Burton-on-Trent, UK – 9 September 2013 – Clinigen Group plc (‘Clinigen’ or the ‘Group’) (AIM: CLIN) today announced that it has signed an agreement with Eisai EMEA to exclusively manage an access program for Eisai’s anti-epilepsy drug Fycompa (perampanel) in Germany, ensuring an uninterrupted supply of the drug at no cost to the German healthcare system, following the temporary suspension of commercial distribution in the country.
The access program will be managed by Clinigen GAP (Clinigen Global Access Programs) and will commence when stocks of Fycompa in Germany are exhausted, something which is not expected to happen until the end of December 2013.
Fycompa was developed by Eisai and received Marketing Authorization by the European Commission in July 2012. It is the first and only approved anti-epileptic drug in Europe with a mode of action that selectively targets AMPA receptors, thought to play a role in seizure generation and spread1. Since Fycompa’s launch in September 2012 approximately 3,000 - 4,000 patients in Germany have benefitted from receiving the drug.
Gary Hendler, President and CEO, Eisai EMEA said: “We are pleased to announce our collaboration with Clinigen. Securing a specialist partner to manage the access program for Fycompa has been our highest priority and a critical measure to ensure continuous, uninterrupted supply of the medicine to patients in Germany.”
Peter George, CEO, Clinigen Group said: “We look forward to assisting in the provision of continued access to Fycompa in Germany and are pleased with the confidence entrusted in us by Eisai. As a
specialist provider of global access programs we have the experience and expertise to deliver this bespoke access program within Germany. This program represents the addition of another major pharmaceutical company to our expanding client base.”
1 Rogawski MA. Epilepsy Currents 2011;11:56–63
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About Fycompa (perampanel)
Perampanel is licensed in the European Union (EU) as an adjunctive treatment for people aged 12 years and older with partial-onset seizures, with or without secondarily generalized seizures.
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 characterized by excess neuroexcitatory signaling including epilepsy.
Epilepsy is one of the most common neurological conditions in the world, affecting approximately one in every one hundred 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 characterized 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.
The Clinigen Group is a specialty global pharmaceutical company headquartered in the UK, with offices in the US and Japan. The Group has three operating businesses; Specialty Pharmaceuticals (Clinigen SP), Clinical Trials Supply (Clinigen CTS), and Global Access Programs (Clinigen GAP). Clinigen GAP develops and implements global access programs for biotechnology and pharmaceutical companies and has provided access to unlicensed, licensed and end-of-lifecycle products to thousands of patients.
Eisai is one of the world's leading research and development (R&D) based pharmaceutical companies and it defines its corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which it calls human health care (hhc). 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 regional headquarters and Knowledge Centre in Hatfield, UK, Eisai has recently expanded its business operations to include Europe, the Middle East, Africa, Russia and Oceania (EMEA).
For further information please visit www.eisai.co.uk
Clinigen Group plc
Tel: +44 (0) 1283 495 010
Peter George, Group Chief Executive Officer
Shaun Chilton, Chief Operating Officer
College Hill (media relations)
Tel: +44 (0) 20 7457 2020
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