Eisai's EMEA Operation Becomes US Supply Centre for Epilepsy Drug Fycompa® (Perampanel)

  Eisai's EMEA Operation Becomes US Supply Centre for Epilepsy Drug Fycompa®

  PR Newswire

  HATFIELD, England, September 11, 2013

HATFIELD, England, September 11, 2013 /PRNewswire/ --

     FDA approval marks Eisai's continued investment in UK high tech drug
                            manufacturing facility

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

The FDA supply approval for perampanel is the latest in a series of
achievements for Eisai in the UK. In addition to its existing EMEA sales and
marketing, R&D, and manufacturing operations in Hatfield, Eisai recently
announced the construction of new 2,900m ^2 facility for the global packaging
of potent compounds which expands the current 7,800m ^2 Hatfield site by
nearly 40%. The Hatfield site is the Eisai EMEA headquarters and is growing in
significance to the company's worldwide business, as it becomes a global
supply centre for innovative new products. Perampanel was jointly developed by
Japan and the UK and, as a result, Eisai continues its commitment to a
long-term global business structure and investment into further research and
development in the UK.

Gary Hendler, President and CEO, Eisai EMEA explains: "The FDA approval for
the supply of our epilepsy drug perampanel is testament to the commitment we
have made at our EMEA Knowledge Centre and the Hatfield manufacturing
facility. The UK is a competitive location for advanced manufacturing and
packaging and I am delighted that we are now able to export products developed
and manufactured here in the UK to the US."

The FDA approval for the manufacture and supply of 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
  *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. 

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

Eisai 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 adult
    patients 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
  *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, Russia, the Netherlands, Belgium, and the Middle East.

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

Date of preparation: September 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,
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