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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• Publié par: eisai-europe-limited
• Nombre de lectures: 29
• Langue: English

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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

]