Inovelon® (rufinamide) Oral Suspension Formulation Launched in Spain

Hatfield, England (ots/PRNewswire) -

Child friendly formulation set to aid administration for the
treatment of

Lennox-Gastaut syndrome

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 Spain. As many
patients who receive the orphan drug rufinamide are children, the new
formulation has been developed as a child friendly drinkable liquid
to aid the administration of treatment.

"As some children find tablets difficult to swallow, 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 Dr. Juan Jose Garcia Peñas,
Neuropediatrician at the Hospital Infantil Universitario Niño Jesus.
"The availability of the suspension formulation of rufinamide will
potentially help young patients adhere better to treatment which
should help improve outcomes in the management of this severe and
highly debilitating disease."

LGS is a rare form of epilepsy accounting for five percent of all
cases and rising to approximately 10 percent of childhood epilepsy
cases.[1] The annual incidence of the condition affects about 2.8 per
10,000 births in Europe.[1] Effective LGS management and compliance
to treatment is of key importance to children as the condition is
characterised by multiple daily seizures, mental retardation and
regression.[2]

"The launch of the new drinkable form of rufinamide in Spain will
help address the needs 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", said Antonio Rodriguez Gallego, Brand Manager EPBU, Eisai
Farmaceutica, S.A. "Eisai is working closely with epilepsy centres in
Spain to ensure the new treatment is available to patients as soon as
possible. This move is entirely in line with our on-going commitment
to the therapeutic area of epilepsy and our drive to increase the
benefits provided to patients and their families of our medicines
through Eisai's human health care (hhc) mission."

The oral suspension is identical in preparation to the currently
marketed rufinamide tablet on a milligram per milligram basis.
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 in the therapeutic area of
epilepsy and further exemplifies the company's contribution to
addressing the diversified needs of and increasing the benefits
provided to patients and their families as shown by its human health
care (hhc) mission.

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 LGS in Europe (under the brand name Inovelon) in 2007.[3]
Inovelon is available as film-coated tablets containing 100mg, 200mg,
and 400mg rufinamide.

The film-coated formulation of rufinamide was first launched in
Europe in May 2007 and is now available in 19 European countries.

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.[4]

About Epilepsy

Epilepsy is one of the most common neurological conditions in the
world, affecting approximately eight in 1,000 people in Europe.[5]
There are an estimated six million people living with epilepsy in
Europe[6] and estimated 50 million people worldwide[7] - 10.5 million
of which are children under the age of 15.[8]

Epilepsy is characterised by abnormal firing of impulses from nerve
cells in the brain causing seizures. Depending on the seizure type,
seizures may be limited to one part of the body, or may be
generalised to involve the whole body.

Patients may also experience abnormal sensations, altered behaviour
or altered consciousness. Epilepsy is a disorder with many possible
causes. Often the cause of epilepsy is unknown. However, anything
that disturbs the normal pattern of neuron activity - from illness to
brain damage to tumours, can lead to seizures.[9]

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 anti-epileptic drugs (AEDs) is a major strategic area
for Eisai in Europe, the Middle East, Africa and Russia (EMEA).

In Europe, Eisai currently has three marketed treatments including:

- Zonegran(R) (zonisamide) as adjunctive therapy in adult patients 
with
  partial-onset seizures, with or without secondary generalisation. 
(Zonegran is under
  license from the originator Dainippon Sumitomo Pharma). Eisai has 
applied for the
  marketing authorisation for zonisamide as monotherapy for newly 
diagnosed epilepsy
  patients with partial seizures, with or without second 
generalisation
- 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)
- Inovelon(R) (rufinamide) for adjunctive treatment, 4 years and 
older of
  seizures associated with Lennox-Gastaut Syndrome

About Eisai

Eisai recently expanded their UK Hatfield commercial, research and
manufacturing facility which now supports the company's growing EMEA
business.

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 11,000 people worldwide. In
Europe, Eisai 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 our web site
http://www.eisai.com.

References

1. Kenou van Rijckevorsel Treatment of Lennox-Gastaut syndrome:
overview and recent findings. Neuropsychiatr Dis Treat. 2008
December; 4(6): 1001-1019.

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

3. 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)

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

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

6. ILAE/IBE/WHO, Epilepsy in the WHO European Region: Fostering
Epilepsy Care in Europe 2010. Available from;
http://www.ilae-epilepsy.org/Visitors/Documents/EUROReport160510.pdf
(Accessed February 2011)

7. Epilepsy Society UK: http://www.epilepsysociety.org.uk/AboutEpilep
sy/Whatisepilepsy/Epilepsy-didyouknow (Accessed February 2012)

8. Forsgren L. Epilepsy in Children. 2nd Ed London. Arnold, 2004.
21-25

9. Epilepsy Research UK. What is Epilepsy? Fact sheet. Available from
URL: http://www.epilepsyresearch.org.uk/about_us/leaflets/lflt1.htm
(Accessed February 2012)

Date of preparation: January 2013

Job code: Inovelon-UK2277

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