Eisai Receives Prequalification from WHO for Lymphatic Filariasi

Eisai Receives Prequalification from WHO for Lymphatic Filariasis Medcine
Supply from Vizag Plant, India to 24 Endemic Countries to Begin This Year 
Tokyo, Aug 27, 2013 - (JCN Newswire) -  Eisai Co., Ltd. announced today that it
has received prequalification from the World Health Organization (WHO) for
diethylcarbamazine citrate (DEC) 100 mg tablets manufactured at its Vizag Plant
in India for the treatment of lymphatic filariasis, a neglected tropical
disease (NTD). The approval is the first case worldwide in which a
pharmaceutical company has received prequalification from WHO for a medicine
used to treat an NTD. 
Eisai is a signatory to the London Declaration, which is the largest global
public-private partnership to date and aims to eliminate ten NTDs by 2020. The
lymphatic filariasis medicine DEC is in short supply worldwide, which poses a
major obstacle in eliminating the disease. As part of Eisai's commitment
under the declaration, the company has agreed to produce 2.2 billion
high-quality DEC tablets at the Vizag Plant and, from 2013, to work with WHO to
supply the tablets at price zero to endemic countries over a seven-year period.
Based on this initiative, Eisai developed the formulation and conducted
bioequivalence studies before submitting its application to 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. 
The prequalification is a crucial milestone that will see Eisai deliver
"Eisai-original," high-quality DEC tablets to 250 million people
living in at-risk communities in countries where lymphatic filariasis is
endemic, thereby contributing to successful elimination of the disease. In
2013, Eisai will begin providing DEC tablets produced at the Vizag Plant to WHO
for use in mass drug administration programs in each endemic country. 
In this era of great globalization, Eisai considers its contributions to the
economic development and expansion of the middle-income class through the
enhancement of health and welfare in developing and emerging countries as a
form of long-term investment for future market growth. Eisai remains actively
committed to addressing issues in global health including NTDs, in order to
better contribute to increasing the benefits provided to patients and their
families worldwide. 
About Neglected Tropical Diseases (NTDs) 
According to the World Health Organization (WHO), NTDs blight the lives of
more than 1 billion of the world's poorest 2.7 billion people. There are
149 countries and territories where NTDs are endemic, at least 100 of which are
endemic for 2 or more of these diseases, and 30 countries and territories that
are endemic for 6 or more. These diseases not only survive and spread in
conditions of poverty but also anchor large populations in poverty. (NTDs
designated by WHO for control or elimination: Buruli ulcer, Chagas disease
(American trypanosomiasis), cysticercosis/taeniasis, dengue / severe dengue,
dracunculiasis (Guinea worm disease), echinococcosis, fascioliasis, human
African trypanosomiasis, leishmaniasis, leprosy, lymphatic filariasis,
onchocerciasis, rabies, schistosomiasis, soil-transmitted helminthiasis,
trachoma, and yaws) 
About Lymphatic Filariasis 
Lymphatic filariasis is a parasitic disease that is transmitted to humans by
the bite of a mosquito. Once transmitted, it causes lymphatic dysfunction.
While infection is usually acquired during childhood, symptoms often gradually
appear over several years, with the most serious manifestations of the disease
occurring in adulthood. One of the most serious manifestations, known as
elephantiasis, is a permanent physical disability in which a patient's
lower extremities swell to resemble those of an elephant. In addition to
impacting a patient's ability to perform everyday tasks, it historically
has led to many patients falling victim to social persecution due to biases
against the disease. The disease also causes patients and their families much
emotional distress. Today, lymphatic filariasis affects an estimated 120
million people in 73 countries worldwide, most of whom live in developing and
emerging nations in Africa, Southeast Asia and other regions. In Japan, the
disease has been confirmed to have existed since the Heian period (794-1184),
but was successfully eliminated in the late 1970s as a result of initiatives
begun roughly ten years earlier by the Japanese government in partnership with
the public-private sector, with Japan then becoming the first country in the
world to demonstrate the successful achievement of lymphatic filariasis
About Eisai 
Eisai Co., Ltd. (TSE: 4523; ADR: ESALY) is a research-based human health care
(hhc) company that discovers, develops and markets products throughout the
world. Eisai focuses its efforts in three therapeutic areas: integrative
neuroscience, including neurology and psychiatric medicines; integrative
oncology, which encompasses oncotherapy and supportive-care treatments; and
vascular/immunological reaction. Through a global network of research
facilities, manufacturing sites and marketing subsidiaries, Eisai actively
participates in all aspects of the worldwide healthcare system. For more
information about Eisai Co., Ltd., please visit www.eisai.com. 
Public Relations Department,
Eisai Co., Ltd.
Copyright 2013 JCN Newswire. All rights reserved. www.japancorp.net 
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