Inovelon® (Rufinamide) Oral Suspension Formulation Launched in Portugal

HATFIELD, England, December 17, 2013 /PRNewswire/ --

PRESS RELEASE NOT FOR U.S. MEDIA

Child friendly formulation will help treatment of orphan syndrome LGS, a severe form of childhood epilepsy

Inovelon^® (rufinamide) oral suspension for adjunctive (add-on) treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in children four years and older has launched in Portugal.^[1] The new formulation of the orphan drug has been developed as a child friendly drinkable liquid to aid the administration of treatment.

"The availability of the suspension formulation of rufinamide in Portugal will potentially help young patients adhere better to treatment, which may help improve outcomes in the management of this severe and highly debilitating condition," commented Dr. Pedro Cabral, Neuropaediatrician, Director Clinico do CADIn, Cascais, Portugal.

LGS is one of the most severe forms of childhood epilepsy and accounts for 5% of epilepsy in children,^[2] with the peak of onset at between ages three and five.^[3] LGS is characterised by multiple daily seizures and people with the condition can have up to 70 seizures a day.^[4] Most children with LGS also experience developmental problems leading to impaired intellectual function and behavioural issues.^[5] LGS is one of the most drug-resistant forms of childhood epilepsy and effective management of the condition is often very difficult, reiterating the importance for children to adhere to treatment protocols. Results from a double-blind, randomised, placebo-controlled trial of rufinamide demonstrate a reduction in tonic-atonic ('drop attack') seizure frequency of 42.5% compared to placebo.^[6]

"We are pleased to announce the launch of the Inovelon oral suspension formulation in Portugal for those with LGS, and hope that it may help improve treatment compliance in children and young people with this severe form of epilepsy," commented Miguel Marcão, Managing Director for Spain and Portugal, Eisai Farmaceutica Lda. "Eisai is working closely with epilepsy centres across the country to ensure the new treatment is available to those who need it as soon as possible, in line with our ongoing commitment to improve the lives of people with epilepsy and those of their families."  

The rufinamide oral suspension formulation 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 launched in Germany in March 2012.

The development of an oral suspension formulation of rufinamide demonstrates Eisai's commitment to the therapeutic area of epilepsy and further exemplifies the company's human health care (hhc) mission to address the diversified needs of and increase the benefits provided to patients and their families worldwide.

Notes to Editors

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 seizures associated with LGS in Europe (under the brand name Inovelon) in 2007.^[1] Rufinamide is available as film-coated tablets containing 100mg, 200mg, and 400mg rufinamide and as a 40 mg/ml oral suspension.

The film-coated formulation of rufinamide was first launched in Europe in May 2007 and is now available in 19 European countries. Rufinamide oral suspension received EMA approval in November 2011.

About Lennox-Gastaut Syndrome

Lennox-Gastaut syndrome, or LGS, is a rare form of childhood-onset epilepsy which usually appears between the ages of three and five.^[3] The syndrome is characterised by frequent seizures and multiple seizure types, behaviour issues, mental retardation, regression, and a resistance to medications or therapies.^[2]

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 worldwide.^[7],[8] 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.

About Eisai EMEA 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, Russia and Oceania (EMEA).

In the EMEA region, Eisai currently has four marketed treatments including:

• 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
• Zonegran^® (zonisamide) as monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy and as adjunctive therapy in the treatment of partial seizures, with or without generalisation, in adults, adolescents and children aged six years and above. (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 (Rufinamide was originally developed by Novartis)

About Eisai

Eisai is one of the world's leading research and development (R&D) based pharmaceutical companies and we define our 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 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 10,000 people worldwide. From its EMEA Knowledge Centre in Hatfield, UK, Eisai has recently expanded its business operations to include Europe, the Middle East, Africa, Russia and Oceania (EMEA). Eisai EMEA has sales and marketing operations in over 20 markets, including the United Kingdom, France, Germany, Italy, Spain, Switzerland, Sweden, Ireland, Austria, Denmark, Finland, Norway, Portugal, Czech Republic, Slovakia, the Netherlands, Belgium, Russia and the Middle East.

For further information please visit our web site http://www.eisai.co.uk

References

^[1] SPC Inovelon (updated August 2013). Available at: http://www.medicines.org.uk/emc/medicine/20165/SPC/Inovelon+Tablets+and+Oral+Suspension [Last accessed November 2013]

^[2] Tyagi, S. et al. International Journal of Pharma and Bio Sciences. Pharmacological Management of Lennox-Gastaut Syndrome - a difficult to treat form of childhood epilepsy: an overview. 2012. Available at: http://www.ijpbs.net/issue-3/82.pdf [Last accessed November 2013]

^[3] Epilepsy Foundation. Lennox-Gastaut syndrome. Available at:  http://www.epilepsyfoundation.org/aboutepilepsy/syndromes/lennoxgaustaut/index.cfm [Last accessed November 2013]

^[4] Special Child. Lennox-Gastaut syndrome. Available at: http://www.specialchild.com/archives/dz-017.html [Last accessed November 2013]

^[5] US National Library of Medicines. Lennox-Gastaut syndrome. Available at: http://ghr.nlm.nih.gov/condition/lennox-gastaut-syndrome [Last accessed November 2013]

^[6] Glauser, T, et al. Rufinamide for generalized seizures associated with Lennox-Gastaut syndrome. Neurology. 2008;70:1950-1958.

^[7] Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe. http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf [Last accessed November 2013]

^[8] Pugliatti M, et al. Epilepsia 2007: 48(12) 2224-2233.

Date of preparation: December 2013

Job code: Inovelon-UK2287