London (ots/PRNewswire) -
- Eisai Set to Become an Emerging Leader in the Treatment of
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
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
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
Notes to Editors
(1) Zebinix(R) is the EU trade name for eslicarbazepine
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
@@start.t1@@ - 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@@end@@
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:
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
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
ots Originaltext: Eisai Europe Ltd and Bial
Im Internet recherchierbar: http://www.presseportal.ch
For further information please contact: Andrew Day, EISAI,
+44(0)20-8600-1400, +44(0)7973-411-419; Francisco Osorio, BIAL,