Eisai Announces New Partnership with Esteve to Promote Anti-epilepsy Drug Zonegran® (Zonisamide) in Spain

HATFIELD, England, December 10, 2013 /PRNewswire/ --

Eisai announces today that it has selected Esteve, a Spanish pharmaceutical company with a comprehensive neurology franchise, to become its epilepsy partner in Spain to promote Zonegran^® (zonisamide). Zonisamide, a novel anti-epileptic drug (AED) with multiple mechanisms of action and a chemical structure unrelated to any other AED, is indicated 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 secondary generalisation, in adults, adolescents and children aged six years and above.^[1]

"As a research-based pharmaceutical company with a particular focus on epilepsy, we are not only committed to bringing innovative new therapies to market, but also ensuring that we maximise access to our currently licensed products," comments Gary Hendler, President and CEO, Eisai EMEA. "Our partnership with one of Spain's leading pharmaceutical companies, Esteve for Zonegran in Spain will allow Eisai to focus our efforts and resources on a broad epilepsy portfolio, and we believe strongly that our new promotion strategy will allow us to become the leading company in epilepsy by 2015."

"The alliance in epilepsy between Esteve and Eisai is a new milestone for our company and will allow us to foster and consolidate our presence in one of our core business areas: central nervous system" explains Albert Esteve, CEO of Esteve.

Epilepsy is a common neurological condition that causes recurrent seizures in the brain.^[2] It is usually diagnosed in children and people over 65 years of age, although it can affect anyone.^[2] Currently, up to 22,000 people are diagnosed with epilepsy each year in Spain, of whom around one third have seizures that are not completely controlled by their anti-epileptic therapy.^[3]

The new partnership with Esteve in Spain is yet another example of Eisai's human health care mission. Eisai is committed to the therapeutic area of epilepsy and addressing the unmet medical needs of people with epilepsy. Eisai is proud to currently market more epilepsy products in EMEA than any other company, and is dedicated to becoming the number one epilepsy company in Europe (by sales) by 2015, as stated in its Hayabusa plan.

*** ENDS ***

Notes to Editors

About Zonegran (zonisamide)

Zonisamide is licensed in Europe as monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy. Zonisamide is also indicated as adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults, adolescents and children aged six years and above.^[1] It has a broad spectrum of anti-epileptic modes of action and has no appreciable effects on steady-state plasma concentrations of other AEDs, such as phenytoin, carbamazepine and valproate.^[1] Zonegran is one of only four AEDs with level A efficacy/effectiveness evidence as initial monotherapy for adults with partial onset seizures.^[4]

Zonisamide is available in 25mg, 50mg, and 100mg capsule strengths. The recommended initial daily dose for monotherapy use is 100mg once daily. In the third and fourth weeks the dose may be increased to 200mg daily and then increased to 300mg daily after the next two weeks.The recommended initial daily dose for adjunctive use is 50mg in two divided doses. After one week the dose may be increased to 100 mg daily and thereafter the dose may be increased at weekly intervals, in increments of up to 100 mg.^[1]

For more information please visit: http://www.zonegran.eu

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.^[5],[6] 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

About Esteve

Esteve is a leading pharmaceutical chemical group based on Barcelona, Spain. Since it was founded in 1929, Esteve has been firmly committed to excellence in healthcare, dedicating efforts to innovative R&D of new medicines for unmet medical needs and focusing on high science and evidence-based research. Esteve has a strong partnership approach to drug discovery, development and commercialisation. The company works both independently and in collaboration to bring new, differentiated best-in-class treatments to patients who need them. The company currently has a team of about 2300 professionals, and has subsidiaries and production facilities in several European countries, USA, China and Mexico.

For further information, please visit http://www.esteve.com

References

1. Eisai Ltd 2013. Zonegran summary of product characteristics (last updated October 2013) https://www.medicines.org.uk/emc/history/16240/SPC/Zonegran+25,+50,+100+mg+Hard+Capsules

2. Epilepsy Research UK. What is Epilepsy? Factsheet. Available from URL: http://epilepsyresearch.org.uk/wp-content/uploads/2012/03/1_what_is_epilepsy.pdf (Last accessed May 2013)

3. García-Ramos R, et al. Neurología. 2011; 26:548-55. http://www.elsevier.es/sites/default/files/elsevier/eop/S2173-5808(11)00042-3.pdf (Last accessed May 2013)

4. Glauser T. et al. Updated ILAE evidence review of antiepileptic drug efficacy and effectiveness as initial monotherapy for epileptic seizures and syndromes. http://www.ilae.org/Visitors/Documents/Guidelines-epilepsia-12074-2013.pdf [Accessed April 2013]

5. Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe. http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf [Accessed September 2013].

6. Pugliatti M, et al. Epilepsia 2007: 48(12) 2224-2233.

Date of preparation: December 2013
Job code: Zonegran-UK2508