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September 26th, 2014
Takayuki Hida, Ph.DGlobal Access Strategies
Eisai Co., Ltd.
Current Status of Eisai DEC Provision(Lymphatic Filariasis Elimination Partnership)
Confidential. For internal use only. Do not copy or distribute. 2
Topics
DEC production and supply update
Eisai's continuous contribution to LF elimination
Eisai ATM Navigator
Confidential. For internal use only. Do not copy or distribute. 3
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 cutting-edge factory in Visakhapatnam “Vizag” - India, and also decided to utilize Pre-Qualification system by WHO for official supply.
Confidential. For internal use only. Do not copy or distribute.
Start of Eisai DEC Supply to WHO in Oct. 2013
Eisai-produced DEC tablet and bottle
Eisai’s message:“Provided by Eisai to WHO for distribution
free of charge in designated lymphatic
filariasis control programmes.”
4
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
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
E
E
Eisai-DEC shipment to be completed by 2020
EPM
E
Eisai-DEC shipment scheduled within 2014
Eisai-DEC shipment completed
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
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
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
6
Shipment result as of July 2014 (Million Tablets)Shipment # 1 2 3 4 5 6 7 8 9 10 11 12
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
Destination Kiribati PNG Fiji Tuvalu MicronesiaWHO
GenevaGuyana Samoa Myanmar
DominicanRepublic
Zambia Kenya
First MDA Apr.2014 Apr.2014 Aug.2014 Aug. 2014 Apr. 2014 Buffer stock Jun.2014 Apr.2014 Aug.2014 Sep.2014 Aug.2014 Aug.2014
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)
Discovery Development Delivery AwarenessManufacturing
anti-wolbachia druganti-wolbachia drug DEC supplyDEC supply LF strip testLF strip test hhc activityhhc activity
Confidential. For internal use only. Do not copy or distribute.
Accumulating knowledge of NTDs to support MDA and education
http://atm.eisai.co.jp/english or
Eisai ATM Navigator has Launched !
8
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
9
Confidential. For internal use only. Do not copy or distribute.
Eisai ATM Navigator FYI, to support training, MDA, etc…
DEC Package Insert Leaflet
10
Confidential. For internal use only. Do not copy or distribute.
Eisai ATM Navigator FYI, to support training, MDA, etc…
DEC brochure
11
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.
12
Confidential. For internal use only. Do not copy or distribute. 15
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”.