Zonegran® (zonisamide) Reimbursed in Switzerland as Monotherapy Treatment for Adults With Newly Diagnosed Partial Epilepsy

Zonegran® (zonisamide) Reimbursed in Switzerland as Monotherapy Treatment for
                 Adults With Newly Diagnosed Partial Epilepsy

  PR Newswire

  HATFIELD, England, January 23, 2014

HATFIELD, England, January 23, 2014 /PRNewswire/ --

PRESS RELEASE FOR EUROPEAN MEDIA ONLY NOT FOR U.S. MEDIA

Zonegran also receives Swissmedic approval as adjunctive therapy for children
                               and adolescents

Zonegran ^® (zonisamide) has received reimbursement in Switzerland by the
Federal Office of Public Health (FOPH) as monotherapy in the treatment of
partial seizures, with or without secondary generalisation, in adults with
newly diagnosed epilepsy. The reimbursement for zonisamide follows Swissmedic
approval earlier this year. Zonisamide is also now available for the treatment
of partial epilepsy in children and adolescents in Switzerland following the
paediatric license extension approval by the European Commission in October
2013.

Already available in Switzerland as adjunctive therapy for the treatment of
partial seizures with or without secondary generalisation in patients over the
age of 18, 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. ^[1] Monotherapy is the favoured approach in managing newly
diagnosed epilepsy as most people with epilepsy may be successfully managed
with the first or second monotherapy. In comparison with polytherapy,
monotherapy also reduces the potential for adverse drug interactions. ^[2]

"Effective seizure management still remains a challenge for up to a third of
people with partial onset seizure despite appropriate therapy. The
reimbursement of Zonegran as monotherapy in adults and the approval as
adjunctive therapy in children and adolescents offers another treatment option
that can potentially help people in Switzerland achieve better seizure
control," commented Dr. Günter Krämer,Neurologist, Neurozentrum Bellevue,
Zurich.

Epilepsy is one of the most common neurological conditions in the world ^[3]
and an estimated 70,000 people live with epilepsy in Switzerland. ^[4] The
incidence of uncontrolled partial epilepsy remains high despite many new AEDs,
and between 20-40% of people with newly diagnosed epilepsy will become
refractory to treatment. ^[5]

The efficacy and safety of zonisamide as monotherapy was 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 at six months. Zonisamidedemonstrated high response rates for
achieving seizure freedom in newly diagnosed patients with epilepsy, ^[6]
similar to controlled release carbamazepine. In the majority of patients,
seizure freedom was achieved at the target dose of 300 mg with once daily
dosing. Zonisamide was considered non-inferior to carbamazepine, was well
tolerated, and had no apparent safety concerns after one year of treatment at
doses ranging from 300 to 500 mg/day.

"We are pleased to receive the new extended monotherapy and adjunctive therapy
indication for Zonegran in Switzerland which reinforces Eisai's human health
care mission ( hhc ) to provide effective treatments to patients worldwide,"
said Christiane Kordeuter, Epilepsy Business Unit Director, Eisai Switzerland.

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

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 as adjunctive therapy in the
treatment of partial seizures, with or without secondary generalisation, in
adults, adolescents and children aged six years and above. ^[1] 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. ^[1] Zonegran is one of only four
AEDs with level A efficacy/effectiveness evidence as initial monotherapy for
adults with partial onset seizures. ^[7]

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 100mg. ^[1]

For more 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. ^[8] ^, ^[9] Epilepsy is a chronic disorder of the
brain that affects people of all ages. It is characterised by abnormal
discharges of neuronal activity which causes 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 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 Europe, the Middle East,
Africa, Russia and Oceania (EMEA).

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

  *Zonegran ^® (zonisamide) as monotherapy in adults and adjunctive therapy
    in adults, adolescents and children aged six years and above with partial
    onset seizures, with or without secondary generalisation. (Zonegran is
    under license from the originator Dainippon Sumitomo Pharma)
  *Zebinix ^® (eslicarbazepine acetate) 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.
    (Rufinamide was originally developed by Novartis)
  *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 is one of the world's leading research and development (R&D) based
pharmaceutical companies and 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 human health care ( hhc ).

Eisai concentrates its R&D activities in three key areas:

  *Neuroscience, including: Alzheimer's disease, epilepsy, pain and weight
    loss
  *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, Europe and its domestic home market of
Japan, Eisai employs more than 10,000 people worldwide. From its EMEA
Knowledge Centre in Hatfield, UK, Eisai has recently expanded its business
operations to include Europe, the Middle East, Africa, Russia and Oceania
(EMEA). Eisai EMEA has sales and marketing operations in over 20 markets,
including the United Kingdom, France, Germany, Italy, Spain, Switzerland,
Sweden, Ireland, Austria, Denmark, Finland, Norway, Portugal, Czech Republic,
Slovakia, the Netherlands, Belgium, Russia and the Middle East.

For further information please visit our web site http://www.eisai.co.uk

References

1.Eisai Ltd 2013. Zonegran summary of product characteristics (last updated
    October 2013)
    https://www.medicines.org.uk/emc/history/16240/SPC/Zonegran+25,+50,+100+mg+Hard+Capsules
2.St. Louis, K. Rosenfeld. W. Bramley, T. Antiepileptic Drug Monotherapy:
    The Initial Approach in Epilepsy Management (2009) &(2): 77-72
3.ILAE/IBE/WHO, Epilepsy in the WHO European Region: Fostering Epilepsy Care
    in Europe 2010. Available at;
    http://www.ilae.org/Visitors/Documents/ILAEAnnual-Report2010Final_000.pdf
    (Accessed Feb 2013)
4.EPI Swiss Epilepsy Centre. Available at:
    http://www.epi.ch/page.php?pages_id=301&language=fr (Accessed November
    2013)
5.French JA. Refractory Epilepsy; Clinical Overview. Epilepsia 2007: 48
    (Suppl1) 3 - 7.
6.Baulac M. et al. 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
7.Glauser T. et al. Updated ILAE evidence review of antiepileptic drug
    efficacy and effectiveness as initial monotherapy for epileptic seizures
    and syndromes.
8.Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe.
    http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf
    (Accessed December 2013)
9.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: November 2013 Job code: Zonegran-UK2515

Contact: Media Enquiries: Eisai Europe Ltd, Cressida Robson/Charlotte Andrews,
+44(0)7908 314 155/+44(0)7947 231 513, Cressida_Robson@eisai.net,
Charlotte_Andrews@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
 
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