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

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.

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 Global launch ceremony at Vizag Plant

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 Eisai-DEC shipment to be completed by 2020 EPM Eisai-DEC shipment scheduled within 2014 Eisai-DEC shipment completed Eisai’s DEC tablets obtained prequalification from WHO in August 2013, the first NTD treatment to receive prequalification in the world 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 DEC tablet provision commenced at our Vizag plant in October 2013, tablets already shipped to 11 countries as of July 2014 　　 Shipments scheduled for two new countries (Indonesia, Madagascar) within 2014

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

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 DEC supply LF strip test hhc activity Discovery Development Manufacturing Delivery Awareness

Eisai ATM Navigator has Launched ! Accumulating knowledge of NTDs to support MDA and education http://atm.eisai.co.jp/english or Eisai atm

Eisai ATM Navigator FYI, to support training, MDA, etc… accessible by PC / Tablet / Smart phone Medical Information

Eisai ATM Navigator FYI, to support training, MDA, etc… DEC Package Insert Leaflet

Eisai ATM Navigator FYI, to support training, MDA, etc… DEC brochure

to patients and their families worldwide. 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.

どうもありがとうございます。 Thank you!

Appendix

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”.