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