Eisai Enters Russian Market With Approval of First Product

Eisai Enters Russian Market With Approval of First Product

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Eisai Enters Russian Market With Approval of First Product PR Newswire HATFIELD, England, June 27, 2012 HATFIELD, England, June 27, 2012 /PRNewswire/ -- ®Zonegran (zonisamide) set to offer new option for epilepsy treatment in Russia Eisai, one of the world's leading research-based pharmaceutical companies, announces the expansion of its operations into Russia, with the approval of its ®first product - the epilepsy treatment, Zonegran (zonisamide). Eisai's entry into the Russian healthcare marketplace is part of the company's plan (HAYABUSA) to have a presence in the top 20 pharmaceutical market regions and make contributions to more than 500 million patients by 2015. The Russian pharmaceuticals market constitutes the 11th largest in the world and is [1]expected to see high growth going forward. Zonisamide is expected to be available across Russia as adjunctive therapy in the treatment of adult epilepsy patients with partial seizures, with or without secondary generalisation by the end of Eisai's financial year 2012 (30 March 2013). The availability of this therapy is significant as the successful treatment of partial-onset seizures (the most common type of epilepsy) remains a challenge. Although new to the Russian marketplace, zonisamide is an established anti- epileptic therapy and has been available in Europe since 2005.

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Eisai Enters Russian Market With Approval of
First Product
PR Newswire
HATFIELD, England, June 27, 2012
HATFIELD,
England
,
June 27, 2012
/PRNewswire/ --
Zonegran
®
(zonisamide) set to offer new option for epilepsy treatment in
Russia
Eisai, one of the world's leading research-based pharmaceutical companies,
announces the expansion of its operations into
Russia
, with the approval of its
first product - the epilepsy treatment, Zonegran
®
(zonisamide).
Eisai's entry into the Russian healthcare marketplace is part of the company's
plan (HAYABUSA) to have a presence in the top 20 pharmaceutical market
regions and make contributions to more than 500 million patients by 2015. The
Russian pharmaceuticals market constitutes the 11th largest in the world and is
expected to see high growth going forward.
[1]
Zonisamide is expected to be available across
Russia
as adjunctive therapy in
the treatment of adult epilepsy patients with partial seizures, with or without
secondary generalisation by the end of Eisai's financial year 2012 (
30 March
2013
). The availability of this therapy is significant as the successful treatment
of partial-onset seizures (the most common type of epilepsy) remains a
challenge.
Although new to the Russian marketplace, zonisamide is an established anti-
epileptic therapy and has been available in
Europe
since 2005. Of note is that
recently the European Medicines Agency's Committee for Medicinal Products
for Human Use (CHMP) issued a positive opinion for extending the use of once-
daily zonisamide as monotherapy for the treatment of partial seizures in adults
with newly diagnosed epilepsy.
"Eisai has been successfully operating in
Europe
for more than 20 years and we
are proud to be increasing access to key medicines in countries outside of this
region," commented Gary Hendler, President and CEO of Eisai's growing
Europe
,
Middle East
and
Africa
(EMEA) business. "We are delighted to announce
the approval of our first product in
Russia
. As further realisation of our mission
to contribute to the health and well being of people worldwide, Zonegran will be
available to people living with epilepsy to aid in the ongoing fight to improve
seizure control in adults with partial seizures, with or without secondary
generalisation."
The continuing development of zonisamide underscores Eisai's human health
care mission, the company's commitment to innovative solutions in disease
prevention, cure and care for the health and well being of people worldwide.
Eisai is committed to the therapeutic area of epilepsy and addressing the
unmet medical needs of patients and their families.
To further demonstrate Eisai's commercial and patient commitment to the
Russian market the company have also submitted marketing authorisation
applications for a number of additional global products including, anticancer
agent Halaven
®
(eribulin) and AMPA-type glutamate receptor antagonist
Fycompa
®
(perampanel).
About Zonegran (zonisamide)
Zonisamide is an antiepileptic drug (AED) originally created by Dainippon
Pharmaceutical Co., Ltd. (currently Dainippon Sumitomo Pharma Co., Ltd.), for
which Eisai holds development, manufacturing and marketing rights in
Russia
as well as in
Europe
,
the United States
and
Asia
.
Zonisamide is a second generation anti-epileptic drug (AED) with multiple
mechanisms of action and a chemical structure unrelated to other AEDs which
means it is unlikely to interact with other drugs. Importantly, it has
pharmacokinetic properties allowing for the clinical advantage of once-daily
dosing. It has a broad spectrum of anti-epileptic modes of action and has no
appreciable effects on steady-state plasma concentrations of other AEDs, such
as phenytoin, carbamazepine and valproate.
[2]
Zonisamide is set to be available in 25mg, 50mg, and 100mg capsule strengths.
The recommended initial daily dose for adjunctive use is 50mg in two divided
doses. After one week the dose may be increased to 100 mg daily and
thereafter the dose may be increased at weekly intervals, in increments of up
to 100 mg.
[2]
About Eisai Europe 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 the European market.
About Eisai
Eisai is one of the world's leading R&D-based pharmaceutical companies and
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 recently expanded their UK Hatfield facility
which now supports the company's growing European, Middle Eastern and
African (EMEA) business.
Eisai concentrates its R&D activities in three key areas:
Neuroscience, including: Alzheimer's disease, multiple sclerosis, neuropathic pain,
epilepsy, depression
Oncology including: anticancer therapies; tumour regression, tumour suppression,
antibodies, etc and supportive cancer therapies; pain relief, nausea
Vascular/Immunological reaction including: acute coronary syndrome, atherothrombotic
disease, rheumatoid arthritis, psoriasis, Crohn's disease
With operations in the U.S.,
Asia
,
Europe
and its domestic home market of
Japan
, Eisai employs more than 11,000 people worldwide. 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
,
Slovakia
,
Slovenia
,
the Netherlands
, and
Belgium
.
For further information please visit our web site http://www.eisai.com
References
1. David Campbell and Mandy Chui. Russian Healthcare
and the Pharmaceutical Industry.
http://www.imshealth.com/deployedfiles/imshealth/Global/Content/StaticFile/Pharma_Shake-
up_Imperatives_3_10.pdf
2. Eisai Ltd. (2005). Zonegran Summary of Product
Characteristics [
http://emc.medicines.org.uk
]