Eisai will present new trials conducted with Zonegran (R) in the International Congress on epilepsy.

Monotherapy, randomized, double blind and multicenter study was conducted to compare the efficacy and safety of Zonisamide monotherapy administered 1 time/day vs carbamazepine delayed release administered 2 times / day in 583 adults with newly-diagnosed partial epilepsy. The CATZ study, double-blind, randomized, multicenter placebo-controlled, was conducted to assess the efficacy and safety/tolerability of adjuvant Zonisamide in 207 pediatric patients (between 6 and 17 years), and with partial onset seizures taking one or two antiepileptic drugs. The ZADE study evaluated the efficacy, tolerability and the effects on the quality of life (QOL) of Zonisamide (ZNS) as adjunctive therapy in patients with partial seizures treated in daily clinical practice in Germany and Austria. The study OZONE assessed the efficacy and tolerability of Zonisamide in current medical practice in patients over the age of 18 years with focal epilepsy treaties by neurologists in hospitals or private clinics in France. The ZENIT study evaluated a range of variables in patients with epilepsy who was administered Zonisamide in daily clinical practice in Denmark, Finland, Norway and Sweden.

“The results of these studies demonstrate our commitment to the development and commercialization of treatments for epilepsy that can really help improve the lives of people with epilepsy”, says Dr. Bettina Bauer, head of business unit of epilepsy for the EU, Eisai Europe, “Zonisamide is an example of the strong portpofio of drugs for epilepsy that offers Eisai”.

The European Medicines Agency has agreed to review the request for extension of the license from Eisai Zonisamide as monotherapy for newly diagnosed patients with partial seizures epilepsy, with or without secondary generalization.

The following summaries on Zonisamide for presentation at the International Congress on epilepsy of this year have been accepted:

reference name/author of the abstract Platform Session 4: comparison of Pharmacotherapy and Zonisamide monotherapy carbamazepine in adult patients with reference: p869 recently diagnosed partial Epilepsy: date: 30 preliminary results August of a 2011 phase trial III, randomized, double blind and absence time: 14.00-15.45 inferiority. CATZ study preliminary results meeting Baulac M.: a presentation: phase III, randomized and controlled reference: p870 placebo, double-blind to assess date: 31 of efficacy and safety of Zonisamide as August 2011 adjunctive therapy in pediatric patients with partial onset seizures. R. Guerrini presentation poster session adjuvant Zonisamide in clinical practice: presentation: results of the non-interventionist study epilepsy for ZADE. Adult X H. Stefan reference: p508 Presentación poster date: 30 August 2011 session of OZONE: a prospective, observational study and presentation: open from patients with partial epilepsy that epilepsy for received treatment with Zonisamide adults X coadjuvant in daily clinical practice in reference: p509 France. Join date: S. Dupont 30 Aug 2011 Presentación poster session of an observational study of 12 months made presentation: in the Nordic countries in patients of epilepsy for epilepsy that is them prescribed Zonisamide adults X in daily clinical practice: results reference: preliminary p510 of ZENIT. Join date: k. Nakken 30 Aug 2011 Presentación poster

About r Zonegran (Zonisamide)

Zonisamide is approved as adjunctive therapy for the treatment of partial seizures (with or without secondary generalization) in adults with epilepsy. It has broad spectrum anticonvulsant action mechanisms and does not have significant effects on concentrations of plasma in steady state of other antiepileptic drugs, such as phenytoin, carbamazepine and valproate.[1]

Zonegran r is available in capsules of 25 mg, 50 mg and 100 mg. the recommended initial daily dose is 50 mg in two doses separated. After a week the dose can be increased to 100 mg daily and subsequently the dose can be increased at weekly intervals in increments of up 100 mg.

In Europe, Eisai currently sells three drugs:

-r Zonegran (Zonisamide) as adjuvant therapy in adult patients with partial onset seizures, with or without secondary generalization. (Zonegran is marketed under license from its original creator, Dainippon Sumitomo Pharma).

-Zebinix (R) (eslicarbazepina acetate) as adjuvant therapy in adult patients with crisis of partial onset, with or without secondary generalization (Zebinix marketed under license from BIAL).

-R Inovelon (rufinamide) for adjuvant treatment in patients 4 years and older of crisis associated with Lennox-Gastaut syndrome.

Close deEisai

Eisai focuses its r & d activities in three key areas:

-area of Neuroscience: Alzheimer’s, multiple sclerosis, pain, epilepsy, depression, neuropathic, etc.

-Area of Oncology: cancer treatments; tumour-regressing, tumor suppression, antibodies, etc., and complementary treatments for cancer; relief of pain, nausea, etc.

-Vascular and immune reaction which includes acute coronary syndrome, disease concurrence, sepsis, rheumatoid arthritis, psoriasis, disease Crohn, etc.

Eisai, which develops its activity in the United States.USA, Asia, Europe and in their national market of Japan, has over 11,000 employees working throughout the world. In Europe, Eisai has subsidiaries in more than 20 countries including United Kingdom, France, Germany, Italy, Spain, Switzerland, Sweden, Ireland, Austria, Denmark, Finland, Norway, Portugal, Iceland, Czech Republic, Hungary, Slovakia and the Netherlands.

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Referencia:

1. Eisai Ltd. (2005). Zonegran Summary of Product Characteristics (technical specifications)