|By PR Newswire||
|October 2, 2012 07:03 PM EDT||
HATFIELD, England, October 3, 2012 /PRNewswire/ --
Bial and Eisai today present information on new studies designed to increase the understanding of the use of Zebinix® (eslicarbazepine acetate), a once-daily adjunctive therapy for adults with partial-onset seizures, with or without secondary generalisation, at the 10th European Congress on Epileptology (ECE) in London.
These new data will be important as the successful treatment of partial-onset seizures remains a challenge, and up to a third of people with epilepsy do not achieve freedom from seizures despite appropriate therapy with anti-epileptic drugs.
Eslicarbazepine acetate in Partial-Onset Seizures study (EPOS)
Launched in March 2012, the Eslicarbazepine acetate in Partial-Onset Seizures (EPOS) study design presented here aims to provide a better understanding of the use of eslicarbazepine acetate in a clinical practice setting. EPOS is a prospective, multicentre, open-label, non-interventional study of adults with partial-onset seizures insufficiently controlled by monotherapy anti-epileptic treatment. The goal is to recruit approximately 800 patients from over 200 centres in Denmark, France, Germany, Norway, Sweden and the UK. The study primary endpoint will be 6-month retention rate and other assessments will include seizure frequency, adverse events and quality of life.
"The significant number of people with epilepsy who fail to achieve seizure control necessitates the need for on-going investigations in real life settings," commented Martin Holtkamp, EPOS Principal Investigator from the University Hospital Charité, Germany. "Our non-interventional study will increase our knowledge of eslicarbazepine acetate's efficacy and tolerability in routine practice when used to treat adults who are less refractory than those included in standard Phase III adjunctive therapy clinical trials. This will be very valuable information."
Eslicarbazepine acetate is currently licenced as an adjunctive treatment for adults with partial-onset seizures, with or without secondary generalisations (where the seizure extensively affects a patient's consciousness by spreading to both sides of the brain). It is not yet known whether eslicarbazepine acetate will demonstrate efficacy and tolerability if used as a monotherapy and in newly diagnosed patients. To address this question, also presented today is the design of a Phase III, double-dummy, active controlled, multinational non-inferiority monotherapy trial of eslicarbazepine acetate versus controlled-release carbamazepine in adults with partial-onset seizures.
This study will enrol newly diagnosed epilepsy patients ≥18 years of age with documented partial-onset seizures and randomise in a 1:1 ratio.
Paediatric patients sometimes require specific dosing regimens, and additional safety and tolerability evidence beyond that available for adult populations is required. Eslicarbazepine acetate, which does not have a paediatric licence, is currently under investigation in a paediatric patient population for adjunctive use in partial-onset seizures in Europe. The study aims to assess the efficacy and safety of eslicarbazepine acetate as adjunctive therapy in 252 children and adolescents (2 - 18 years old).
There are a further 16 posters presented within this congress, many of which examine the pharmacokinetic and pharmacodynamic information pertaining to eslicarbazepine acetate.
"It is great to see so many studies presented here at the ECE. The abstracts which focus on the pharmacokinetic and pharmacodynamic information will also help doctors build up a much clearer picture of eslicarbazepine acetate," said Professor Eugen Trinka from the Department of Neurology, Paracelsus Medical University, Salzburg, Austria.
Approved in Europe in 2009, Zebinix is currently 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.
*Exclusively by BIAL
Notes to Editors
Zebinix® is the EU trade name for eslicarbazepine acetate
Zebinix® is under license from 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.,,, 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.,,,,,
Over the 12-week maintenance period, Zebinix® 800mg and 1200mg once-daily significantly reduced seizure frequency, and was significantly more effective than placebo.,,, Long-term safety and maintenance of therapeutic effect was demonstrated in one-year open-label extensions of these studies.,,
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 (Headquarters: London, President & CEO: Gary Hendler), a European subsidiary of Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito), 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, Chairman: Luís Portela & CEO: António Portela, "BIAL"), which gave Eisai Europe Limited rights to sell BIAL's anti-epileptic drug Zebinix®(eslicarbazepine acetate) in Europe.
About Eisai Europe 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. Summary of Product Characteristics Zebinix® (eslicarbazepine acetate)(updated November 2011)
2. Kwan P, Brodie MJ. Early identification of refractory epilepsy. New England Journal of Medicine 2000; 342:314-9
3. Holtkamp et al. Design of the EPOS Study. An Open Label Multicentre, Non-Interventional Study to Evaluate Eslicarbazepine Acetate as Adjunctive Treatment to One Baseline Antiepileptic Drud in Adults with Partial Onset seizures. ECE 2012 abstract p665
4. J. Moreira et al. Design of a Phase III, double-dummy, active-controlled, multi-national non-inferiority monotherapy trial of eslicarbazepine acetate versus controlled-release carbamazepine in adults with partial-onset seizures. Abstract ECE 2012 (p415).
