Inovelon® (rufinamide) Drinkable Suspension Launches in Denmark

Hatfield, England (ots/PRNewswire) -

Child-friendly formulation now available for the treatment
of Lennox-Gastaut

syndrome

Eisai Europe Limited today announced the launch of Inovelon(R)
(rufinamide) oral suspension in Denmark for adjunctive (add-on)
treatment of seizures associated with Lennox-Gastaut syndrome (LGS),
in children four years and older. Many patients who receive the
orphan drug rufinamide are children, creating a need for a
child-friendly, drinkable liquid to aid administration of treatment.

"We are glad that the drinkable suspension formulation of
rufinamide is now available in Denmark for this severe, rare form of
epilepsy. Access to this formulation means that patients and their
carers will now have a choice in the administration of their
treatment. Some patients, particularly children, find conventional
tablets difficult to swallow and this drinkable formulation could
result in better treatment adherence. In addition, this new
suspension formulation allows for individual titration in small steps
to find the optimal dose for each patient", said Professor Marina
Nikanorova, Danish Epilepsy Centre.

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 up to 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]

"Our focus has been to address the needs of children and young
people with LGS. Launching the oral suspension formulation means that
we are able to support these patients who find swallowing tablets a
challenge. Making this formulation available in these regions could
make LGS treatment easier and help compliance which is one of the key
factors in reducing seizure frequencies particularly for young people
with severe epilepsy. Eisai is now working closely with epilepsy
centres in each of the countries to ensure this treatment is
available to patients as soon as possible", said Mike Bee, Epilepsy
Business Unit Director, EU North.

The oral suspension is dose equivalent to the currently marketed
rufinamide tablet on a milligram per milligram basis. The new
suspension was launched in Germany and Austria in March and in the UK
in April. The suspension formulation will 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 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.It is available in some countries
as an oral suspension in orange flavour 40mg/ml concentration. The
oral suspension formulation is bioequivalent to the tablet
formulation on a milligram per milligram basis. The formulation is
bioequivalent to the already available tablet formulation on a
milligram per milligram basis.

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 the European market.

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)
- 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 the adjunctive treatment of seizures associated
with Lennox-Gastaut Syndrome in patients >4 years

About Eisai

Eisai is one of the world's leading R&D-based pharmaceutical
companies and has defined its 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
recently expanded their UK Hatfield facility which now supports the
company's growing European, Middle Eastern and African (EMEA)
business.

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

- Neuroscience, including: Alzheimer's disease, multiple sclerosis,
neuropathic pain, epilepsy, depression
- Oncology including: anticancer therapies; tumour regression, tumour
suppression, antibodies, etc and supportive cancer therapies; pain relief, nausea
- Vascular/Immunological reaction including: acute coronary syndrome,
atherothrombotic disease, rheumatoid arthritis, psoriasis, Crohn's 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, and
Belgium.

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 (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/AboutEp
ilepsy/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)

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

Contact:
Media Enquiries, Eisai Europe Ltd, Charlotte Andrews / Cressida
Robson, +44-(0)7947-231513 / +44-(0)-790-831-4155,
charlotte_andrews@eisai.net / cressida_robson@eisai.net ; Tonic Life
Communications, Benjamyn Tan / Leah Peyton, +44-(0)-207-798-9262 /
+44-(0)-7788-191434, benjamyn.tan@toniclc.com /
leah.peyton@toniclc.com