Eisai Enters Russian Market With Approval of First Product

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 ]