5. F. Mota et al. A clinical study method used to evaluate the efficacy and safety of novel antiepileptic drug eslicarbazepine acetate in epileptic children with partial-onset seizures. Abstract ECE 2012 (p175).
6. Epilepsy Research UK. What is Epilepsy? Fact sheet.: http://www.epilepsyresearch.org.uk/about_us/leaflets/lflt1.htm (accessed March 2012)
7. Epilepsy Action. Describing Seizure Types. http://www.epilepsy.org.uk/info/seizures/ataglance (Accessed March 2012)
8. NHS Choices. Symptoms of Epilepsy. http://www.nhs.uk/Conditions/Epilepsy/Pages/Symptoms.aspx (Accessed March 2012)
9. Epilepsy must become a higher priority in Europe. The Lancet Neurology. 2010 Oct; 9(10): 941
10. Pugliatti M et al. Estimating the cost of epilepsy in Europe: A review with economic modelling. Epilepsia 2007: 48(12) 2224 - 2233.
11. Titlic, M. Basic, S. Hajnek, S. Comorbidity psychiatric disorders in epilepsy: a review of literature. Bratisl Lek Listy (Bratislava Medical Journal) 2009; 110 (2): 105 - 109
12. Almeida L, Soares-da-Silva P. Eslicarbazepine acetate (BIA 2-093). Neurotherapeutics. 2007 Jan;4(1):88-96
13. Brady K et al. The effects of Eslicarbazepine, R-Licarbazepine, Oxcarbazepine and Carbamazepine on ion transmission through Cav3.2 channels. Abstract presented at International Epilepsy Congress 2011 p858.
14. Elger et al. Eslicarbazepine Acetate: A Double-blind, Add-on Placebo-controlled Exploratory Trial in Adult Patients with Partial-onset seizures. Epilepsia, 48(3):497-504, 2007
15. Elger C, Halász P, Maia J et al. Efficacy and safety of eslicarbazepine acetate as adjunctive treatment in adults with refractory partial-onset seizures: A randomized, double-blind, placebo-controlled, parallel-group phase III study. Epilepsia 2009; 50(3):454-463
16. Ben-Menachem E, Gabbai A, Hufnagel A, Maia J, Almeida L, Soares-da-Silver P. Eslicarbazepine acetate as adjunctive therapy in adult patients with partial epilepsy; Epilepsy Research 2010;89:278-285.
17. Gil-Nagel A, Lopes-Lima J, Maia J et al. Efficacy and safety of 800 and 1200 mg eslicarbazepine acetate as adjunctive treatment in adults with refractory partial-onset seizures. Acta Neurol Scand 2009: 120: 281-287
18. Halász P, Elger C, Guekht A, et al. Long-term efficacy and safety of eslicarbazepine acetate: Results of a 1-year open-label extension study in partial-onset seizures in adults with epilepsy. Epilepsia, 51(10):1963-1969, 2010
19. Gabbai A, Ben-Menachem E, Maia J, et al. Long-term treatment of partial epilepsy with eslicarbazepine acetate (ESL): results of a one-year open-label extension of study BIA-2093- 302 (Abstract No. 3.208). Epilepsia. 2008;49(Suppl. 7):432-3
20. Lopes-Lima J, Gil-Nagel A, Maia J, et al. Long-term treatment of partial epilepsy with eslicarbazepine acetate (ESL): results of a one-year open-label extension of study BIA-2093-303 (Abstract No. 3.227). Epilepsia. 2008;49(Suppl. 7):441-2.
Date of preparation: September 2012
Job code: Zebinix-UK2255
SYS-CON Events announced today that Enzu, a leading provider of cloud hosting solutions, will exhibit at 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. Enzu’s mission is to be the leading provider of enterprise cloud solutions worldwide. Enzu enables online businesses to use its IT infrastructure to their competitive advantage. By offering a suite of proven hosting and management services, Enzu wants companies to foc...
May. 1, 2016 03:15 PM EDT Reads: 988
So, you bought into the current machine learning craze and went on to collect millions/billions of records from this promising new data source. Now, what do you do with them? Too often, the abundance of data quickly turns into an abundance of problems. How do you extract that "magic essence" from your data without falling into the common pitfalls? In her session at @ThingsExpo, Natalia Ponomareva, Software Engineer at Google, will provide tips on how to be successful in large scale machine lear...
May. 1, 2016 01:45 PM EDT Reads: 1,185
SYS-CON Events announced today that Stratoscale, the software company developing the next generation data center operating system, will exhibit at 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. Stratoscale is revolutionizing the data center with a zero-to-cloud-in-minutes solution. With Stratoscale’s hardware-agnostic, Software Defined Data Center (SDDC) solution to store everything, run anything and scale everywhere...
May. 1, 2016 01:30 PM EDT Reads: 1,557
Digital payments using wearable devices such as smart watches, fitness trackers, and payment wristbands are an increasing area of focus for industry participants, and consumer acceptance from early trials and deployments has encouraged some of the biggest names in technology and banking to continue their push to drive growth in this nascent market. Wearable payment systems may utilize near field communication (NFC), radio frequency identification (RFID), or quick response (QR) codes and barcodes...
