Eisai's EMEA Operation Becomes the US Supply Centre for Epilepsy Drug Zonegran® (zonisamide)

    Eisai's EMEA Operation Becomes the US Supply Centre for Epilepsy Drug
                            Zonegran® (zonisamide)

  PR Newswire

  HATFIELD, England, October 15, 2013

HATFIELD, England, October 15, 2013 /PRNewswire/ --

Japanese pharmaceutical company Eisai today announces that the US Food and
Drug Administration (FDA) has approved the US supply of the epilepsy drug
Zonegran ^® (zonisamide) from its EMEA (Europe, Middle East, Africa, Russia
and Oceania) Knowledge Centre based in Hatfield, UK. The Hatfield site will
manufacture and package three different strengths of Zonegran tablet for
export to the US.

The FDA supply approval for zonisamide follows the approval for the US supply
of another Eisai epilepsy drug, Fycompa ^® (perampanel), on 11 September 2013.
The manufacturing facility at Hatfield, which also includes Eisai's EMEA sales
and marketing and R&D operations, is increasing in significance to the
company's worldwide business as it continues becomes a global supply centre
for innovative products such as zonisamide and perampanel.

Gary Hendler, President and CEO, Eisai EMEA, comments: "We are pleased to
announce this new FDA approval for the US supply of Zonegran from our Hatfield
manufacturing facility. This latest achievement, which follows the earlier FDA
supply approval for Fycompa, is testament to the commitment our EMEA business
has made to the UK."

Zonisamide was approved in the US in 2000 as adjunctive therapy for the
treatment of partial seizures in adults with epilepsy. ^[ ^1] It is indicated
in Europe 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
secondary generalisation, in adults, adolescents and children aged 6 years and
above. ^[ ^2]

The FDA approval for the manufacture and supply of zonisamide and perampanel
to the US is another example of Eisai's human health care mission; the
company's commitment to increasing access to innovative solutions in disease
prevention, cure and care for the health and well-being of people worldwide.
Eisai is committed to addressing the unmet medical needs of patients and their
families.

Notes to Editors:

Eisai has a long and established history of scientific investment and
partnership in the UK:

  *Eisai's first investments into UK R&D began 20 years ago with a landmark
    partnership with the neurosciences department at University College London
    (UCL), established to undertake world-leading scientific research into
    neurodegenerative diseases. This partnership continues to this day.
  *After entering a new phase in 2011, the company's Neuroscience Product
    Creation Unit (Neuroscience PCU) and UCL are currently engaging in joint
    research into neurodegenerative diseases, including biomarker research and
    drug discovery.
  *Eisai is committed to making further contributions to address key unmet
    medical needs in neurosciences by maintaining and strengthening the
    relationship built up with UCL, whilst at the same time leveraging the
    knowledge accumulated over the course of the partnership for the benefit
    of patients and their families in Europe and beyond.
  *Eisai established the £100 million EMEA Knowledge Centre (EKC), in June
    2009 in Hatfield Hertfordshire. This site integrates the company's
    discovery research, clinical development, production, marketing, and EMEA
    headquarters functions with the aim of expanding business operations
    further in Europe and around the world.
  *In 2012, the Eisai Hatfield site became the first global, solid dose
    manufacture supply site outside of Japan for the antiepilepsy drug Fycompa
    ^® (perampanel).
  *In 2013, it was announced that the Eisai Hatfield site was expanding to
    include an additional high potency, global packaging capability to handle
    the blister packaging of Eisai's investigational treatment lenvatinib
    (E7080). Once fully developed, this site will also increase capacity to
    package and supply the anti-epilepsy drug (AED) Fycompa® (perampanel) and
    other new products, to new markets around the world. 
  *In September 2013 the Eisai Hatfield site was approved by the US Food and
    Drug Administration (FDA) for the supply of epilepsy drug Fycompa ^®
    (perampanel) to the US.
  *In October 2013 the Eisai Hatfield site was approved by the US Food and
    Drug Administration (FDA) for the supply of epilepsy drug Zonegran ^®
    (zonisamide) to the US.

Eisai in Oncology

Our commitment to meaningful progress in oncology research, built on
scientific expertise, is supported by a global capability to conduct discovery
and preclinical research, and develop small molecules, therapeutic vaccines,
and biologic and supportive care agents for cancer across multiple
indications.

About Epilepsy

Epilepsy is one of the most common neurological conditions in the world. ^[3]
There are an estimated six million people who live with epilepsy in Europe,
and an estimated 50 million people with the condition worldwide. Epilepsy is a
chronic disorder of the brain that affects people of all ages. It is
characterised by abnormal discharges of neuronal activity which causes
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:

  *Zonegran ^® (zonisamide) as monotherapy and adjunctive therapy in adults,
    adolescents and children above the age of 6 with partial onset seizures,
    with or without secondary generalisation. (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)
  *Inovelon ^® (rufinamide) for the adjunctive treatment of seizures
    associated with Lennox-Gastaut Syndrome in patients >4 years. (Rufinamide
    was originally developed by Novartis)
  *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

About Eisai

Eisai is one of the world's leading research and development (R&D) based
pharmaceutical companies and 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 human health care ( hhc ).

Eisai concentrates its R&D activities in three key areas:

  *Neuroscience, including: Alzheimer's disease, epilepsy, pain and weight
    loss
  *Oncology including: anticancer therapies; tumour regression, tumour
    suppression, antibodies, etc.
  *Vascular/Immunological reaction including: thrombocytopenia, rheumatoid
    arthritis, psoriasis, inflammatory bowel disease

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 EMEA
Knowledge Centre in Hatfield, UK, Eisai has recently expanded its business
operations to include Europe, the Middle East, Africa, Russia and Oceania
(EMEA). Eisai EMEA has sales and marketing operations in over 20 markets,
including the United Kingdom, France, Germany, Italy, Spain, Switzerland,
Sweden, Ireland, Austria, Denmark, Finland, Norway, Portugal, Czech Republic,
Slovakia, the Netherlands, Belgium, Russia and the Middle East.

For further information please visit our web site http://www.eisai.co.uk



References

1. FDA zonisamide safety label 2012.
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020789s012lbl.pdf
(Accessed September 2013)

2. Eisai Ltd 2013. Zonegran summary of product characteristics (last updated
October 2013)
https://www.medicines.org.uk/emc/history/16240/SPC/Zonegran+25,+50,+100+mg+Hard+Capsules


3. 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 2013 Job code: Corporate-UK2017



Contact: Media Enquiries: Eisai Europe Ltd, Cressida Robson / Charlotte
Andrews, +44(0)7908-314-155/ +44(0)7947-231-513, Cressida_Robson@eisai.net /
Charlotte_Andrews@eisai.net ; Tonic Life Communications: Siobhan Reilly /
Frances Murphy, +44(0)7900605652/+44(0)207-798-9900,
Siobhan.Reilly@toniclc.com / Frances.Murphy@toniclc.com
 
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