All Wales Strategic Medical Group and Scottish Medicines Consortium Accept use of Inovelon® (rufinamide) Drinkable, Child

All Wales Strategic Medical Group and Scottish Medicines Consortium Accept use
       of Inovelon® (rufinamide) Drinkable, Child-friendly Formulation

  PR Newswire

  HATFIELD, England, November 6, 2012

HATFIELD, England, November 6, 2012 /PRNewswire/ --

 New option provides choice for children and young people with Lennox-Gastaut

                          a severe form of epilepsy

The All Wales Strategic Medical Group (AWSMG) and Scottish Medicines
Consortium (SMC) has accepted the use of Inovelon ^® (rufinamide) oral
suspension for the adjunctive treatment of seizures associated with
Lennox-Gastaut syndrome (LGS), a highly debilitating form of epilepsy, in
children four years and older in Wales and Scotland. The AWSMG and SMC have
restricted its use to patients who have failed treatment with, or are
intolerant of, other antiepileptic drugs. ^[1] ^, ^[2]

The AWSMG and SMC's decision to accept the use of rufinamide oral suspension
follows their approval of the tablet formulation in 2008 based on data showing
that it can significantly reduce the frequency of total and tonic-atonic
seizures, and significantly improve seizure severity, when compared to placebo
in patients with LGS. ^[ ^3] The oral suspension was shown to be bioequivalent
and cause minimal budget impact in Scotland and Wales, and was therefore
subsequently approved following an abbreviated submission. Many patients who
receive the orphan drug rufinamide are children and this new formulation has
been developed as a child-friendly, orange-flavoured 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," said
Helen Cross, Head of Neuroscience Unit, University College London, Institute
of Child Health. "Access to the suspension formulation of rufinamide may
potentially help young people adhere better to treatment and ultimately may
lead to improved outcomes in the management of this severe and highly
debilitating disease."

LGS is a severe, rare form of epilepsy accounting for five percent of all
cases and rising to approximately 10 percent of childhood epilepsy cases. ^[4]
The annual incidence of the condition affects up to 2.8 per 10,000 births in
Europe. ^[ ^4 ^] Treatment adherence is key to effective LGS management in
children as the disease is characterised by multiple daily seizures, mental
retardation and regression. ^[5]

"The AWSMG and SMC's approval of the new drinkable form of rufinamide is
important as it may help address the adherence needs of children and young
people with this severe form of epilepsy," said Mike Bee, Epilepsy Business
Unit Director, EU North. "These approvals are in line with our on-going
commitment to the therapeutic area of epilepsy and exemplifies our drive to
increase the benefits our medicines provide patients and their families
through Eisai's human health care (hhc ) mission."

The oral suspension is dose equivalent to the currently marketed rufinamide
tablet on a milligram per milligram basis. The AWSMG and SMC approval for the
use of the oral suspension follows launches of the medicine in the UK, The
Netherlands and Germany. Other European countries will launch the new
formulation later this year.

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 ^® in the US). 

                                   - ENDS -

About Inovelon ^®  (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 ^] Rufinamide 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

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. ^[6]

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, 10.5 million of which are
children under the age of 15. ^[ ^7] ^, ^[ ^8] ^, ^[ ^9] In Scotland it
affects nearly 40,000 people. ^[ ^10]

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. ^[ ^11]

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 ^® (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)
  *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
  *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 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
  *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 .


1.Scottish Medicines Consortium. Inovelon product update.
. Last accessed 3 September 2012

2.All Wales Strategic Medicines Group. Inovelon product update.
. Last accessed 2 November 2012

3.Inovelon tablets Summary of Product Characteristics . (Accessed January 2012)

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

5.MedScape references Lennox-Gastaut Syndrome (Accessed February

6.International Journal of Pharma and Bio Sciences. (Accessed February 2012)

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

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

9.Epilepsy Society UK:
(Accessed February 2012)

10. Epilepsy Scotland available at:
(Accessed 01 November 2010).

11. Epilepsy Research UK. What is Epilepsy? Fact sheet. Available from URL: (Accessed
February 2012)

Date of preparation: November 2012 Job code: Inovelon-UK2271

Contact: Media Enquiries: Eisai Europe Ltd, Charlotte Andrews / Cressida
Robson, +44-(0)7947-231513/ +44-(0)790-831-4155, /; Tonic Life Communications, Benjamyn Tan / Hollie
Matthews, +44-(0)207-798-9262 / +44-(0)207-798-9992,
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