Inovelon®(rufinamide) Oral Suspension Formulation Launched in France

Hatfield, England (ots/PRNewswire) -

Child friendly formulation will help treatment of orphan syndrome
LGS a

severe form of childhood epilepsy

Inovelon(R) (rufinamide) oral suspension for adjunctive (add-on)
treatment of seizures associated with Lennox-Gastaut syndrome (LGS)
in children four years and older is launched today in France. The new
formulation of the orphan drug has been developed as a child friendly
drinkable liquid to aid the administration of treatment.

LGS is one of the most severe forms of childhood epilepsy
accounting for four per cent of epilepsy in children.[1] The rare but
serious condition affects approximately 11,000 children across
Western Europe and the peak age of onset is between ages three and
five.[2] The condition is characterised by multiple daily seizures
and people with the condition can have up to 70 seizures a day.[3]
Two in three individuals with LGS experience at least one prolonged
period of seizure causing confusion and a loss of alertness lasting
from hours to weeks.[4] Most children with LGS also experience
developmental problems leading to impaired intellectual functioning
and behavioural issues.[5] LGS is one of the most drug-resistant
forms of childhood epilepsy and effective management of the condition
is often very difficult, reiterating the importance for children to
adhere to treatments protocols.

"There is a strong need for drinkable medicines especially when
treating younger LGS patients. In addition, the use of the rufinamide
oral suspension allows for individual titration in smaller steps to
find the optimal dose for each patient", said Professor Stephane
Auvin, Epileptologist and Child Neurologist at the Robert Debré
Children's Hospital, Paris, France. "The availability of the
suspension formulation of rufinamide will potentially help young
patients adhere better to treatment which may help improve outcomes
in the management of this severe and highly debilitating disease."

"The launch of Inovelon suspension in France may help improve the
care of children and young people with this severe form of epilepsy.
Improving treatment compliance is a key factor in helping to reduce
seizure frequencies, particularly for young people, and an oral
suspension formulation may help aid compliance", said Bashar Allaf,
Medical Manager for Epilepsy, Eisai France. "Eisai is working closely
with epilepsy centres across the country to ensure the new treatment
is available to people with LGS as soon as possible. This move is
entirely in line with our on-going commitment to improve the lives of
people with epilepsy and their families."

The oral suspension formulation is identical in preparation to the
currently marketed rufinamide tablet on a milligram per milligram
basis. The new suspension was launched in Germany, Denmark, Finland,
Norway, The Netherlands, Sweden, Spain, Austria and the UK. In
addition, it will continue to be launched subsequently in other
European countries. Rufinamide oral suspension received positive CHMP
opinion in September 2011 and formal EMA approval was granted in
November 2011. The preparation was approved by the FDA and launched
in the US in March 2011 (rufinamide is marketed as BANZEL(R) in the
US).

The development of an oral drinkable suspension formulation of
rufinamide demonstrates Eisai's commitment to the therapeutic area of
epilepsy and further exemplifies the company's human health care
(hhc) mission to address the diversified needs of and increase the
benefits provided to patients and their families worldwide.

About Inovelon(R) (rufinamide)

Rufinamide is a triazole derivative that is structurally unrelated
to currently marketed antiepileptic drugs (AEDs). It is believed to
regulate the activity of sodium channels in the brain which carry
excessive electrical charges. The agent was approved for adjunctive
therapy for seizures associated with LGS in Europe (under the brand
name Inovelon) in 2007.[6] Inovelon is available as film-coated
tablets containing 100mg, 200mg, and 400mg rufinamide and as a 40
mg/ml oral suspension. .

The film-coated formulation of rufinamide was first launched in
Europe in May 2007 and is now available in 19 European countries.
Rufinamide oral suspension received EMA approval in November 2011.

About Lennox-Gastaut Syndrome

LGS is a debilitating form of childhood-onset epilepsy that most
often appears between the ages of two and seven years. It is
characterised by frequent and multiple seizure types, and is often
accompanied by mental retardation, and psychological and behavioural
problems.[7]

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 with the condition 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 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 Europe,
the Middle East, Africa and Russia (EMEA).

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

- Zonegran(R) (zonisamide) as monotherapy and adjunctive therapy in adult
patients with partial-onset seizures, with or without secondary generalisation.
(Zonegran is under license from the originator Dainippon Sumitomo Pharma). In
Switzerland, Zonegran is only approved as adjunctive therapy.
- 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). Zebinix is not approved by Swissmedic.
- Inovelon(R) (rufinamide) for the adjunctive treatment of seizures associated
with Lennox-Gastaut Syndrome in patients >4 years
- 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

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, and inflammatory bowel disease

With operations in the U.S., Asia, Europe and its domestic home
market of Japan, Eisai employs more than 11,000 people worldwide.
From its Europe based Knowledge Centre in Hatfield, UK, Eisai has
recently expanded business operations to include the expanded
territory of Europe, the Middle East, Africa and Russia (EMEA). Eisai
EMEA 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, the Netherlands,
Belgium, Luxembourg, the Middle East and Russia.

For further information please visit: http://www.eisai.com

References

1. http://ghr.nlm.nih.gov/condition/lennox-gastaut-syndrome

2. http://www.epilepsyfoundation.org/aboutepilepsy/syndromes/lenno
xgaustaut/index.cfm

3. http://www.specialchild.com/archives/dz-017.html

4. NINDS Lennox-Gastaut information page. National Institute of
Neurological Disorders Web site. http://www.ninds.nih.gov/disorders/l
ennoxgastautsyndrome/lennoxgastautsyndrome.htm. Updated June 15,
2010. Accessed March 28, 2011.

5. MedScape references Lennox-Gastaut Syndrome
http://emedicine.medscape.com/article/1176735-overview (Accessed
February 2012)

6. Inovelon tablets Summary of Product Characteristics
http://www.medicines.org.uk/emc/medicine/20165/SPC
[http://www.medicines.org.uk/emc/medicine/20165/SPC ] (Accessed
January 2012)

7. International Journal of Pharma and Bio Sciences.
http://www.ijpbs.net/issue-3/82.pdf (Accessed February 2012)

8. Epilepsy in the WHO European Region: Fostering Epilepsy Care in
Europe
http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf
[http://www.ibe-epilepsy.org/downloads/EURO Report 160510.pdf ]
(Accessed August 2012)

9. Pugliatti M, et al. Epilepsia Estimating the cost of epilepsy
in Europe: a review with economic modelling. 2007: 48(12);2224-2233

Date of preparation: March 2013

Job code: Inovelon-EU0007
[https://www.zincmapseisai.com/Jobs/JobView.aspx?Job.Id=10382 ]

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

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: Siobhan Reilly/Moira Gitsham, +44-(0)-2077989999 /
+44-(0)-207798900, Siobhan.Reilly@toniclc.com,
eisaiepilepsy@toniclc.com