French Transparency Commission Recognises Efficacy of Zonegran® (zonisamide) Monotherapy

Hatfield, England (ots/PRNewswire) - Transparency advice for Zonegran(R) (zonisamide) monotherapy in the
treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy, has been published by the French National Authority for Health (HAS).[1] The Transparency Commission advice awards zonisamide a Medical Benefit (SMR) level of 'important' and an Improvement of Medical Benefit (ASMR) level 'V'. The advice recognises zonisamide's level A efficacy rating.[2]

Once-daily zonisamide is a second generation anti-epileptic drug (AED) with multiple mechanisms of action and a chemical structure unrelated to any other AEDs.[3] Zonisamide is already available in France as adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults over the age of 18.[3]

Monotherapy is the optimal treatment approach for newly diagnosed epilepsy, as most people with the condition may be successfully managed with the first or second monotherapy. In comparison with polytherapy, monotherapy also reduces the potential for adverse drug interactions.[4]

"Zonisamide's proven efficacy in the monotherapy setting makes it a welcome addition to doctors' epilepsy treatment armamentarium in France," commented Professor Michel Baulac, Head of the Epilepsy department at the Pitie-Salpetrière Hospital, Paris, France.

Epilepsy is one of the most common neurological conditions in the world.[5] Around 450,000 people in France live with the condition, with over 100 new cases diagnosed each day.[6]

"As a leader in epilepsy in Europe, Eisai is committed to not only bring innovative new therapies to market, but also ensure that we maximise the clinical benefits of our currently licensed products. We are pleased to introduce Zonegran as monotherapy for adults with newly diagnosed epilepsy in France, in addition to as adjunctive therapy for adults," commented Lysiane Bernal-Gallois, Chief Pharmacist, Eisai France.

The efficacy and safety of zonisamide as monotherapy has been demonstrated in a double-blind, randomised, multicentre study of 583 newly diagnosed adult partial epilepsy patients, which compared the efficacy and safety of once-daily zonisamide with twice-daily controlled release carbamazepine as monotherapy. The study's primary endpoint was the proportion of seizure-free patients for 26 weeks or more. Zonisamide demonstrated high seizure freedom rates in newly diagnosed patients with epilepsy,[7] similar to controlled release carbamazepine. In the majority of patients, seizure freedom was achieved at the target dose of 300 mg. Zonisamide was considered non-inferior to carbamazepine and was well tolerated after one year of treatment at doses ranging from 300 to 500 mg/day.

The use of adjunctive zonisamide in the treatment of partial seizures (with or without secondary generalisation) in children aged six years and above was approved by the European Commission in October 2013. Eisai has submitted a file to HAS in France for this new indication, with advice expected later this year.

The continued development of zonisamide underscores Eisai's human health care (hhc) mission, the company's commitment to innovative solutions in 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 with epilepsy and their families. Eisai is proud to currently market more epilepsy products in EMEA than any other company.

***ENDS***

Notes to Editors

About Zonegran (zonisamide)

Zonisamide is licensed in Europe as monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy. Zonisamide is also indicated in Europe as adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults, adolescents and children aged six years and above.[3] 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.[3] Zonisamide is one of only four AEDs with level A efficacy/effectiveness evidence as initial monotherapy for adults with partial onset seizures.[2]Worldwide there has been an estimated 1,274,963 patient-years of exposure to zonisamide (from 31.03.1989 to 31.03.2013).[8]

Zonisamide is available in 25mg, 50mg, and 100mg capsule strengths. The recommended daily dose for monotherapy use is 100mg once daily. In the third and fourth weeks the dose may be increased to 200mg daily and then increased to 300mg daily after the next two weeks.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.[3]

For further information please visit: http://www.zonegran.eu

About Epilepsy

Epilepsy is one of the most common neurological conditions in the world, affecting approximately eight in 1,000 people in Europe, and an estimated 50 million people worldwide.[9],[10] 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 EMEA in Epilepsy

Eisai is committed to the development and delivery of 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 Europe, the Middle East, Africa, Russia and Oceania (EMEA).

In the EMEA region, Eisai currently has four marketed treatments including:

  • Fycompa(R) (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
  • Inovelon(R) (rufinamide) for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in patients >4 years. (Rufinamide was originally developed by Novartis)
  • Zonegran(R) (zonisamide) as monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy and as adjunctive therapy in the treatment of partial seizures, with or without generalisation, in adults, adolescents and children aged six years and above. (Zonegran is under license from the originator Dainippon Sumitomo Pharma).
  • Zebinix(R) (eslicarbazepine acetate) as adjunctive therapy in adult patients with partial onset seizures, with or without secondary generalisation. (Zebinix is under license from BIAL).

About Eisai Co., Ltd.

Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. With over 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realise our hhc philosophy by delivering innovative products in various therapeutic areas with high unmet medical needs, including Oncology and Neurology.

As a global pharmaceutical company, our mission extends to patients around the world through our investment and participation in partnership-based initiatives to improve access to medicines in developing and emerging countries.

For more information about Eisai Co., Ltd., please visit http://www.eisai.com.

References

1. http://www.has-sante.fr/portail/jcms/c_1761866/fr/zonegran?xtmc=&x tcr=2

2. Glauser T. et al. Updated ILAE evidence review of antiepileptic drug efficacy and effectiveness as initial monotherapy for epileptic seizures and syndromes. Epilepsia. 2013;54(3):551-63

3. Zonegran, Summary of Product Characteristics (updated October 2013): http://www.medicines.org.uk/emc/medicine/16240 (accessed September 2014)

4. St. Louis, K. et al. Antiepileptic Drug Monotherapy: The Initial Approach in Epilepsy Management. 2009: 2:77-72

5. ILAE/IBE/WHO, Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe 2010. Available at; http://www.ilae.org/Visit ors/Documents/ILAEAnnual-Report2010Final_000.pdf (accessed September 2014)

6. http://sante-medecine.commentcamarche.net/contents/731-epilepsie-s tatistiques-en-france (accessed September 2014)

7. Baulac, M. Efficacy and tolerability of zonisamide versus controlled-release carbamazepine for newly diagnosed partial epilepsy: a phase 3, randomised, double-blind, non-inferiority trial. Lancet Neurology. 2012:11(7):579-588

8. Data on file: ZON2013-0003. Eisai Europe Ltd.

9. Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe.
http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf
(accessed September 2014)

10. Pugliatti M et al. Estimating the cost of epilepsy in Europe: A review with economic modeling. Epilepsia 2007:48(12):2224-2233

Date of preparation: October 2014

Job code: Zonegran-UK2527

Digital press kit: http://www.ots.at/pressemappe/PR64962/aom

Rückfragen & Kontakt:

Media Enquiries: Eisai Europe Ltd, Cressida Robson/Ben Speller,
+44(0)7908-314-155/+44(0)7908 409416, Cressida_Robson@eisai.net,
Ben_Speller@eisai.net; Tonic Life Communications, Frances
Murphy/Nicola
Lilley, +44(0)207-798-9262 /+44(0)207-798-9905,
frances.murphy@toniclc.com,
nicola.lilley@toniclc.com

ORIGINAL APA-OTS TEXT - THE INFORMATION CONTAINED IN THIS PRESS RELEASE IS SUBJECT TO THE EXCLUSIVE RESPONSIBILITY OF THE ISSUER | PRN0001