies that enable rapid development and continuous deployment of apps. In his session at DevOps Summit, Kurt Collins, Developer Evangelist at Built.io, examined how Docker has evolved into a highly effective tool for application delivery by allowing increasingly popular Mobile Backend-as-a-Service (mBaaS) platforms to quickly crea...
Nov. 24, 2015 03:00 PM EST Reads: 284
The Internet of Things (IoT) is growing rapidly by extending current technologies, products and networks. By 2020, Cisco estimates there will be 50 billion connected devices. Gartner has forecast revenues of over $300 billion, just to IoT suppliers. Now is the time to figure out how you’ll make money – not just create innovative products. With hundreds of new products and companies jumping into the IoT fray every month, there’s no shortage of innovation. Despite this, McKinsey/VisionMobile data shows "less than 10 percent of IoT developers are making enough to support a reasonably sized team....
Nov. 24, 2015 02:00 PM EST Reads: 416
The cloud. Like a comic book superhero, there seems to be no problem it can’t fix or cost it can’t slash. Yet making the transition is not always easy and production environments are still largely on premise. Taking some practical and sensible steps to reduce risk can also help provide a basis for a successful cloud transition. A plethora of surveys from the likes of IDG and Gartner show that more than 70 percent of enterprises have deployed at least one or more cloud application or workload. Yet a closer inspection at the data reveals less than half of these cloud projects involve production...
Nov. 24, 2015 01:45 PM EST Reads: 407
As organizations realize the scope of the Internet of Things, gaining key insights from Big Data, through the use of advanced analytics, becomes crucial. However, IoT also creates the need for petabyte scale storage of data from millions of devices. A new type of Storage is required which seamlessly integrates robust data analytics with massive scale. These storage systems will act as “smart systems” provide in-place analytics that speed discovery and enable businesses to quickly derive meaningful and actionable insights. In his session at @ThingsExpo, Paul Turner, Chief Marketing Officer at...
Nov. 24, 2015 01:45 PM EST Reads: 337
Internet of @ThingsExpo, taking place June 7-9, 2016 at Javits Center, New York City and Nov 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with the 18th International @CloudExpo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world and ThingsExpo New York Call for Papers is now open.
Nov. 24, 2015 01:30 PM EST Reads: 487
We all know that data growth is exploding and storage budgets are shrinking. Instead of showing you charts on about how much data there is, in his General Session at 17th Cloud Expo, Scott Cleland, Senior Director of Product Marketing at HGST, showed how to capture all of your data in one place. After you have your data under control, you can then analyze it in one place, saving time and resources.
Nov. 24, 2015 01:30 PM EST
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo 2016 in New York and Silicon Valley. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place Nov 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 17th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The Internet of Things (IoT) is the most profound cha...
Nov. 24, 2015 01:30 PM EST Reads: 480
We are rapidly moving to a brave new world of interconnected smart homes, cars, offices and factories known as the Internet of Things (IoT). Sensors and monitoring devices will touch every part of our lives. Let's take a closer look at the Internet of Things. The Internet of Things is a worldwide network of objects and devices connected to the Internet. They are electronics, sensors, software and more. These objects connect to the Internet and can be controlled remotely via apps and programs. Because they can be accessed via the Internet, these devices create a tremendous opportunity to inte...
Nov. 24, 2015 01:15 PM EST Reads: 478
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 Day 2 Keynote at 17th Cloud Expo, Sandy Carter, IBM General Manager Cloud Ecosystem and Developers, and a Social Business Evangelist, wil...
Nov. 24, 2015 01:00 PM EST Reads: 492
SYS-CON Events announced today that Kintone has been named "Bronze Sponsor" of SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. kintone promotes cloud-based workgroup productivity, transparency and profitability with a seamless collaboration space, build your own business application (BYOA) platform, and workflow automation system.
Nov. 24, 2015 12:00 PM EST Reads: 565
Cloud computing delivers on-demand resources that provide businesses with flexibility and cost-savings. The challenge in moving workloads to the cloud has been the cost and complexity of ensuring the initial and ongoing security and regulatory (PCI, HIPAA, FFIEC) compliance across private and public clouds. Manual security compliance is slow, prone to human error, and represents over 50% of the cost of managing cloud applications. Determining how to automate cloud security compliance is critical to maintaining positive ROI. Raxak Protect is an automated security compliance SaaS platform and ma...
Nov. 24, 2015 12:00 PM EST Reads: 333