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
=&xtcr=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-epilepsi
e-statistiques-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

ots Originaltext: Eisai Europe Limited
Im Internet recherchierbar: http://www.presseportal.de

Contact:
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+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