|By JCN Newswire||
|May 12, 2014 03:26 AM EDT||
In Germany approximately 3,000 and 4,000 people with epilepsy have been treated with Fycompa since its launch in September 2012. Eisai temporarily suspended Fycompa from distribution in Germany following the previous negative G-BA ruling in March 2013 and established a patient access program for continued supply of Fycompa free of charge to German pharmacies through individual import to ensure that people with epilepsy continue to receive treatment with Fycompa, while the G-BA considers the resubmission.
In Germany, approximately one in every 200 people has epilepsy, which equates to an estimated 400,000 people in the country who live with the condition. The successful treatment of partial-onset seizures remains a challenge as over 30% of patients do not achieve adequate seizure control despite appropriate therapy with existing AEDs, and there continues to be a pressing need for innovative new treatments. Fycompa was approved in over 35 countries in Europe, North America and Asia as an adjunctive treatment for partial-onset seizures (including secondarily generalized seizures) in patients with epilepsy aged 12 years and older.
Eisai believes that through this reassessment of additional benefit, Fycompa will be recognized appropriately for its benefits as well as being an innovative new treatment, and that sales of the drug will be resumed in Germany, ensuring delivery to patients with partial-onset seizures.
1. About Fycompa (Perampanel)
Fycompa (perampanel), a novel chemical entity discovered and developed by Eisai, is a noncompetitive AMPA-type glutamate receptor antagonist. Fycompa is the first AED to reduce neuronal hyperexcitation associated with seizures by targeting glutamate activity at postsynaptic AMPA receptors and has demonstrated its antiseizure effects in Phase II and III studies. The agent is currently approved in more than 35 countries and territories, including in Europe and the United States, as a treatment (once-daily oral dose) of partial-onset seizures and is also being evaluated in a Phase III study in Asia, including in Japan. Furthermore, Eisai is conducting a global Phase III perampanel study for generalized epilepsy and Phase II perampanel studies in Europe and the United States for partial-onset epilepsy in pediatric patients, as it seeks to expand the range of indications for which the drug is approved.
2. Glossary of Terms
1) German Federal Joint Committee (G-BA)
The German Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) is the highest decision-making body of the joint self-government of physicians, dentists, hospitals and health insurance funds in Germany. It issues directives for the benefit catalog of statutory health insurance funds (GKV) and thus specifies which drugs and medical services are reimbursed by the GKV.
2) About additional benefit assessment conducted by the G-BA
In Germany, the enactment of the Act on the Reform of the Market for Medical Products (Arzneimittelmarkt-Neuordnungsgesetz, AMNOG) came into effect on January 2011. Under this amendment, all eligible new drugs launched on the German market must undergo an additional benefit assessment conducted by the G-BA, with later price negotiations to be based on this assessment and a reimbursement price to be decided within one year from the drug's launch.
Furthermore, when a new drug is launched, the pharmaceutical company must submit to the G-BA a benefit dossier demonstrating the drug's additional benefit over a comparator. The G-BA then usually commissions the country's Institute for Quality and Efficiency in Health Care (IQWiG) to evaluate the dossier to decide whether any additional benefit exists over the comparator and the results are subsequently published. The pharmaceutical company is next given an opportunity to comment at a hearing on the IQWiG's evaluation, after which the G-BAcarries out its final decision regarding any additional benefit of the drug.
If an additional benefit is recognized by the G-BA, the drug proceeds to the price negotiation stage with the lead association of the German sick funds (GKV-SV), and a reimbursement price is decided based on the level of additional benefit as decided by the G-BA. On the other hand, a drug deemed to offer no recognized additional benefit is designated a reference price group as well as a reimbursement price based on the price of the comparator used during the benefit assessment.
Eisai Co., Ltd. (TSE: 4523; ADR: ESALY) is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three therapeutic areas: integrative neuroscience, including neurology and psychiatric medicines; integrative oncology, which encompasses oncotherapy and supportive-care treatments; and vascular/immunological reaction. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide healthcare system. For more information about Eisai Co., Ltd., please visit www.eisai.com.
Public Relations Department, Eisai Co., Ltd. +81-3-3817-5120
Copyright 2014 JCN Newswire. All rights reserved. www.japancorp.net
We are reaching the end of the beginning with WebRTC, and real systems using this technology have begun to appear. One challenge that faces every WebRTC deployment (in some form or another) is identity management. For example, if you have an existing service – possibly built on a variety of different PaaS/SaaS offerings – and you want to add real-time communications you are faced with a challenge relating to user management, authentication, authorization, and validation. Service providers will w...
Dec. 28, 2014 06:00 PM EST Reads: 2,023
The term culture has had a polarizing effect among DevOps supporters. Some propose that culture change is critical for success with DevOps, but are remiss to define culture. Some talk about a DevOps culture but then reference activities that could lead to culture change and there are those that talk about culture change as a set of behaviors that need to be adopted by those in IT. There is no question that businesses successful in adopting a DevOps mindset have seen departmental culture change, ...
Dec. 28, 2014 05:45 PM EST Reads: 1,781
There's Big Data, then there's really Big Data from the Internet of Things. IoT is evolving to include many data possibilities like new types of event, log and network data. The volumes are enormous, generating tens of billions of logs per day, which raise data challenges. Early IoT deployments are relying heavily on both the cloud and managed service providers to navigate these challenges. In her session at Big Data Expo®, Hannah Smalltree, Director at Treasure Data, discussed how IoT, Big D...
