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

Geschrieben am 13-10-2014

Hatfield, Uk (ots/PRNewswire) -

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

Fycompa(R) (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(R) (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(R) (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(R) (rufinamide) for the adjunctive treatment of seizures associated
with Lennox-Gastaut Syndrome in patients >4 years. (Rufinamide was originally
developed by Novartis)
- Zonegran(R) (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(R) (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") 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/Visit
ors/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

ots Originaltext: Eisai Europe Limited
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Media Enquiries: Eisai Europe Ltd, Cressida Robson/Ben Speller,
+44(0)7908 314 155/+44(0)7908 409416, Cressida_Robson@eisai.net,
Ben_Speller@eisai.net; Tonic Life Communications, Frances
Murphy/Nicola
Lilley, +44(0)207 798 9262 /+44 (0)207 798 9905,
frances.murphy@toniclc.com, nicola.lilley@toniclc.com.
Hikma Pharmaceuticals PLC, Ms. Susan Ringdal, VP of Corporate
Strategy and
Investor Relations,
E-mail: susan@hikma.uk.com


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