Eisai Files First Products in South Africa

HATFIELD, England, January 29, 2013 /PRNewswire/ --

Expansion into Africa with the filing of two products

Eisai announces the expansion of its operations into South Africa, with the filing of its two products - Halaven® (eribulin) for metastatic breast cancer and Fycompa® (perampanel) for epilepsy to The Medicines Control Council (MCC).

The South African government has set out plans to introduce a universal healthcare system with the public health budget growing considerably.^[1] The South African pharmaceutical market is also expected to double in the next six years.^[2] Eisai's continued growth is part of the company's Hayabusa plan to have a presence in the top 20 pharmaceutical markets and deliver effective treatments to more than 500 million patients by 2015.

"Eisai has been successfully operating in Europe for more than 20 years and we are proud to be bringing effective medicines to countries outside this region," said Gary Hendler, President and CEO of Eisai Europe, Middle East, Africa and Russian (EMEA) business. "The filing of Halaven and Fycompa in South Africa shows our commitment to our expansion plans to provide effective treatments to more patients around the world. This also further validates our human health care (hhc) mission to satisfy unmet medical needs and contribute to the health and well-being of people worldwide."

In South Africa an estimated 8,000 South African women are diagnosed with breast cancer every year and it is predicted that 20% will die from the disease.^[3] The filing of eribulin in South Africa is a step closer to giving women with metastatic breast cancer access to a treatment with proven significant overall survival benefit compared to other single agent chemotherapies, as demonstrated by the EMBRACE Study.^[4] The filing of eribulin in South Africa is based on data obtained from the EMBRACE Study. Since the launch of eribulin in Europe, it has given heavily pre-treated women with metastatic breast cancer precious additional time with their loved ones.

Discovered and manufactured by Eisai, perampanel has been approved by the European Commission (EC) and is now available in the UK, Germany, Austria, Denmark, Sweden and Norway as an adjunctive therapy for patients with partial-onset seizures (the most common form of epilepsy) aged 12 years and above. Eisai expects the availability of perampanel in South Africa in will be a significant step for people with epilepsy, as successful control of partial-onset seizures remains a challenge. An estimated 1 in 100 people have epilepsy in South Africa.^[5]

Notes to Editors

About Eisai's Commitment to Improving Global Access to Medicines

Today, it is estimated that some 2.7 billion* people around the world live on US$2 or less per day. Most of these 2.7 billion people do not have access to essential health care and treatment despite the availability of effective medicines. This is an international challenge that needs to be solved through collaborations among governments, international organisations such as the WHO, non-governmental organisations and pharmaceutical companies.

In line with its human health care (hhc) mission, Eisai is committed to improving global access to medicines over the medium-to-long term through partnership strategies that involve working with governments, international organisations, private entities and non-profit organisations. Specifically, the company has developed and is implementing a five-target approach to improve access to medicines worldwide. The five key components are: product creations, strategic solutions, capacity building, quality innovation, and long-term investment.

For further information on Eisai's Access to Medicines initiatives, please visit the Access to Medicines page on the Eisai Global website: http://www.eisai.com/company/atm/index.html

* Source: World Bank (2005)

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, and 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. From its Europe based Knowledge Centre in Hatfield, UK, Eisai has recently expanded business operations to include the expanded territory of Europe, the Middle East, Africa and Russia (EMEA). Eisai EMEA 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: http://www.eisai.com

1. http://www.bbc.co.uk/news/world-africa-14504628 (Last accessed Nov 2012)

2. http://www.africanbusinessreview.co.za/money_matters/south-africas-pharmaceutical-market-booms

3. BATEMAN, Chris. Breast cancer breakthrough in gene profilings?. SAMJ, S. Afr. med. j. [online]. 2009, vol.99, n.11, pp. 780-782. http://www.scielo.org.za/scielo.php?pid=S0256-95742009001100009&script=sci_arttext (Last accessed Nov 2012)

4. Cortes J, O'Shaughnessy J, Loesch D, et al. Eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. The Lancet. 2011; 377: 914 -923

5. http://www.epilepsy.org.za/epsa/faq.php#what [http://www.epilepsy.org.za/epsa/faq.php ] (Last accessed Nov 2012)

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January 2012