May. 1, 2016 01:30 PM EDT Reads: 780
Angular 2 is a complete re-write of the popular framework AngularJS. Programming in Angular 2 is greatly simplified – now it's a component-based well-performing framework. This immersive one-day workshop at 18th Cloud Expo, led by Yakov Fain, a Java Champion and a co-founder of the IT consultancy Farata Systems and the product company SuranceBay, will provide you with everything you wanted to know about Angular 2.
May. 1, 2016 01:00 PM EDT Reads: 1,736
You think you know what’s in your data. But do you? Most organizations are now aware of the business intelligence represented by their data. Data science stands to take this to a level you never thought of – literally. The techniques of data science, when used with the capabilities of Big Data technologies, can make connections you had not yet imagined, helping you discover new insights and ask new questions of your data. In his session at @ThingsExpo, Sarbjit Sarkaria, data science team lead ...
May. 1, 2016 12:45 PM EDT Reads: 774
Unless you don’t use the internet, don’t live in California, or haven’t been paying attention to the recent news… you should be aware that self-driving cars are on their way to becoming a reality. I have seen them – they are real. If you believe in the future reality of self-driving cars, then continue reading on. If you don’t believe in the future possibilities, then I am not sure what to do to convince you other than discuss the very real changes that will roll out with the consumer producti...
May. 1, 2016 12:15 PM EDT Reads: 613
SYS-CON Events announced today that Men & Mice, the leading global provider of DNS, DHCP and IP address management overlay solutions, will exhibit at 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. The Men & Mice Suite overlay solution is already known for its powerful application in heterogeneous operating environments, enabling enterprises to scale without fuss. Building on a solid range of diverse platform support,...
May. 1, 2016 12:15 PM EDT Reads: 2,315
SYS-CON Events announced today that Peak 10, Inc., a national IT infrastructure and cloud services provider, will exhibit at 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. Peak 10 provides reliable, tailored data center and network services, cloud and managed services. Its solutions are designed to scale and adapt to customers’ changing business needs, enabling them to lower costs, improve performance and focus inter...
May. 1, 2016 12:00 PM EDT Reads: 1,110
You deployed your app with the Bluemix PaaS and it's gaining some serious traction, so it's time to make some tweaks. Did you design your application in a way that it can scale in the cloud? Were you even thinking about the cloud when you built the app? If not, chances are your app is going to break. Check out this webcast to learn various techniques for designing applications that will scale successfully in Bluemix, for the confidence you need to take your apps to the next level and beyond.
May. 1, 2016 11:45 AM EDT Reads: 1,485
In the world of DevOps there are ‘known good practices’ – aka ‘patterns’ – and ‘known bad practices’ – aka ‘anti-patterns.' Many of these patterns and anti-patterns have been developed from real world experience, especially by the early adopters of DevOps theory; but many are more feasible in theory than in practice, especially for more recent entrants to the DevOps scene. In this power panel at @DevOpsSummit at 18th Cloud Expo, moderated by DevOps Conference Chair Andi Mann, panelists will dis...
May. 1, 2016 11:00 AM EDT Reads: 631
Whether your IoT service is connecting cars, homes, appliances, wearable, cameras or other devices, one question hangs in the balance – how do you actually make money from this service? The ability to turn your IoT service into profit requires the ability to create a monetization strategy that is flexible, scalable and working for you in real-time. It must be a transparent, smoothly implemented strategy that all stakeholders – from customers to the board – will be able to understand and comprehe...
May. 1, 2016 11:00 AM EDT Reads: 1,085
See storage differently! Storage performance problems have only gotten worse and harder to solve as applications have become largely virtualized and moved to a cloud-based infrastructure. Storage performance in a virtualized environment is not just about IOPS, it is about how well that potential performance is guaranteed to individual VMs for these apps as the number of VMs keep going up real time. In his session at 18th Cloud Expo, Dhiraj Sehgal, in product and marketing at Tintri, will discu...
May. 1, 2016 11:00 AM EDT Reads: 796
In his session at @ThingsExpo, Chris Klein, CEO and Co-founder of Rachio, will discuss next generation communities that are using IoT to create more sustainable, intelligent communities. One example is Sterling Ranch, a 10,000 home development that – with the help of Siemens – will integrate IoT technology into the community to provide residents with energy and water savings as well as intelligent security. Everything from stop lights to sprinkler systems to building infrastructures will run ef...
May. 1, 2016 11:00 AM EDT Reads: 843
SYS-CON Events announced today that SoftLayer, an IBM Company, has been named “Gold Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. SoftLayer, an IBM Company, provides cloud infrastructure as a service from a growing number of data centers and network points of presence around the world. SoftLayer’s customers range from Web startups to global enterprises.
May. 1, 2016 10:15 AM EDT Reads: 961