Eisai Europe Limited

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)

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



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