|By PR Newswire||
|August 3, 2014 07:01 PM EDT||
HATFIELD, England, August 4, 2014 /PRNewswire/ --
PRESS RELEASE FOR EU MEDICAL MEDIA ONLY: NOT FOR SWISS/U.S. JOURNALISTS
Fycompa® (perampanel), the first in an entirely new class of treatment for partial onset seizures (the most common form of epilepsy), launches today in Belgium. The therapy is indicated for the adjunctive treatment of partial onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older.
Perampanel is the only licensed anti-epileptic drug (AED) to selectively target AMPA receptors, a protein in the brain which plays a critical role in the spread of seizures. This mechanism of action is different to other currently available AEDs. In addition, perampanel has the added benefit of convenient, once-daily dosing at bedtime  and, significantly, is the only new-generation partial epilepsy treatment approved to treat adolescents (>12 years) with epilepsy from launch.
Epilepsy is one of the most common neurological conditions in the world. In Belgium, approximately 60,000 people live with epilepsy and 150,000 people will experience an epileptic episode at some point in their life. The successful treatment of partial onset seizures remains a significant challenge in some patients and the incidence of uncontrolled partial epilepsy remains high despite many AEDs. Currently, between 20-40% of patients with newly diagnosed epilepsy will become refractory to treatment.
"We are delighted to announce the launch of perampanel in Belgium. As an emerging leader in the field of epilepsy, Eisai is committed to developing innovative therapies to meet the unmet needs of people with epilepsy who need alternative treatment options to help them achieve seizure control," commented Dr. Nicolas Kormoss, Medical Director for Belgium and Luxemburg at Eisai EMEA.
Perampanel's reimbursement approval in Belgium is based on three randomised, double-blind, placebo-controlled and dose-escalated global pivotal Phase III studies (304, 305, 306),, and an open-label extension study (307). The three global pivotal studies show consistent results in the efficacy and tolerability of perampanel as an adjunctive therapy in people with partial onset seizures, with or without secondary generalisation. The most commonly reported adverse events were dizziness, somnolence, fatigue, headache, falls, irritability and ataxia.,, Results from the open-label extension study also demonstrate perampanel's efficacy and favorable tolerability profile over the longer term.
Discovered and developed by Eisai in Europe and Japan, perampanel is manufactured in the UK and was approved by the European Commission on 23 July 2012.
The launch of perampanel in Belgium 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.
Notes to Editors
About Fycompa® (perampanel)
Perampanel is indicated for the adjunctive treatment of partial onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older.
Perampanel is a highly selective, non-competitive AMPA (alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid)-type glutamate receptor antagonist that has demonstrated seizure reduction in Phase II and III studies. AMPA receptors, widely present in almost all excitatory neurons, transmit signals stimulated by the excitatory neurotransmitter glutamate within the brain and are believed to play a role in central nervous system diseases characterised by excess neuroexcitatory signalling including epilepsy.
For more information please visit: http://www.fycompa.eu
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 causing 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)
- Zonegran® (zonisamide) as monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy and as adjunctive therapy in the treatment of partial seizures, with or without generalisation, in adults, adolescents and children aged six years and above. (Zonegran is under license from the originator Dainippon Sumitomo Pharma). Zonegran is not marketed in Belgium
- Zebinix® (eslicarbazepine acetate) as adjunctive therapy in adult patients with partial onset seizures, with or without secondary generalisation. (Zebinix is under license from BIAL). Zebinix is not marketed in Belgium
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 management
- 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, Iceland, Ireland, Austria, Denmark, Finland, Norway, Portugal, Czech Republic, Slovakia, the Netherlands, Belgium, Luxemburg, Russia and the Middle East.
For further information please visit our web site http://www.eisai.co.uk
1. Fycompa, Summary of Product Characteristics (updated November 2013): http://www.medicines.org.uk/emc/medicine/26951/
2. Rogawski MA. Revisiting AMPA receptors as an antiepileptic drug target. Epilepsy Currents 2011;11:56-63
3. 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 July 2014)
4. Les épilepsies - Statistiques en Belgique. Ligue Francophone Belge contre L'Epilepsie. Available at : http://www.ligueepilepsie.be/spip.php?rubrique33 (Last accessed July 2014)
5. French JA. Refractory Epilepsy; Clinical Overview. Epilepsia 2007: 48 (Suppl1) 3 - 7
6. French JA et al. Adjunctive perampanel for refractory partial-onset seizures: randomized phase III study 304. Neurology 2012:79(6):589-596
7. French JA et al. Evaluation of adjunctive perampanel in patients with refractory partial-onset seizures: Results of randomized global phase III study 305. Epilepsia 2013:54(1):117-125
8. Krauss GM et al. Randomized phase III study 306: Adjunctive perampanel for refractory partial-onset seizures. Neurology 2012:78(18):1408-1415
9. Krauss GL et al. Long-term safety of perampanel and seizure outcomes in refractory partial-onset seizures and secondarily generalised seizures: Results from Phase III extension study 307. Epilepsia 2014; 55: 1058-1068
10. Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe. http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf (Accessed July 2014)
11. 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: July 2014
Job code: Perampanel-UK2173
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. 28, 2017 01:15 AM EST Reads: 2,809
DevOps is often described as a combination of technology and culture. Without both, DevOps isn't complete. However, applying the culture to outdated technology is a recipe for disaster; as response times grow and connections between teams are delayed by technology, the culture will die. A Nutanix Enterprise Cloud has many benefits that provide the needed base for a true DevOps paradigm.
