|By PR Newswire||
|February 2, 2014 07:01 PM EST||
HATFIELD, England, February 3, 2014 /PRNewswire/ --
Eisai announces today that Zebinix® (eslicarbazepine acetate), a novel anti-epilepsy treatment, has received full reimbursement from the Finnish Health Authorities. Once-daily eslicarbazepine acetate, is indicated as adjunctive therapy in adults with partial onset seizures, with or without secondary generalisation.
"Up to a third of people with epilepsy do not achieve adequate seizure control after their first anti-epileptic treatment so there is a continued need for additional effective options. Eslicarbazepine acetate will provide doctors with a new, easy to titrate, adjunctive therapy to help those with inadequately controlled partial onset epilepsy improve their condition," commented Dr. Jukka Peltola, Tampere University Hospital.
Epilepsy is one of the most common neurological conditions in the world and affects approximately 56,000 people in Finland., Despite many anti-epileptic drugs (AEDs) available, the successful treatment of partial onset seizures remains a significant challenge in some patients. Currently, between 20-40% of patients with newly diagnosed epilepsy will become refractory to treatment.
Eslicarbazepine acetate, a third generation sodium channel blocker that differentially and selectively targets slow inactivated sodium channels, was approved by the European Commission in 2009 based on data submitted which showed that it reduces seizure frequency by up to 45% in patients with partial epilepsy.,, Long-term studies also show that up to 18% of patients achieved seizure freedom with eslicarbazepine acetate,,, while a real-world, retrospective, multicentre audit (n=202) show up to 19.8% of patients achieved seizure freedom with the AED. A long-term open-label extension study demonstrated a statistically significant improvement in quality of life from baseline, including seizure worry, energy/fatigue, medication effects and cognitive and social function.
Dr. Sten Friberg, Nordic Medical Director for Eisai AB commented: "We are delighted that Zebinix has received 100% reimbursement status in Finland and will provide an effective and well tolerated alternative treatment to help people with epilepsy manage their seizures. Eisai is committed to bringing effective treatments such as this to patients to help improve their quality of life, as underscored by our human health care mission."
The launch of eslicarbazepine acetate in Finland underscores Eisai's human health care (hhc) mission, the company's commitment to innovative solutions in disease prevention, cure and care for the health and wellbeing of people worldwide. Eslicarbazepine acetate 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 eslicarbazepine acetate) and Wales.
*Exclusively by BIAL
Notes to Editors
Zebinix® is the EU trade name for eslicarbazepine acetate
Zebinix® is under license from BIAL
About Zebinix®(eslicarbazepine acetate)
Eslicarbazepine acetate is a voltage-gated sodium channel blocker. It selectively targets the slow inactivated state of the sodium ion channel, (which have been implicated in the pathogenesis of epilepsy), preventing its return to the active state, and thereby reduces repetitive neuronal firing. Further, eslicarbazepine acetate does not inhibit potassium efflux, which may reduce the potential for repetitive neuronal firings. 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.,,
For more information please visit: http://www.eisai.co.uk
Epilepsy is one of the most common neurological conditions in the world, affecting approximately eight in 1,000 people in Europe, and an estimated 50 million people worldwide., Epilepsy is a chronic disorder of the brain that affects people of all ages. It is characterised by abnormal discharges of neuronal activity which causes seizures. Seizures can vary in severity, from brief lapses of attention or jerking of muscles, to severe and prolonged convulsions. Depending on the seizure type, seizures may be limited to one part of the body, or may involve the whole body. Seizures can also vary in frequency from less than one per year, to several per day. Epilepsy has many possible causes but often the cause is unknown.
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, Russia and Oceania (EMEA).
In the EMEA region, Eisai currently has four marketed treatments including:
- 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
- Inovelon® (rufinamide) for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in patients >4 years. (Rufinamide was originally developed by Novartis)
- Zebinix® (eslicarbazepine acetate) as adjunctive therapy in adult patients with partial onset seizures, with or without secondary generalisation. (Zebinix is under license from BIAL)
- Zonegran® (zonisamide) as monotherapy in adults and adjunctive therapy in adults, adolescents and children aged six years and above with partial onset seizures, with or without secondary generalisation. (Zonegran is under license from the originator Dainippon Sumitomo Pharma)
Eisai is one of the world's leading research and development (R&D) based pharmaceutical companies and we define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call human health care (hhc).
