Inovelon® (rufinamide) Oral Suspension Formulation Launched in Spain

     Inovelon® (rufinamide) Oral Suspension Formulation Launched in Spain

  PR Newswire

  HATFIELD, England, January 2, 2013

HATFIELD, England, January 2, 2013 /PRNewswire/ --

  Child friendly formulation set to aid administration for the treatment of
                           Lennox-Gastaut syndrome

Inovelon ^® (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 ^® 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 ^®  (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 ^® (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 ^® (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 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/AboutEpilepsy/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

Contact: Media Enquiries: Eisai Europe Ltd, Cressida Robson, +44
(0)7908-314-155, 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
 
Press spacebar to pause and continue. Press esc to stop.