Feb. 27, 2017 11:45 PM EST Reads: 893
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 ...
Feb. 27, 2017 11:00 PM EST Reads: 9,162
Ayehu provides IT Process Automation & Orchestration solutions for IT and Security professionals to identify and resolve critical incidents and enable rapid containment, eradication, and recovery from cyber security breaches. Ayehu provides customers greater control over IT infrastructure through automation. Ayehu solutions have been deployed by major enterprises worldwide, and currently, support thousands of IT processes across the globe. The company has offices in New York, California, and Isr...
Feb. 27, 2017 10:45 PM EST Reads: 805
Tintri VM-aware storage is the simplest for virtualized applications and cloud. Organizations including GE, Toyota, United Healthcare, NASA and 6 of the Fortune 15 have said "No to LUNs." With Tintri they manage only virtual machines, in a fraction of the footprint and at far lower cost than conventional storage. Tintri offers the choice of all-flash or hybrid-flash platform, converged or stand-alone structure and any hypervisor. Rather than obsess with storage, leaders focus on the business app...
Feb. 27, 2017 10:15 PM EST Reads: 710
Addteq is one of the top 10 Platinum Atlassian Experts who specialize in DevOps, custom and continuous integration, automation, plugin development, and consulting for midsize and global firms. Addteq firmly believes that automation is essential for successful software releases. Addteq centers its products and services around this fundamentally unique approach to delivering complete software release management solutions. With a combination of Addteq's services and our extensive list of partners,...
Feb. 27, 2017 10:00 PM EST Reads: 1,300
The Internet of Things will challenge the status quo of how IT and development organizations operate. Or will it? Certainly the fog layer of IoT requires special insights about data ontology, security and transactional integrity. But the developmental challenges are the same: People, Process and Platform and how we integrate our thinking to solve complicated problems. In his session at 19th Cloud Expo, Craig Sproule, CEO of Metavine, demonstrated how to move beyond today's coding paradigm and sh...
Feb. 27, 2017 09:15 PM EST Reads: 4,176
Big Data, cloud, analytics, contextual information, wearable tech, sensors, mobility, and WebRTC: together, these advances have created a perfect storm of technologies that are disrupting and transforming classic communications models and ecosystems. In his session at @ThingsExpo, Erik Perotti, Senior Manager of New Ventures on Plantronics’ Innovation team, provided an overview of this technological shift, including associated business and consumer communications impacts, and opportunities it m...
Feb. 27, 2017 08:00 PM EST Reads: 7,969
For organizations that have amassed large sums of software complexity, taking a microservices approach is the first step toward DevOps and continuous improvement / development. Integrating system-level analysis with microservices makes it easier to change and add functionality to applications at any time without the increase of risk. Before you start big transformation projects or a cloud migration, make sure these changes won’t take down your entire organization.
Feb. 27, 2017 07:45 PM EST Reads: 1,636
WebRTC is about the data channel as much as about video and audio conferencing. However, basically all commercial WebRTC applications have been built with a focus on audio and video. The handling of “data” has been limited to text chat and file download – all other data sharing seems to end with screensharing. What is holding back a more intensive use of peer-to-peer data? In her session at @ThingsExpo, Dr Silvia Pfeiffer, WebRTC Applications Team Lead at National ICT Australia, looked at differ...
Feb. 27, 2017 07:45 PM EST Reads: 7,384
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo 2016 in New York. 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 June 6-8, 2017, at the Javits Center in New York City, New York, is co-located with 20th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry p...
Feb. 27, 2017 07:30 PM EST Reads: 2,269
SYS-CON Events announced today that IoT Now has been named “Media Sponsor” of SYS-CON's 20th International Cloud Expo, which will take place on June 6–8, 2017, at the Javits Center in New York City, NY. IoT Now explores the evolving opportunities and challenges facing CSPs, and it passes on some lessons learned from those who have taken the first steps in next-gen IoT services.
Feb. 27, 2017 07:15 PM EST Reads: 1,999
The Internet of Things can drive efficiency for airlines and airports. In their session at @ThingsExpo, Shyam Varan Nath, Principal Architect with GE, and Sudip Majumder, senior director of development at Oracle, discussed the technical details of the connected airline baggage and related social media solutions. These IoT applications will enhance travelers' journey experience and drive efficiency for the airlines and the airports.
Feb. 27, 2017 07:00 PM EST Reads: 2,610
SYS-CON Events announced today that WineSOFT will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Based in Seoul and Irvine, WineSOFT is an innovative software house focusing on internet infrastructure solutions. The venture started as a bootstrap start-up in 2010 by focusing on making the internet faster and more powerful. WineSOFT’s knowledge is based on the expertise of TCP/IP, VPN, SSL, peer-to-peer, mob...
Feb. 27, 2017 07:00 PM EST Reads: 2,221
DevOps is being widely accepted (if not fully adopted) as essential in enterprise IT. But as Enterprise DevOps gains maturity, expands scope, and increases velocity, the need for data-driven decisions across teams becomes more acute. DevOps teams in any modern business must wrangle the ‘digital exhaust’ from the delivery toolchain, "pervasive" and "cognitive" computing, APIs and services, mobile devices and applications, the Internet of Things, and now even blockchain.
Feb. 27, 2017 06:45 PM EST Reads: 2,270