Click here to close now.

Welcome!

Open Web Authors: Liz McMillan, Lori MacVittie, Gilad Parann-Nissany, Carmen Gonzalez, Mark R. Hinkle

News Feed Item

All Wales Strategic Medical Group Approves Zebinix® (Eslicarbazepine Acetate) - Once Daily Anti-Epileptic Treatment

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.[1]

"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.[2] 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).[3]

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.[4]

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,[5] but may become more generalised, the symptoms vary according to the affected areas.[6]

Epilepsy is one of the world's most common neurological disorders, affecting more than six million people across Europe.[7] With significant health care costs and economic impacts,[8] uncontrolled seizures also increase the risk of psychological comorbidities, such as anxiety and depression.[9]

About Zebinix®(eslicarbazepine acetate)

Eslicarbazepine acetate is a voltage-gated sodium channel blocker.[10] It preferably targets the inactivated state of the sodium ion channel, preventing its return to the active state, and thereby reduces repetitive neuronal firing.[10] Recent studies have also demonstrated that eslicarbazepine acetate effectively inhibits voltage-gated calcium channels, therefore enhancing its potential as an anti-epileptic agent.[11] The efficacy of eslicarbazepine acetate was demonstrated in an initial proof-of-concept phase II study[12] and three subsequent phase III randomised, placebo controlled studies in 1049 patients with refractory partial onset seizures.[13],[14],[15]

Clinical data

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.[10],[11],[12]

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]

Efficacy

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]

Tolerability[9,10,11,12]

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.

License Agreement

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

About Eisai:

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.