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 10,000 people worldwide. From its EMEA Knowledge Centre in Hatfield, UK, Eisai has recently expanded its business operations to include Europe, the Middle East, Africa, Russia and Oceania (EMEA). Eisai EMEA has sales and marketing operations in over 20 markets, including the United Kingdom, France, Germany, Italy, Spain, Switzerland, Sweden, Ireland, Austria, Denmark, Finland, Norway, Portugal, Czech Republic, Slovakia, the Netherlands, Belgium, Russia and the Middle East.
For further information please visit our web site http://www.eisai.co.uk
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 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. Eisai Ltd 2013. Zebinix® (eslicarbazepine acetate) summary of product characteristics (last updated April 2013): http://www.medicines.org.uk/emc/medicine/22376/SPC/Zebinix+800mg+tablets/
2. ILAE/IBE/WHO, Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe 2010. Available at; http://www.ilae.org/Visitors/Documents/ILAEAnnual-Report2010Final_000.pdf (Accessed December 2013)
3. Finnish Epilepsy Association (FEA) http://www.epilepsia.fi/epilepsialiitto/in_english (Accessed December 2013)
4. French JA. Refractory Epilepsy; Clinical Overview. Epilepsia 2007: 48 (Suppl1) 3 - 7
5. Elger C 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.
6. Ben-Menachem E et al. Eslicarbazepine acetate as adjunctive therapy in adult patients with partial epilepsy; Epilepsy Research 2010;89:278-285.
7. Gil-Nagel A 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.
8. Hufnagel A et al. Long-term safety and efficacy of eslicarbazepine acetate as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy: results of a 1-year open-label extension study. Epilepsy Res. 2013 Feb;103(2-3):262-9
9. Halász P 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.
10. Lopes-Lima 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. Epilepsia 2008; 49(Supplement 7) 441 Abstract 3.227.4
11. Keogh S, et al. Safety and efficacy of eslicarbazepine acetate (Zebinix) in everyday clinical practice using a retrospective multicentre audit. ILAE UK Poster. 2013; 34.
12. Halász P 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.
13. Almeida L, Soares-da-Silva P. Eslicarbazepine Acetate (BIA 2-093). Neurotherapeutics. 2007 Jan;4(1):88-96
14. Elger C et al. Pharmacokinetics and tolerability of eslicarbazepine acetate and oxcarbazepine at steady state in healthy volunteers. Epilepsia 2013; 54(8): 1453-1461.
15. Hebeisen S et al. The effects of eslicarbazepine and R-licarbazepine on sodium currents through Nav1.7 and
Nav1.8 channels. Epilepsia 2012; 53 (Suppl. 5): 1-245.
16. Vilin YY and Ruben PC. Slow Inactivation in Voltage-Gated Sodium Channels. Cell Biochem Biophys 2001; 35(2):171-190.
17. Elger et al. Eslicarbazepine Acetate: A Double-blind, Add-on, Placebo-controlled Exploratory Trial in Adult Patients with Partial-onset Seizures. Epilepsia 2007; 48(3):497-504
18. Soares-da-silva et al. Assessment of Quality-Of-Life and Depressive Symptoms During Long-Term Treatment with Eslicarbazepine Acetate: BIA-2093-302 Study. Epilepsia 2011; 52(Suppl. 6):23-263
19. Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe. http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf (Accessed December 2013)
20. Pugliatti M, et al. Estimating the cost of epilepsy in Europe: A review with economic modeling. Epilepsia 2007; 48(12) 2224-2233.
Date of preparation: February 2014
Job code: Zebinix-UK2302
Data is the fuel that drives the machine learning algorithmic engines and ultimately provides the business value. In his session at 20th Cloud Expo, Ed Featherston, director/senior enterprise architect at Collaborative Consulting, will discuss the key considerations around quality, volume, timeliness, and pedigree that must be dealt with in order to properly fuel that engine.
Feb. 24, 2017 04:00 AM EST Reads: 3,787
SYS-CON Events announced today that DatacenterDynamics has been named “Media 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. DatacenterDynamics is a brand of DCD Group, a global B2B media and publishing company that develops products to help senior professionals in the world's most ICT dependent organizations make risk-based infrastructure and capacity decisions.
Feb. 24, 2017 03:00 AM EST Reads: 1,815
"Matrix is an ambitious open standard and implementation that's set up to break down the fragmentation problems that exist in IP messaging and VoIP communication," explained John Woolf, Technical Evangelist at Matrix, in this SYS-CON.tv interview at @ThingsExpo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Feb. 24, 2017 02:15 AM EST Reads: 13,195
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 Ca...
