Eisai Names Partner For Pan Middle East Distribution of First-in-class Epilepsy Treatment Fycompa® (perampanel)

HATFIELD, UK, October 13, 2014 /PRNewswire/ --

PRESS RELEASE FOR EU MEDIA ONLY: NOT FOR SWISS/U.S. JOURNALISTS 

Fycompa^® (perampanel), Eisai's first-in-class epilepsy treatment, will be made available throughout the Middle East through a partnership with Hikma Pharmaceuticals PLC. The partnership will commence immediately, with perampanel launches throughout the region expected to follow in 2015. In the EU, 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.^[1]

"We are very pleased to announce the partnership with Hikma, who is well positioned to help us ensure that people throughout the Middle East will soon be able to access our innovative epilepsy treatment Fycompa," commented Gary Hendler, President & CEO, Eisai EMEA.

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.^[2] 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.^[1]

"We are committed to our partnership with Eisai, which supports our strategy of working with global partners to strengthen our product portfolio in growing therapeutic areas and to bring important treatment options to patients in the Middle East region," commented Mazen Darwazah, Hikma Pharmaceutical's Executive Vice Chairman and President and CEO of MENA and Emerging Markets.

Epilepsy is one of the most common neurological conditions in the world.^[3] 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, up to 40% of patients with newly diagnosed epilepsy will become refractory to treatment.^[4]

Countries covered by the partnership will include the Kingdom of Saudi Arabia, United Arab Emirates, Jordan, Kuwait, Bahrain, Oman, Qatar, Sudan, Iraq, Libya and Yemen. Perampanel was approved by the European Commission on 23 July 2012 and the United States Federal Drug Administration (FDA) on 22 October 2012. Discovered and developed by Eisai in Europe and Japan, perampanel is manufactured in the UK.

The partnership 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. Eisai is committed to the therapeutic area of epilepsy and to address the unmet medical needs of people with epilepsy and their families.

Notes to Editors 

About Fycompa^® (perampanel) 

In the EU, 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.^[1]

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.^[1]

For more information please visit: http://www.fycompa.eu

About Epilepsy  

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.^[5],[6]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)
• Zebinix^® (eslicarbazepine acetate) as adjunctive therapy in adult patients with partial onset seizures, with or without secondary generalisation. (Zebinix is under license from BIAL)

About Eisai Co., Ltd. 

Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. 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 our human health care (hhc) philosophy. With over 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realise our hhc philosophy by delivering innovative products in various therapeutic areas with high unmet medical needs, including Oncology and Neurology. 

As a global pharmaceutical company, our mission extends to patients around the world through our investment and participation in partnership-based initiatives to improve access to medicines in developing and emerging countries.

For more information about Eisai Co., Ltd., please visit http://www.eisai.com

About Hikma Pharmaceuticals PLC 

Hikma Pharmaceuticals PLC ("Hikma") (LSE: HIK) (NASDAQ Dubai: HIK) is a fast growing multinational pharmaceutical group which was founded in 1978 in Jordan. Hikma develops, manufactures and markets a broad range of both branded and non-branded generic and in-licensed products. Hikma is committed to the highest quality manufacturing with multiple FDA approved facilities Hikma operates in the US, Europe and across the MENA region.

For more information about Hikma Pharmaceuticals PLC, please visit http://www.hikma.com

References  

1. Fycompa, Summary of Product Characteristics (updated September 2014): 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 September 2014)  

4. French JA. Refractory Epilepsy; Clinical Overview. Epilepsia 2007: 48 (Suppl1) 3-7 

5. Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe. http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf (Accessed September 2014)6. 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: October 2014
Job code: Perampanel-UK2176