About BIAL

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

References

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

Zebinix-UK2265

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

@ThingsExpo Stories
The world's leading Cloud event, Cloud Expo has launched Microservices Journal on the SYS-CON.com portal, featuring over 19,000 original articles, news stories, features, and blog entries. DevOps Journal is focused on this critical enterprise IT topic in the world of cloud computing. Microservices Journal offers top articles, news stories, and blog posts from the world's well-known experts and guarantees better exposure for its authors than any other publication. Follow new article posts on Twitter at @MicroservicesE
SYS-CON Events announced today the IoT Bootcamp – Jumpstart Your IoT Strategy, being held June 9–10, 2015, in conjunction with 16th Cloud Expo and Internet of @ThingsExpo at the Javits Center in New York City. This is your chance to jumpstart your IoT strategy. Combined with real-world scenarios and use cases, the IoT Bootcamp is not just based on presentations but includes hands-on demos and walkthroughs. We will introduce you to a variety of Do-It-Yourself IoT platforms including Arduino, Raspberry Pi, BeagleBone, Spark and Intel Edison. You will also get an overview of cloud technologies s...
SYS-CON Events announced today that SafeLogic has been named “Bag Sponsor” of SYS-CON's 16th International Cloud Expo® New York, which will take place June 9-11, 2015, at the Javits Center in New York City, NY. SafeLogic provides security products for applications in mobile and server/appliance environments. SafeLogic’s flagship product CryptoComply is a FIPS 140-2 validated cryptographic engine designed to secure data on servers, workstations, appliances, mobile devices, and in the Cloud.
After making a doctor’s appointment via your mobile device, you receive a calendar invite. The day of your appointment, you get a reminder with the doctor’s location and contact information. As you enter the doctor’s exam room, the medical team is equipped with the latest tablet containing your medical history – he or she makes real time updates to your medical file. At the end of your visit, you receive an electronic prescription to your preferred pharmacy and can schedule your next appointment.
Wearable technology was dominant at this year’s International Consumer Electronics Show (CES) , and MWC was no exception to this trend. New versions of favorites, such as the Samsung Gear (three new products were released: the Gear 2, the Gear 2 Neo and the Gear Fit), shared the limelight with new wearables like Pebble Time Steel (the new premium version of the company’s previously released smartwatch) and the LG Watch Urbane. The most dramatic difference at MWC was an emphasis on presenting wearables as fashion accessories and moving away from the original clunky technology associated with t...
Containers and microservices have become topics of intense interest throughout the cloud developer and enterprise IT communities. Accordingly, attendees at the upcoming 16th Cloud Expo at the Javits Center in New York June 9-11 will find fresh new content in a new track called PaaS | Containers & Microservices Containers are not being considered for the first time by the cloud community, but a current era of re-consideration has pushed them to the top of the cloud agenda. With the launch of Docker's initial release in March of 2013, interest was revved up several notches. Then late last...
The WebRTC Summit 2014 New York, to be held June 9-11, 2015, at the Javits Center in New York, NY, announces that its Call for Papers is open. Topics include all aspects of improving IT delivery by eliminating waste through automated business models leveraging cloud technologies. WebRTC Summit is co-located with 16th International Cloud Expo, @ThingsExpo, Big Data Expo, and DevOps Summit.
SOA Software has changed its name to Akana. With roots in Web Services and SOA Governance, Akana has established itself as a leader in API Management and is expanding into cloud integration as an alternative to the traditional heavyweight enterprise service bus (ESB). The company recently announced that it achieved more than 90% year-over-year growth. As Akana, the company now addresses the evolution and diversification of SOA, unifying security, management, and DevOps across SOA, APIs, microservices, and more.
GENBAND has announced that SageNet is leveraging the Nuvia platform to deliver Unified Communications as a Service (UCaaS) to its large base of retail and enterprise customers. Nuvia’s cloud-based solution provides SageNet’s customers with a full suite of business communications and collaboration tools. Two large national SageNet retail customers have recently signed up to deploy the Nuvia platform and the company will continue to sell the service to new and existing customers. Nuvia’s capabilities include HD voice, video, multimedia messaging, mobility, conferencing, Web collaboration, deskt...
SYS-CON Media announced today that @WebRTCSummit Blog, the largest WebRTC resource in the world, has been launched. @WebRTCSummit Blog offers top articles, news stories, and blog posts from the world's well-known experts and guarantees better exposure for its authors than any other publication. @WebRTCSummit Blog can be bookmarked ▸ Here @WebRTCSummit conference site can be bookmarked ▸ Here
SYS-CON Events announced today that Cisco, the worldwide leader in IT that transforms how people connect, communicate and collaborate, has been named “Gold Sponsor” of SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Cisco makes amazing things happen by connecting the unconnected. Cisco has shaped the future of the Internet by becoming the worldwide leader in transforming how people connect, communicate and collaborate. Cisco and our partners are building the platform for the Internet of Everything by connecting the...
Temasys has announced senior management additions to its team. Joining are David Holloway as Vice President of Commercial and Nadine Yap as Vice President of Product. Over the past 12 months Temasys has doubled in size as it adds new customers and expands the development of its Skylink platform. Skylink leads the charge to move WebRTC, traditionally seen as a desktop, browser based technology, to become a ubiquitous web communications technology on web and mobile, as well as Internet of Things compatible devices.
SYS-CON Events announced today that robomq.io will exhibit at SYS-CON's @ThingsExpo, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. robomq.io is an interoperable and composable platform that connects any device to any application. It helps systems integrators and the solution providers build new and innovative products and service for industries requiring monitoring or intelligence from devices and sensors.
Docker is an excellent platform for organizations interested in running microservices. It offers portability and consistency between development and production environments, quick provisioning times, and a simple way to isolate services. In his session at DevOps Summit at 16th Cloud Expo, Shannon Williams, co-founder of Rancher Labs, will walk through these and other benefits of using Docker to run microservices, and provide an overview of RancherOS, a minimalist distribution of Linux designed expressly to run Docker. He will also discuss Rancher, an orchestration and service discovery platf...
SYS-CON Events announced today that Vitria Technology, Inc. will exhibit at SYS-CON’s @ThingsExpo, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Vitria will showcase the company’s new IoT Analytics Platform through live demonstrations at booth #330. Vitria’s IoT Analytics Platform, fully integrated and powered by an operational intelligence engine, enables customers to rapidly build and operationalize advanced analytics to deliver timely business outcomes for use cases across the industrial, enterprise, and consumer segments.
SYS-CON Events announced today that Solgenia will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY, and the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Solgenia is the global market leader in Cloud Collaboration and Cloud Infrastructure software solutions. Designed to “Bridge the Gap” between Personal and Professional Social, Mobile and Cloud user experiences, our solutions help large and medium-sized organizations dr...
SYS-CON Events announced today that Liaison Technologies, a leading provider of data management and integration cloud services and solutions, has been named "Silver Sponsor" of SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York, NY. Liaison Technologies is a recognized market leader in providing cloud-enabled data integration and data management solutions to break down complex information barriers, enabling enterprises to make smarter decisions, faster.
@ThingsExpo has been named the Top 5 Most Influential M2M Brand by Onalytica in the ‘Machine to Machine: Top 100 Influencers and Brands.' Onalytica analyzed the online debate on M2M by looking at over 85,000 tweets to provide the most influential individuals and brands that drive the discussion. According to Onalytica the "analysis showed a very engaged community with a lot of interactive tweets. The M2M discussion seems to be more fragmented and driven by some of the major brands present in the M2M space. This really allows some room for influential individuals to create more high value inter...
The list of ‘new paradigm’ technologies that now surrounds us appears to be at an all time high. From cloud computing and Big Data analytics to Bring Your Own Device (BYOD) and the Internet of Things (IoT), today we have to deal with what the industry likes to call ‘paradigm shifts’ at every level of IT. This is disruption; of course, we understand that – change is almost always disruptive.
SYS-CON Events announced today that Akana, formerly SOA Software, has been named “Bronze Sponsor” of SYS-CON's 16th International Cloud Expo® New York, which will take place June 9-11, 2015, at the Javits Center in New York City, NY. Akana’s comprehensive suite of API Management, API Security, Integrated SOA Governance, and Cloud Integration solutions helps businesses accelerate digital transformation by securely extending their reach across multiple channels – mobile, cloud and Internet of Things. Akana enables enterprises to share data as APIs, connect and integrate applications, drive part...