Lancet Neurology Publishes Pivotal Phase III Data Supporting Zonegran® (Zonisamide) as a Once-Daily Monotherapy for Newly Diagnosed Partial Onset Epilepsy Patients

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• Langue: English

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Lancet Neurology Publishes Pivotal Phase III Data Supporting Zonegran® (Zonisamide) as a Once-Daily Monotherapy for Newly Diagnosed Partial Onset Epilepsy Patients

PR Newswire HATFIELD, England, June 27, 2012

HATFIELD,England,June 27, 2012/PRNewswire/ -- New monotherapy options are needed as up to a third of epilepsy [1] patients remain uncontrolled Leading international journal, The Lancet Neurology, today published positive ® results from a new pivotal Phase III Zonegran(zonisamide) monotherapy study showing that once-daily zonisamide is non-inferior to controlled-release ® carbamazepine (Tegretolretard) and could prove to be a useful initial [2] monotherapy for newly diagnosed partial onset epilepsy patients Carbamazepine is the most well-established monotherapy comparator for patients newly diagnosed with partial onset seizures (the most common type of [2] epilepsy). Commenting on the results, Professor Michel Baulac, manuscript lead author and head of the clinical department at the Hospital de la Pitie-Salpetriere,Paris, Francesaid; "These data will be of key interest to general neurologists and epileptologists acrossEuropeas they demonstrate that zonisamide is effective and non-inferior to the standard first line monotherapy. It is essential to ensure newly diagnosed epilepsy patients achieve adequate seizure control, so a potential new and effective monotherapy treatment option is very exciting." The double-blind, randomised, multicentre study of 583 adult patients with [2] newly diagnosed partial epilepsy (282 zonisamide, 301 carbamazepine), set out to compare the efficacy and safety of once-daily zonisamide with twice- daily controlled release carbamazepine as a monotherapy for these patients. 456 patients were analysed for the primary end point (per protocol population) and the results show that 79.4% (177 of 223) patients in the zonisamide group and 83.7% (195 of 233) patients in the carbamazepine group were seizure-free for 26 weeks or more (adjusted absolute treatment difference -4.5%, 95% CI - [2] 12.2 to 3.1).The statistical comparison between zonisamide and carbamazepine met the criterion of non-inferiority (relative difference) as recommended by treatment guidelines set out by the International League Against Epilepsy (ILAE). The incidence of treatment-emergent adverse events in the study was [2] comparable between the zonisamide and carbamazepine groups.The most frequently reported treatment-emergent adverse events (≥5% patients in either group) were headache, decreased appetite, somnolence, dizziness and [2] [2] weight loss.There were no new or unexpected safety findings in the trial. Zonisamide is currently indicated as adjunctive therapy in the treatment of adult patients with partial seizures, with or without secondary generalisation.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recently issued a positive opinion for extending the use of once-daily zonisamide as monotherapy for the treatment of partial seizures (with or without secondary generalisation) in adults with newly diagnosed epilepsy. EU approval of the monotherapy indication is anticipated within three months. Dr Bettina Bauer, Head of EMEA Epilepsy Business Unit, Eisai Europe said; "There is a need for new monotherapy options to allow physicians the ability to offer newly diagnosed epilepsy patients with a wider choice of first-line treatment. These study results, coupled with the CHMP's recent positive recommendation for monotherapy licence, suggest the important new role that this established therapy may soon play in improving seizure control in newly diagnosed epilepsy patients acrossEurope." Zonisamide is a second generation anti-epileptic drug (AED) with multiple mechanisms of action and a chemical structure unrelated to other AEDs which [3] means it is unlikely to interact with other drugs.Importantly, it has pharmacokinetic properties allowing for the clinical advantage of once-daily dosing. For patients with newly diagnosed partial onset epilepsy, monotherapy is the preferred option for managing their condition as this reduces the [4] potential for adverse drug interactions. The continued investment in zonisamide underscores Eisai'shuman health care mission, the company's commitment to innovative solutions in disease prevention, cure and care for the health and wellbeing of people worldwide. Eisai is committed to the therapeutic area of epilepsy and addressing the unmet medical needs of patients and their families.

About Zonegran (zonisamide)

Zonisamide is licensed inEuropeas 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 AEDs, such as [3] 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 [3] dose may be increased at weekly intervals, in increments of up to 100 mg.

About Epilepsy

Epilepsy is one of the most common neurological conditions in the world, [5] affecting approximately eight in 1,000 people inEuropeare an. There [6] estimated six million people living with epilepsy inEuropeand an estimated 50 [7] million people with the condition worldwideEpilepsy 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 in the European market. InEurope, Eisai currently has three marketed treatments 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 (eslicarbazepineacetate) as adjunctive therapy in adult patients with partial- onset seizures, with or without secondary generalisation ® Inovelon (rufinamide)for the adjunctive treatment of seizures associated with Lennox- Gastaut Syndrome in patients >4 years

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,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, Slovenia,the Netherlands, andBelgium. For further information please visit our web site http://www.eisai.com References 1. Schmidt,D. Drug treatment of epilepsy: Options and limitations. Epilepsy & Behaviour. 2009: 15, 55-65

versus controlled-release carbamazepine for newly diagnosed partial epilepsy: a phase 3, randomised, double-blind, non-inferiority trial. Lancet Neurology. Published online: http://www.thelancet.com/journals/laneur/article/PIIS1474- 4422(12)70105-9/abstract (June 2012) 3. Eisai Ltd. (2005). Zonegran Summary of Product Characteristics [ http://emc.medicines.org.uk ] 4. St.Louis, K. Rosenfeld. W. Bramley, T. Antiepileptic Drug Monotherapy: The Initial Approach in Epilepsy Management (2009) &(2): 77 - 72 5. Pugliatti M et al. Estimating the cost of epilepsy in Europe: A review with economic modeling. Epilepsia 2007: 48(12) 2224 - 2233. 6. ILAE/IBE/WHO, Epilepsy in the WHO European Region: Fostering Epilepsy Care inEurope2010. Available from; http://www.ilae- (Accessed epilepsy.org/Visitors/Documents/EUROReport160510.pdf June 2011) 7. Epilepsy Society UK: http://www.epilepsysociety.org.uk/AboutEpilepsy/Whatisepilepsy/Epilepsy- (AccessedJune 2011) didyouknow