Eisai Announces New Partnership with Esteve to Promote Anti-epilepsy Drug Zonegran® (Zonisamide) in Spain

  Eisai Announces New Partnership with Esteve to Promote Anti-epilepsy Drug
                       Zonegran® (Zonisamide) in Spain

  PR Newswire

  HATFIELD, England, December 10, 2013

HATFIELD, England, December 10, 2013 /PRNewswire/ --

Eisai announces today that it has selected Esteve, a Spanish pharmaceutical
company with a comprehensive neurology franchise, to become its epilepsy
partner in Spain to promote Zonegran ^® (zonisamide). Zonisamide, a novel
anti-epileptic drug (AED) with multiple mechanisms of action and a chemical
structure unrelated to any other AED, is indicated 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 secondary generalisation, in
adults, adolescents and children aged six years and above. ^[1]

"As a research-based pharmaceutical company with a particular focus on
epilepsy, we are not only committed to bringing innovative new therapies to
market, but also ensuring that we maximise access to our currently licensed
products," comments Gary Hendler, President and CEO, Eisai EMEA. "Our
partnership with one of Spain's leading pharmaceutical companies, Esteve for
Zonegran in Spain will allow Eisai to focus our efforts and resources on a
broad epilepsy portfolio, and we believe strongly that our new promotion
strategy will allow us to become the leading company in epilepsy by 2015."

"The alliance in epilepsy between Esteve and Eisai is a new milestone for our
company and will allow us to foster and consolidate our presence in one of our
core business areas: central nervous system" explains Albert Esteve, CEO of
Esteve.

Epilepsy is a common neurological condition that causes recurrent seizures in
the brain. ^[2] It is usually diagnosed in children and people over 65 years
of age, although it can affect anyone. ^[2] Currently, up to 22,000 people are
diagnosed with epilepsy each year in Spain, of whom around one third have
seizures that are not completely controlled by their anti-epileptic therapy.
^[3]

The new partnership with Esteve in Spain is yet another example of Eisai's
human health care mission. Eisai is committed to the therapeutic area of
epilepsy and addressing the unmet medical needs of people with epilepsy. Eisai
is proud to currently market more epilepsy products in EMEA than any other
company, and is dedicated to becoming the number one epilepsy company in
Europe (by sales) by 2015, as stated in its Hayabusa plan.

                                 *** 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 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. ^[4]

Zonisamide is available in 25mg, 50mg, and 100mg capsule strengths. The
recommended initial 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. ^[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. ^[5] ^,[6] 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 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:

  *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
  *Zonegran ^® (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 ^® (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)

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

About Esteve

Esteve is a leading pharmaceutical chemical group based on Barcelona,
Spain.Since it was founded in 1929, Esteve has been firmly committed to
excellence in healthcare, dedicating efforts to innovative R&D of new
medicines for unmet medical needs and focusing on high science and
evidence-based research. Esteve has a strong partnership approach to drug
discovery, development and commercialisation. The company works both
independently and in collaboration to bring new, differentiated best-in-class
treatments to patients who need them. The company currently has a team of
about 2300 professionals, and has subsidiaries and production facilities in
several European countries, USA, China and Mexico.

For further information, please visit http://www.esteve.com

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. Epilepsy Research UK. What is Epilepsy? Factsheet. Available from URL:
http://epilepsyresearch.org.uk/wp-content/uploads/2012/03/1_what_is_epilepsy.pdf
(Last accessed May 2013)

3. García-Ramos R, et al. Neurología. 2011; 26:548-55.
http://www.elsevier.es/sites/default/files/elsevier/eop/S2173-5808(11)00042-3.pdf
(Last accessed May 2013)

4. Glauser T. et al. Updated ILAE evidence review of antiepileptic drug
efficacy and effectiveness as initial monotherapy for epileptic seizures and
syndromes.
http://www.ilae.org/Visitors/Documents/Guidelines-epilepsia-12074-2013.pdf
[Accessed April 2013]

5. Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe.
http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf [Accessed
September 2013].

6. Pugliatti M, et al. Epilepsia 2007: 48(12) 2224-2233.

Date of preparation: December 2013 Job code: Zonegran-UK2508

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