Eisai Celebrates Launch of new Belgium Operation

HATFIELD, England, September 16, 2013 /PRNewswire/ --

First drug reimbursement submission for new office is Halaven^®(eribulin), a novel treatment for advanced breast cancer  

Eisai EMEA (Europe, Middle East, Africa, Russia and Oceania), a division of one of the world's leading research and development (R&D) based pharmaceutical companies, has opened a new business operation in Belgium with an office based in Brussels.

The Belgium office will be responsible for marketing Eisai's Inovelon^® (rufinamide), indicated as an adjunctive therapy in the treatment of epileptic seizures associated with Lennox-Gastaut syndrome (LGS) in patients 4 years and older,^[1] which has been commercially available in Belgium since March 2012. Rufinamide was granted orphan drug status for adjunctive treatment of patients with this particularly hard-to-treat syndrome in October 2004.

Eisai has submitted Halaven^® (eribulin), an innovative metastatic breast cancer (MBC) treatment, for local reimbursement approval by INAMI/RIZIV in Belgium. Eribulin received European Commission approval in March 2011 and is indicated for the treatment of patients with locally advanced or MBC who have progressed after at least two chemotherapeutic regimens for advanced disease. Prior therapy should have included an anthracycline and a taxane unless women were not suitable for these treatments.^[2]  

Commenting on the submission of eribulin for reimbursement approval in Belgium, Nicolas Kormoss, M.D., Medical Director for Belgium and Luxemburg, Eisai EMEA said: "Belgium has one of the highest rates of breast cancer in the world, with around 2,500 women dying from breast cancer every year. We hope the local health authorities recognise the clinical value that Halaven could bring to those in the country with advanced breast cancer."^[3]

The Belgium office opening comes as part of Eisai's globalisation strategy set out in its mid-term strategic plan in 2011 "HAYABUSA", in which the company seeks to expand its global presence by 2015 in an effort to achieve its objective to make contributions to more than 500 million patients worldwide.

Commenting on the opening of the new Belgium office Gary Hendler, President and CEO, Eisai EMEA said: "We are delighted to open an Eisai office in such a key European market, both to support Inovelon and to provide a solid base for the launch of Halaven in the future."

Eisai is committed to developing and delivering highly beneficial new treatments to help improve the lives of people with cancer and epilepsy, and their families. The continued development of its oncology and epilepsy portfolios underscores Eisai's human health care mission, the company's commitment to innovative solutions in disease prevention, cure and care for the health and wellbeing of people worldwide.

Notes to Editors

Eisai in Oncology

Our commitment to meaningful progress in oncology research, built on scientific expertise, is supported by a global capability to conduct discovery and preclinical research, and develop small molecules, therapeutic vaccines, and biologic and supportive care agents for cancer across multiple indications.

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, Russia and Oceania (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 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, and the Middle East.

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

References
1. Eisai Ltd 2013. Inovelon Summary of Product Characteristics [http://www.medicines.org.uk/emc/medicine/20165/SPC/Inovelon+Tablets+and+Oral+Suspension ] (last updated August 2013)
2. Eisai Ltd 2013. Halaven Summary of Product Characteristics [http://www.medicines.org.uk/emc/medicine/24382/SPC/Halaven+0.44+mg+ml+solution+for+injection ] (last updated April 2013)
3. Globocan 2008 statistics. http://globocan.iarc.fr/factsheet.asp#WOMEN [http://globocan.iarc.fr/factsheet.asp ]. Last accessed July 2013.

Date of preparation: September 2013
Job code: Corporate-UK2016