New Research on Eisai

New Research on Eisai's Antiepileptic Drug Zonegran®(Zonisamide) Presented at European Congress on Epileptology (ECE)

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New Research on Eisai's Antiepileptic Drug Zonegran®(Zonisamide) Presented at European Congress on Epileptology (ECE) PR Newswire ®New data on the novel anti-epileptic drug (AED) Zonegran (zonisamide) is presented today at the 10th European Congress on Epileptology (ECE) in London. Since July 2012, zonisamide has been licensed in the EU as a monotherapy for newly diagnosed-adults who have partial seizures, with and [1]without secondary generalisations, and also as an adjunctive therapy. Certain patient population may require additional studies to demonstrate efficacy and safety compared to the general adult population. In elderly patients, caution maybe required when making dose recommendations. Data from elderly patients from the pivotal phase III studies were examined to see if differences could be determined in respect to the use of zonisamide. Findings from the studies showed that the safety and efficacy of zonisamide were similar to those reported in the general adult population. In addition, paediatric patients sometimes require specific dosing regimens, and additional safety and tolerability evidence beyond that available for adult populations. Zonisamide, which does not have paediatric licence, is currently under investigation in a paediatric patient population (6-17 years) for adjunctive use in partial-onset seizures in Europe.

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New Research on Eisai's Antiepileptic Drug Zonegran®(Zonisamide) Presented at European Congress on Epileptology (ECE) PR Newswire
® New data on the novel anti-epileptic drug (AED) Zonegran(zonisamide) is presented today at the 10th European Congress on Epileptology (ECE) in London. SinceJuly 2012, zonisamide has been licensed in the EU as a monotherapy for newly diagnosed-adults who have partial seizures, with and [1] without secondary generalisations, and also as an adjunctive therapy. Certain patient population may require additional studies to demonstrate efficacy and safety compared to the general adult population. In elderly patients, caution maybe required when making dose recommendations. Data from elderly patients from the pivotal phase III studies were examined to see if differences could be determined in respect to the use of zonisamide. Findings from the studies showed that the safety and efficacy of zonisamide were similar to those reported in the general adult population. In addition, paediatric patients sometimes require specific dosing regimens, and additional safety and tolerability evidence beyond that available for adult populations. Zonisamide, which does not have paediatric licence, is currently under investigation in a paediatric patient population (6-17 years) for adjunctive use in partial-onset seizures inEurope. The following Eisai posters are being presented at this year's ECE:
 PosterSession  Medicaltherapy andZonisamide  pharmacology2 Abstractp177  MondayOctober 1Giorgi L, Chouette I  12:39-12:48
 PosterSession  Medicaltherapy and  pharmacology3 Zonisamide  MondayOctober 1Abstract p178  14:00Giorgi L, Chouette I
 PosterSession  Medicaltherapy and  pharmacology2 Zonisamide  MondayOctober 1Abstract p166  12:30-12:39Rosati A, Segieth L, Giorgi L, Guerrini R  PosterSession  Antiepilepticdrugs Zonisamide  MondayOctober 1Abstract p019  11:30Hall GTrinka E, Segieth L, Giorgi L  PosterSession  Medicaltherapy and  pharmacology10 Zonisamide  WednesdayOctober 3Abstract p663  12:57-13:06Baulac M, Rugg-Gunn F, Chouette I
The development of zonisamide underscores Eisai'shuman health caremission, 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 with epilepsy and their families. Eisai is proud to currently market more epilepsy products in EMEA than any other company.
About Zonegran (zonisamide)
Zonisamide is licensed inEuropeas monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy. In addition, zonisamide is also indicated 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 [1] AEDs, such as phenytoin, carbamazepine and valproate. Zonisamide is 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 [1] dose may be increased at weekly intervals, in increments of up to 100 mg. For more information please visit:http://www.zonegran.eu
About Epilepsy
Epilepsy is one of the most common neurological conditions in the world, [2] affecting approximately eight in 1,000 people inEuropeare an. There estimated six million people living with epilepsy inEurope, and an estimated 50 [3] million people with the condition worldwide.Epilepsy is a chronic disorder of the brain that affects people of all ages. It is characterised by abnormal discharges of neuronal activity causing seizures. Seizures can vary in severity, from brief lapses of attention or jerking of muscles, to severe and prolonged convulsions. Depending on the seizure type, seizures may be limited to one part of the body, or may involve the whole body. Seizures can also vary in frequency from less than one per year, to several per day. Epilepsy has many possible causes but often the cause is unknown.
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 inEurope, theMiddle East,Africaand Russia(EMEA). In the EMEA region, Eisai currently has four marketed treatments including:
® Zonegran (zonisamide)as monotherapy and 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 (eslicarbazepineacetate) as adjunctive therapy in adult patients with partial-onset seizures, with or without secondary generalisation. (Zebinix is under license from BIAL) ® Inovelon (rufinamide)for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in patients >4 years ® Fycompa (perampanel)for use as an adjunctive treatment for partial onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older
About Eisai:
Eisai recently expanded their UK Hatfield commercial, research and manufacturing facility which now supports the company's growing EMEA business. Eisai concentrates its R&D activities in three key areas:
Neuroscience, including: Alzheimer's disease, epilepsy, pain and weight loss ® Fycompa (perampanel)for use as an adjunctive treatment for partial onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older Oncology including: anticancer therapies; tumour regression, tumour suppression, antibodies, etc. Vascular/Immunological reaction including: thrombocytopenia, rheumatoid arthritis, psoriasis, inflammatory bowel disease
With operations in the U.S.,Asia,Europeand its domestic home market of Japan, Eisai employs more than 11,000 people worldwide. InEurope, 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, the Netherlands,Belgium,Luxembourg, theMiddle EastandRussia. For further information please visit our web sitehttp://www.eisai.com. References 1. ZonegranSPChttp://www.medicines.org.uk/emc/medicine/16240/SPC/ 2. Pugliatti M et al. Estimating the cost of epilepsy in Europe: A review with economic modeling. Epilepsia 2007: 48(12) 2224 - 2233. 3. Epilepsy in the WHO European Region: Fostering Epilepsy Care inEurope.http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf[Accessed10 April 2012]. Date of preparation:September 2012
Job code: Zonegran-UK2456