Eisai Technology Transfer

Partnership Objective

Provision of high-quality Eisai products at affordable price to emerging and developing country markets.

Technology transfer to the Eisai Vizag facility in India. Technology transfer to the Eisai Vizag facility in India. Copyright Eisai

What are the health needs and challenges?

Many people in emerging and developing countries do not have sufficient access to high quality medicinal products at affordable prices. Technology transfer and local manufacturing in developing countries helps Eisai implement its Affordable Pricing Policy, which seeks to allow the company to “supply products in a sustainable manner at prices affordable to the patients in need of our drugs”.

Description of partnership activities and how they address needs and challenges

Eisai Vizag plant, one of Eisai’s factories, was established in Andhra Pradesh, India, in December, 2009. Eisai Vizag plant is a high-quality, low-cost manufacturing facility with high cost-competitiveness, supplying medicinal products mainly to emerging and developing countries. GMP (Good Manufacturing Practice) audits, training and technology transfers by teams of experts mainly from Eisai Japan, as well as Eisai US and Eisai Europe are currently ongoing, as this plant also supplies products to developed world markets. It is also taking a role as the manufacturing site of the 2.2 billion diethylcarbamazine citrate (DEC) tablets, an anti-filarial medication which will be provided to WHO at “price zero” until 2020. The packaging label on the bottle is written in four languages (English, French, Spanish, and Portuguese) to make people living in at-risk communities comfortable with taking the medicine. Eisai plans to deliver this medicine through the WHO's lymphatic filariasis elimination program to some 250 million people in the developing world by 2020. 

Before establishing Eisai Vizag plant, Eisai specialists in the areas of manufacturing, quality control and plant design were selected. Eisai Vizag plant management personnel were then recruited in India and the plant was designed through many discussions among specialists from India and Japan. For manufacturing technology transfer, those highly competent in formulation development were selected from each of the three Eisai plants in Japan and sent to Vizag. Technology transfer documents, with the details of the manufacturing and testing methods and the regulatory approvals, provided from Eisai Japan to Eisai vizag plant, were very useful for smooth technology transfer. Frequent communications were begun among Vizag and other plants in Japan, the US and Europe in Eisai, mainly with regard to the specifications of raw materials, which significantly contributed to stable manufacturing of high quality products.

Lessons learned

Eisai staff with a strong sense of mission to provide high quality products at lower prices were actively involved and transferred sufficient knowledge and technology to Eisai Vizag plant, whose staff shared this sense of mission and responded well to expectations. To make technology transfer successful, a great deal of knowledge needs to be properly and effectively communicated.

Summary of impact and forward looking information

Eisai received prequalification from the WHO for DEC 100 mg tablets manufactured at its Vizag Plant for the treatment of lymphatic filariasis, Eisai Vizag plant developed the formulation of DEC tablets from scratch, and Eisai conducted bioequivalence studies before submitting its application to the World Health Organization (WHO) for prequalification in October 2012. After a relatively smooth evaluation process, Eisai was able to receive prequalification for the DEC tablets less than 10 months from submission of the application. Finally, Eisai could begin the free supply of DEC tablets produced at its Vizag Plant in India to eliminate lymphatic filariasis in targeted developing and emerging countries in October 2013.

Videos

Tackling Lymphatic Filariasis

Partnership information

Company(ies) Eisai

Partner(s) Vizag Plant, World Health Organization (WHO)

Type of Partner(s) IGOs, Other Business

Therapeutic Focus Neglected Tropical Diseases

Disease(s) Lymphatic Filariasis

Program Type(s) Availability of Treatment - Differential Pricing, Availability of Treatment - Product Donations, Availability of Treatment - Technology Transfer - Manufacturing and Entrepreneurial Know-How

Targeted Population(s) Children, Elderly, Marginalised / Indigenous People, Men, Mothers, People with low income, Women, Youth

Region(s) East Asia & Pacific, Latin America & Caribbean, Middle East & North Africa, South Asia, Sub-Saharan Africa

Number of Countries 23

Country(ies) Bangladesh, Brazil, Comoros, Dominican Republic, Egypt, Fiji, Haiti, India, Indonesia, Kenya, Kiribati, Lao PDR, Malaysia, Micronesia, Nepal, Papua New Guinea, Samoa, Sao Tome and Principe, The Gambia, Timor-Leste, Tuvalu, Zambia, Zimbabwe

Research Country(ies) India, Japan

Start Date 2009

More information Eisai Access to Medicines

Anticipated completion date Ongoing