Transcript Eisai update Sep2014_0926

Current Status of Eisai DEC Provision
(Lymphatic Filariasis Elimination Partnership)
September 26th, 2014
Takayuki Hida, Ph.D
Global Access Strategies
Eisai Co., Ltd.
Topics
 DEC production and supply update
 Eisai's continuous contribution to LF elimination
 Eisai ATM Navigator
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Confidential. For internal use only. Do not copy or distribute.
DEC supply - Background
 Eisai signed a statement of intent with WHO to supply free of charge
DEC for the elimination of lymphatic filariasis in Nov. 2010, this is the
first partnership between WHO and the Japanese pharmaceutical
company.
 Eisai agreed to produce and supply up to 2.2 billion of 100 mg DEC
tablets in accordance with the high quality standard of WHO by 2020.
 Eisai decided to develop the DEC tablets from scratch with our cuttingedge factory in Visakhapatnam “Vizag” - India, and also decided to
utilize Pre-Qualification system by WHO for official supply.
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Start of Eisai DEC Supply to WHO in Oct. 2013
DEC production at Eisai’s Vizag Plant began on August 28, 2013
- Each tablet is printed with “E” logo and bottle label contains message about
Eisai’s price-zero supply of DEC to WHO
First shipment from Vizag was achieved for Papua New Guinea, Kiribati, Tuvalu
and Fiji on Oct. 28th, 2013
Eisai’s message:
“Provided by Eisai to
WHO for distribution
free of charge in
designated lymphatic
filariasis control
programmes.”
Eisai-produced DEC tablet and bottle
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Global launch ceremony at Vizag Plant
Confidential. For internal use only. Do not copy or distribute.
Commitment to WHO’s Global Programme to Eliminate Lymphatic Filariasis
New Eisai Products Supplied at Price Zero


Eisai’s DEC tablets obtained prequalification from WHO in August 2013
2.2 billion tablets to be provided free of charge to WHO for 250 million at-risk patients in 26
LF endemic countries worldwide by 2020
E
EPM
Eisai-DEC shipment completed
E
Eisai-DEC shipment scheduled within 2014
Eisai-DEC shipment to be completed by 2020
E
Confidential. For internal use only. Do not copy or distribute.
Achievements & Next
 Eisai’s DEC tablets obtained prequalification from WHO in August
2013, the first NTD treatment to receive prequalification in the world
 DEC tablet provision commenced at our Vizag plant in October
2013, tablets already shipped to 11 countries and WHO Geneva as
of July 2014
 Shipments are scheduled for five new countries (Indonesia,
Madagascar, Eritrea, LaoPDR and Malaysia) within 2014
 Eisai can deliver up to 400 million tablets per year
Shipment result as of July 2014 (Million Tablets)
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Shipment #
1
2
3
4
5
6
7
8
9
10
11
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First shipment
Oct.2013
Oct.2013
Oct.2013
Oct.2013
Feb.2014
Feb.2014
Feb.2014
Mar.2014
Mar.2014
Mar.2014
Apr.2014
Jul.2014
Total
Total tablets
0.02
1.46
0.03
0.03
0.2
0.04
1.33
0.16
80
0.5
25
8.5
116.8
Guyana
Samoa
Myanmar
Dominican
Republic
Zambia
Kenya
Jun.2014
Apr.2014
Aug.2014
Sep.2014
Aug.2014
Aug.2014
Destination
Kiribati
PNG
Fiji
Tuvalu
Micronesia
WHO
Geneva
First MDA
Apr.2014
Apr.2014
Aug.2014
Aug. 2014
Apr. 2014
Buffer stock
Confidential. For internal use only. Do not copy or distribute.
Our continuous contribution to LF elimination
 Discovery and Development

Novel research of anti-Wolbachia targeted anti-filarial drug with
Liverpool School of Tropical Medicine (started in Feb. 2014)
 Manufacture and Delivery – drug

Eisai DEC supply for free/Price Zero (on-going)
 Delivery – diagnostic kit for TAS

LF test strip consortium (Alere with BMGF, Eisai, GSK, Merck and WHO)
(comparative studies in progress)
 Awareness

Awareness campaign at endemic area in Asian countries “hhc“ activities with Eisai employees (on-going)
anti-wolbachia drug
Discovery
DEC supply
Development
Manufacturing
LF strip test
hhc activity
Delivery
Awareness
Confidential. For internal use only. Do not copy or distribute.
Eisai ATM Navigator has Launched !
 Accumulating knowledge of NTDs to support MDA and education
http://atm.eisai.co.jp/english or
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Eisai atm
Confidential. For internal use only. Do not copy or distribute.
Eisai ATM Navigator
 FYI, to support training, MDA, etc…
accessible by PC / Tablet / Smart phone
 Medical Information
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Confidential. For internal use only. Do not copy or distribute.
Eisai ATM Navigator
 FYI, to support training, MDA, etc…
 DEC Package Insert Leaflet
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Confidential. For internal use only. Do not copy or distribute.
Eisai ATM Navigator
 FYI, to support training, MDA, etc…
 DEC brochure
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Confidential. For internal use only. Do not copy or distribute.
Wrap up
 Eisai successfully launched and initiated supply of DEC
in October 2013, with three years endeavors.
 As of July 2014, Eisai shipped total 117 million of DEC
tablets for 11 countries.
 Eisai will support funding to supply LF strip test for
diagnosis as a part of LF elimination consortium.
 Eisai also provides information related to LF and NTDs.
Eisai is committed to the provision of DEC as to increasing
the benefits that health care provides
to patients and their families worldwide.
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どうもありがとうござい
ます。
Thank you!
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Appendix
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Eisai DEC was successfully Prequalified by WHO!
 DEC (diethylcarbamazine citrate) 100 mg tablets from Eisai’s Vizag Plant, India
prequalified by WHO on August 20th, 2013
 First case worldwide of pharmaceutical company receiving WHO prequalification
for NTD (neglected tropical disease) drug
 Prequalification received in less than 10 months from submission of application
(news release from WHO commends Eisai’s response during application
process as “setting an example for all manufacturers seeking prequalification”)
 WHO news release mentioned that “Our counterparts
at Eisai set an example for all manufacturers seeking
prequalification. Their readiness to respond to WHO
requests for further information and data concerning
their product, and their willingness to open the
manufacturing site of the finished product for
inspection, were exemplary”.
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Confidential. For internal use only. Do not copy or distribute.