Feb. 24, 2017 01:45 AM EST Reads: 9,537
As software becomes more and more complex, we, as software developers, have been splitting up our code into smaller and smaller components. This is also true for the environment in which we run our code: going from bare metal, to VMs to the modern-day Cloud Native world of containers, schedulers and micro services. While we have figured out how to run containerized applications in the cloud using schedulers, we've yet to come up with a good solution to bridge the gap between getting your contain...
Feb. 24, 2017 01:45 AM EST Reads: 3,773
"We host and fully manage cloud data services, whether we store, the data, move the data, or run analytics on the data," stated Kamal Shannak, Senior Development Manager, Cloud Data Services, IBM, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Feb. 24, 2017 01:30 AM EST Reads: 5,730
Information technology (IT) advances are transforming the way we innovate in business, thereby disrupting the old guard and their predictable status-quo. It’s creating global market turbulence. Industries are converging, and new opportunities and threats are emerging, like never before. So, how are savvy chief information officers (CIOs) leading this transition? Back in 2015, the IBM Institute for Business Value conducted a market study that included the findings from over 1,800 CIO interviews ...
Feb. 24, 2017 01:15 AM EST Reads: 1,896
All organizations that did not originate this moment have a pre-existing culture as well as legacy technology and processes that can be more or less amenable to DevOps implementation. That organizational culture is influenced by the personalities and management styles of Executive Management, the wider culture in which the organization is situated, and the personalities of key team members at all levels of the organization. This culture and entrenched interests usually throw a wrench in the work...
Feb. 24, 2017 01:00 AM EST Reads: 2,534
IoT is at the core or many Digital Transformation initiatives with the goal of re-inventing a company's business model. We all agree that collecting relevant IoT data will result in massive amounts of data needing to be stored. However, with the rapid development of IoT devices and ongoing business model transformation, we are not able to predict the volume and growth of IoT data. And with the lack of IoT history, traditional methods of IT and infrastructure planning based on the past do not app...
Feb. 24, 2017 01:00 AM EST Reads: 1,893
Niagara Networks exhibited at the 19th International Cloud Expo, which took place at the Santa Clara Convention Center in Santa Clara, CA, in November 2016. Niagara Networks offers the highest port-density systems, and the most complete Next-Generation Network Visibility systems including Network Packet Brokers, Bypass Switches, and Network TAPs.
Feb. 24, 2017 12:45 AM EST Reads: 969
WebRTC services have already permeated corporate communications in the form of videoconferencing solutions. However, WebRTC has the potential of going beyond and catalyzing a new class of services providing more than calls with capabilities such as mass-scale real-time media broadcasting, enriched and augmented video, person-to-machine and machine-to-machine communications. In his session at @ThingsExpo, Luis Lopez, CEO of Kurento, introduced the technologies required for implementing these idea...
Feb. 23, 2017 11:30 PM EST Reads: 6,298
Why do your mobile transformations need to happen today? Mobile is the strategy that enterprise transformation centers on to drive customer engagement. In his general session at @ThingsExpo, Roger Woods, Director, Mobile Product & Strategy – Adobe Marketing Cloud, covered key IoT and mobile trends that are forcing mobile transformation, key components of a solid mobile strategy and explored how brands are effectively driving mobile change throughout the enterprise.
Feb. 23, 2017 11:00 PM EST Reads: 7,020
Apache Hadoop is emerging as a distributed platform for handling large and fast incoming streams of data. Predictive maintenance, supply chain optimization, and Internet-of-Things analysis are examples where Hadoop provides the scalable storage, processing, and analytics platform to gain meaningful insights from granular data that is typically only valuable from a large-scale, aggregate view. One architecture useful for capturing and analyzing streaming data is the Lambda Architecture, represent...
Feb. 23, 2017 10:00 PM EST Reads: 4,608
SYS-CON Events announced today that delaPlex will exhibit at SYS-CON's @CloudExpo, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. delaPlex pioneered Software Development as a Service (SDaaS), which provides scalable resources to build, test, and deploy software. It’s a fast and more reliable way to develop a new product or expand your in-house team.
Feb. 23, 2017 09:15 PM EST Reads: 1,528
The explosion of new web/cloud/IoT-based applications and the data they generate are transforming our world right before our eyes. In this rush to adopt these new technologies, organizations are often ignoring fundamental questions concerning who owns the data and failing to ask for permission to conduct invasive surveillance of their customers. Organizations that are not transparent about how their systems gather data telemetry without offering shared data ownership risk product rejection, regu...
Feb. 23, 2017 08:45 PM EST Reads: 1,298