Eisai to Present New Clinical Research on Zonegran(R) at the International Epilepsy Congress

HATFIELD, England, August 25, 2011 /PRNewswire/ --

Eisai announced today, that for the first time, it is presenting the results of two key Phase III studies for anti-epilepsy treatment Zonegran^® (zonisamide/ZNS). The zonisamide in monotherapy study and the CATZ study, zonisamide in paediatric patients, will be presented for the first time during the 29^th International Epilepsy Congress (IEC), taking place in Rome, Italy from 28 August until 1 September, 2011. In addition, posters highlighting results from the new phase IV studies ZADE, OZONE and ZENIT, on the impact of zonisamide on everyday clinical practice in Europe, will also be presented.

The double-blind, randomised, multicentre monotherapy study set out to compare the efficacy and safety of once-daily zonisamide with twice-daily controlled release carbamazepine as monotherapy in 583 adults with newly diagnosed partial epilepsy. The double-blind, randomised, multicentre, placebo-controlled CATZ study set out to assess the efficacy and safety/tolerability of adjunctive zonisamide in 207 paediatric patients (6-17 years) with partial-onset seizures who were on one or two anti-epileptic drugs. The ZADE study evaluated efficacy, tolerability and quality of life (QOL) effects of adjunctive zonisamide in patients with partial seizures treated in everyday clinical practice in Germany and Austria. The OZONE study evaluated the efficacy and tolerability of zonisamide in current medical practice in patients aged ≥ 18 years with focal epilepsy treated by neurologists in hospital or private offices in France. The ZENIT study evaluated a range of outcomes in epilepsy patients being prescribed zonisamide in everyday clinical practice in Denmark, Finland, Norway and Sweden.

"These study results highlight our commitment to developing and delivering epilepsy treatments that really help improve the lives of people with epilepsy," said Dr Bettina Bauer, Head of EU Epilepsy Business Unit, Eisai Europe. "Zonisamide is just one example of Eisai's strong epilepsy product portfolio".

The European Medicines Agency has accepted for review Eisai's license extension application for zonisamide as a monotherapy for newly diagnosed epilepsy patients with partial seizures, with or without secondary generalisation.

The following Eisai zonisamide abstracts are accepted for presentation at this year's International Epilepsy Congress meeting:

    Reference              Abstract name/author
    Platform Session 4:    Comparison of zonisamide and carbamazepine
    Pharmacotherapy        monotherapy in adults with newly diagnosed
    Reference: p869        partial epilepsy: preliminary results of a
    Date: 30 August 2011   phase III, randomised, double-blind,
    Time: 14.00-15.45      non-inferiority trial
                           M. Baulac

    Poster session: Late   Preliminary results from the CATZ Study: a
    submissions            phase III, double-blind, randomised,
    Reference: p870        placebo-controlled trial to assess the
    Date: 31 August 2011   efficacy and safety of adjunctive zonisamide
                           in paediatric patients with partial-onset
                           seizures
                           R. Guerrini
                           Poster presentation

    Poster session:        Adjunctive zonisamide in clinical practice:
    adult epileptology X   results from the non-interventional ZADE
    Reference: p508        study
    Date: 30 August 2011   H. Stefan
                           Poster Presentation

    Poster session: adult  OZONE: a prospective, observational,
    epileptology X         open-label study of patients with partial
    Reference: p509        epilepsy treated with adjunctive zonisamide
    Date: 30 August 2011   therapy in everyday clinical practice in
                           France
                           S. Dupont
                           Poster Presentation

    Poster session: adult  A 12-month observational nordic study in
    epileptology X         epilepsy patients prescribed zonisamide in
    Reference: p510        everyday clinical practice: preliminary
    Date: 30 August 2011   results from ZENIT
                           K. Nakken
                           Poster Presentation

Notes to Editors

Media briefing

A media briefing will be held at the International Epilepsy Congress at 16.00 - 17:30 on 29 August 2011. Please contact Benjamyn Tan if you would like to attend or require more information (benjamyn.tan@toniclc.com).

About Zonegran^® (zonisamide)

Zonisamide is licensed as adjunctive therapy in the treatment of partial seizures (with or without generalisation) in adults with epilepsy.  It has a broad-spectrum of anti-epileptic modes of action and has no appreciable effects on steady-state plasma concentrations of other anti-epileptic drugs, such as phenytoin, carbamazepine, and valproate.^[1]

Zonisamide is available in 25mg, 50mg, and 100mg capsule strengths. The recommended initial daily dose is 50mg in two divided doses. After one week the dose may be increased to 100mg daily and thereafter the dose may be increased at weekly intervals, in increments of up to 100mg.

Eisai 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 anti-epileptic drugs (AEDs) is a major strategic area for Eisai.

Eisai currently has three marketed treatments in Europe including:

• Zonegran^® (zonisamide) as adjunctive therapy in adult patients with partial-onset seizures, with or without secondary generalisation. (Zonegran is under license from the originator, Dainippon Sumitomo Pharma)
• Zebinix^® (eslicarbazepine acetate) as adjunctive therapy in adult patients with partial-onset seizures, with or without secondary generalisation. (Zebinix is under license from BIAL)
• Inovelon^® (rufinamide) for adjunctive treatment, 4 years and older of seizures associated with Lennox-Gastaut Syndrome.

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 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, severe sepsis, rheumatoid arthritis, psoriasis, Crohn's disease

With operations in the U.S., Asia, Europe and its domestic home market of Japan, we employ 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, Hungary, Slovakia and the Netherlands.

For further information please visit our web site http://www.eisai.com

1. Eisai Ltd. Zonegran Summary of Product Characteristics (Last updated July 2011)