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Eisai and Bial Announce Partnership Agreement for the European Commercialisation of the Novel Once Daily Anti-Epileptic Zebinix(R)

February 19, 2009

LONDON, February 19 /PRNewswire-FirstCall/ –

– Eisai Set to Become an Emerging Leader in the Treatment of Epilepsy

Eisai Europe Ltd (London; Chairman & CEO Yutaka Tsuchiya), the European
subsidiary of Eisai Co., Ltd. (Tokyo, President & CEO: Haruo Naito), and
Bial-Portela & CA, S.A., (S. Mamede do Coronado, Portugal, CEO Dr Luis
Portela
) today announced the signing of a licence and co-promotion agreement
in which Eisai receives a sole license to market, promote and distribute the
novel once daily anti-epileptic Zebinix(R) (eslicarbazepine acetate), within
Europe(1).

Under the terms of the agreement, Bial will receive EUR95million
consisting of an upfront payment plus milestone payments for further epilepsy
approvals within Europe. Bial will maintain ongoing development and
production rights and the option to co-promote with Eisai throughout Europe
and will supply finished product to Eisai.

Zebinix(R), subject to approval by the European Medicines Agency (EMEA),
will initially be indicated for the adjunctive treatment of partial-onset
seizures, with or without secondary generalisation, in patients 18 years and
older with epilepsy. Zebinix(R) was submitted to the EMEA by Bial in March
2008
and approval is anticipated in Q2 2009.

The safety and efficacy of Zebinix(R) has been shown in three phase III
double-blind, randomised placebo-controlled trials in 1,049 patients with
partial onset seizures. Additionally, these subjects were followed up long
term in an open label extension. In these studies, Zebinix(R) demonstrated
significant sustained improvements in seizure frequency, reduced depressive
symptoms, and significantly improved scores in health related quality of life.

“It is as important to consider the implications on the quality of a
patient’s day-to-day life, as well as effective seizure control, when making
the therapeutic evaluation of a new anti epileptic agent,” said Professor E.
Ben-Menachem
, University of Gothenburg, Sweden. “In addition to sustained
reductions in seizure frequency, Zebinix(R) also demonstrated a significant
improvement in patient quality of life and reduction in depressive symptoms.”

Yutaka Tsuchiya, Chairman & CEO of Eisai Europe said “We are delighted to
be working with Bial to bring to patients such a potentially promising new
treatment for epilepsy. Zebinix(R) joins our existing successful portfolio of
anti-epileptics, which includes Zonegran(R) (zonisamide) and Inovelon(R)
(rufinamide). This helps us to fulfil our Corporate mission of ‘human health
care’ (hhc), to provide innovative, high quality medicines to meet the ever
changing unmet medical needs of the health care profession as well as
patients and their families.”

Commenting on the deal, CEO of Bial, Dr Luis Portela, said “this
partnership with Eisai is a landmark event for Bial in Europe. Zebinix(R)
represents the first results of our R & D efforts in the CNS area. It is the
result of many years of hard work and dedication and we believe Eisai is the
right partner for Bial in Europe, an emerging leader in the field of epilepsy
with the know-how and experience to make Zebinix(R) a leading choice for
patients suffering with Epilepsy.”

Notes to Editors

(1) Zebinix(R) is the EU trade name for eslicarbazepine acetate.

2. European Territories

Austria, Belgium, Bulgaria, Czech Republic, Belarus, Bosnia, Croatia,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Monaco,
Netherlands, Norway, Poland, Romania, Russia, Serbia, Slovakia, Slovenia,
Spain (co promotion with Bial from launch) Sweden, Switzerland, Turkey,
Ukraine and United Kingdom.

3. About epilepsy

Epilepsy is a chronic neurological disease characterised by abnormal
discharges of neuronal activity causing seizures. Clinically, these manifest
as convulsions or jerking of muscles. Depending on the seizure type, seizures
may be limited to one part of the body, or may be generalised to involve the
whole body. Patients may also experience abnormal sensations, altered
behaviour or altered consciousness. Epilepsy is a disorder with many possible
causes. Often the cause of epilepsy is unknown. However, anything that
disturbs the normal pattern of neuron activity – from illness to brain damage
to abnormal brain development, can lead to seizures.

4. About Zebinix

Zebinix(R) (eslicarbazepine acetate), is a novel voltage gated sodium
channel blocker. It specifically targets the inactivated state of the ion
channel, preventing its return to the active state, and thereby reduces
repetitive neuronal firing. The efficacy of Zebinix(R) has been demonstrated
in 3 randomized, placebo controlled studies in 1049 patients with refractory
partial onset seizures. Zebinix(R) also significantly improved patient’s
health related quality of life (HRQoL) as measured by the QOLIE-31 score
during a one year open label extension of the above 3 studies. Zebinix(R) is
given orally once daily. Zebinix(R) can be used as an add-on to carbamazepine
(one of the most commonly utilized therapies for partial onset seizures) or
with other anti-epileptics.

5. About Eisai

Eisai is one of the worlds leading R&D-based pharmaceutical companies,
that has defined its 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

    - Integrative Neuroscience: Alzheimer's disease, multiple
      sclerosis, neuropathic pain, epilepsy, depression, etc

    - Integrative Oncology: Anticancer therapies; tumour regression,
      tumour suppression, antibodies, etc and Supportive cancer therapies;
      pain relief, nausea, etc

    - Vascular/Immunological Reaction: Acute coronary syndrome,
      atherothrombotic disease, sepsis, rheumatoid arthritis, psoriasis,
      Crohn's disease, etc

With operations in the U.S., Asia, Europe and its domestic home market of
Japan, we employ more than 10,000 people worldwide, and reported consolidated
sales of over GBP3.53 billion in FY2007, an increase of 8.9% year on year. In
Europe, Eisai undertakes sales and marketing operations in over 20 markets,
including the United Kingdom, France, Germany, Italy, Spain, Switzerland,
Sweden, Ireland, Austria, Denmark, Finland, Norway, Portugal, Iceland, Czech
Republic
, Hungary, and Slovakia.

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

6. About Bial

Founded in 1924, Bial is an international pharmaceutical group with
products available in over 30 countries throughout four continents. BIAL is
the largest Portuguese pharmaceutical company and is based in S. Mamede do
Coronado, Portugal.

It is the partner of choice for many companies, having a strong presence
in the Iberian peninsula as well as in over 10 countries in Latin America and
in around 20 French or Portuguese speaking African countries.

Bial is strongly committed to therapeutic innovation investing
approximately 20% of its turnover in research and development every year. Key
research areas for BIAL are the central nervous system, the cardiovascular
system and allergology. Bial currently has several other innovative programs
under development, which the company expects to bring to the market within
the next years, thereby strengthening its position throughout Europe.

Further information about Bial can be found at http://www.bial.com

SOURCE Eisai Europe Ltd and Bial


Source: newswire



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