Eisai Enters Russian Market With Approval of First Product

Hatfield, England (ots/PRNewswire) -

Zonegran(R) (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(R) (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(R) (eribulin) and AMPA-type
glutamate receptor antagonist Fycompa(R) (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/imshe
alth/Global/Content/StaticFile/Pharma_Shake-up_Imperatives_3_10.pdf

2. Eisai Ltd. (2005). Zonegran Summary of Product Characteristics
[http://emc.medicines.org.uk ]

ots Originaltext: Eisai Europe Limited
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Media Enquiries: Eisai Europe Ltd, Cressida Robson,
+44-7908-314-155, Cressida_Robson@eisai.net; Tonic Life
Communications,
Benjamyn Tan / Leah Peyton, +44(0)207-798-9262, +44(0)7788-191434,
benjamyn.tan@toniclc.com,
eisaiepilepsy@toniclc.com