Dec. 28, 2014 05:00 PM EST Reads: 2,285
The Internet of Things is tied together with a thin strand that is known as time. Coincidentally, at the core of nearly all data analytics is a timestamp. When working with time series data there are a few core principles that everyone should consider, especially across datasets where time is the common boundary. In his session at Internet of @ThingsExpo, Jim Scott, Director of Enterprise Strategy & Architecture at MapR Technologies, discussed single-value, geo-spatial, and log time series dat...
Dec. 28, 2014 05:00 PM EST Reads: 2,287
The Internet of Things promises to transform businesses (and lives), but navigating the business and technical path to success can be difficult to understand. In his session at @ThingsExpo, Sean Lorenz, Technical Product Manager for Xively at LogMeIn, demonstrated how to approach creating broadly successful connected customer solutions using real world business transformation studies including New England BioLabs and more.
Dec. 28, 2014 04:00 PM EST Reads: 2,150
The security devil is always in the details of the attack: the ones you've endured, the ones you prepare yourself to fend off, and the ones that, you fear, will catch you completely unaware and defenseless. The Internet of Things (IoT) is nothing if not an endless proliferation of details. It's the vision of a world in which continuous Internet connectivity and addressability is embedded into a growing range of human artifacts, into the natural world, and even into our smartphones, appliances, a...
Dec. 28, 2014 03:30 PM EST Reads: 2,600
Fundamentally, SDN is still mostly about network plumbing. While plumbing may be useful to tinker with, what you can do with your plumbing is far more intriguing. A rigid interpretation of SDN confines it to Layers 2 and 3, and that's reasonable. But SDN opens opportunities for novel constructions in Layers 4 to 7 that solve real operational problems in data centers. "Data center," in fact, might become anachronistic - data is everywhere, constantly on the move, seemingly always overflowing. Net...
Dec. 28, 2014 03:00 PM EST Reads: 2,177
The Internet of Things will put IT to its ultimate test by creating infinite new opportunities to digitize products and services, generate and analyze new data to improve customer satisfaction, and discover new ways to gain a competitive advantage across nearly every industry. In order to help corporate business units to capitalize on the rapidly evolving IoT opportunities, IT must stand up to a new set of challenges. In his session at @ThingsExpo, Jeff Kaplan, Managing Director of THINKstrateg...
Dec. 28, 2014 03:00 PM EST Reads: 1,848
DevOps Summit 2015 New York, co-located with the 16th International Cloud Expo - to be held June 9-11, 2015, at the Javits Center in New York City, NY - announces that it is now accepting Keynote Proposals. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long development cycles that produce software that is obsolete...
Dec. 28, 2014 02:00 PM EST Reads: 1,846
WebRTC defines no default signaling protocol, causing fragmentation between WebRTC silos. SIP and XMPP provide possibilities, but come with considerable complexity and are not designed for use in a web environment. In his session at @ThingsExpo, Matthew Hodgson, technical co-founder of the Matrix.org, discussed how Matrix is a new non-profit Open Source Project that defines both a new HTTP-based standard for VoIP & IM signaling and provides reference implementations.
Dec. 28, 2014 12:30 PM EST Reads: 2,002
"There is a natural synchronization between the business models, the IoT is there to support ,” explained Brendan O'Brien, Co-founder and Chief Architect of Aria Systems, in this SYS-CON.tv interview at the 15th International Cloud Expo®, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 28, 2014 12:00 PM EST Reads: 2,940
SYS-CON Events announced today Isomorphic Software, the global leader in high-end, web-based business applications, will exhibit at SYS-CON's DevOps Summit 2015 New York, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Isomorphic Software is the global leader in high-end, web-based business applications. We develop, market, and support the SmartClient & Smart GWT HTML5/Ajax platform, combining the productivity and performance of traditional desktop software ...
Dec. 28, 2014 12:00 PM EST Reads: 1,893
The definition of IoT is not new, in fact it’s been around for over a decade. What has changed is the public's awareness that the technology we use on a daily basis has caught up on the vision of an always on, always connected world. If you look into the details of what comprises the IoT, you’ll see that it includes everything from cloud computing, Big Data analytics, “Things,” Web communication, applications, network, storage, etc. It is essentially including everything connected online from ha...
Dec. 28, 2014 12:00 PM EST Reads: 2,431
The 3rd International Internet of @ThingsExpo, co-located with the 16th International Cloud Expo - to be held June 9-11, 2015, at the Javits Center in New York City, NY - announces that its Call for Papers is now open. The Internet of Things (IoT) is the biggest idea since the creation of the Worldwide Web more than 20 years ago.
Dec. 28, 2014 12:00 PM EST Reads: 7,205
Connected devices and the Internet of Things are getting significant momentum in 2014. In his session at Internet of @ThingsExpo, Jim Hunter, Chief Scientist & Technology Evangelist at Greenwave Systems, examined three key elements that together will drive mass adoption of the IoT before the end of 2015. The first element is the recent advent of robust open source protocols (like AllJoyn and WebRTC) that facilitate M2M communication. The second is broad availability of flexible, cost-effective ...
Dec. 28, 2014 11:00 AM EST Reads: 2,058