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liverpool.ac.uk); [EQ its.jnj.com Cc: Kajsa-Stina Longuere; Raul Pardinaz-Solis; Hayden, Frederick G *HS (Ho hscmail.mcc.virginia.edu); Gail Carson; Rebecca Howell-Jones @Ohotmail.com); Sigfrid Louise (EAST SUSSEX HEALTHCARE NHS TRUST) nhs.net) Subject: RE: Ebola Therapeutics WG Teleconference on Thursday September 18th at 15:00 BST _ Agenda and dial in numbers Importance: High Dear All, We look forward to speaking with you on Thursday at 15:00 BST. The agenda is: . Welcome- FGH ° New Introductions- All e WHO Update- MF, DW, VS, NS e Report from USCDC-WHO Clinical Teleconference- TU e Convalescent plasma/WB transfusion- DW, CS, TL e Animal model studies- LH, GO, , SB, GK e -- Brincidofovir (CMX001)- RL e Andeovirus-MVA vaccine strategy- BC (JNJ) e =Next steps The dial in numbers are attached. The PIN is: There are 4 attachments: the dial in numbers, a review on Selenium by Billy Fischer and two sets of minutes. If you have any queries please contact either Fred or me. Best wishes Gail Dr Gail Carson (formerly Thomson) ISARIC Clinical Coordinator From: Tatiana Verdon 5 September 2014 14:55 II; Michelle Berrey; Cc: Kajsa-Stina Longuere; Raul Pardinaz-Solis; Cail Carson; Hayden, Frederick G *HS @jjf@hscmail.mcc.virginia.edu) Subject: Ebola Therapeutics WG Teleconference on September 18th at 15:00 BST Dear All, Professor Fred Hayden would like to invite you to the next Ebola Therapeutics WG Teleconference on September 18" at 15:00 BST. The minutes from the last call and the dial in numbers will follow in due course. Best wishes, Tatiana ISARIC Coordination Centre, Oxford Favipiravir for Ebola October 16, 2014 Fujifilm Pharmaceuticals Fujifilm Holdings Toyama Chemical MediVector Mechanism of Action for Favipiravir Amantadine Influenza virus life cycle Adsorption CONH, Th, T-705 virus-cidal Vet. Incorporation -->- 1o0--__--_-- > Phosphoribosylation Phosphorylation Protein synth /\ Replication Assembly CONH, mos T-705RTP, Active form OH es= NA inhibitors . T-705 is converted to the ribosyl triphosphate and inhibits influenza virus RNA polymerase virus-static New Drug Application Approval favipiravir in Japan AVIGAN® Tablet 200mg ¢ March 24, 2014 ¢ Indications -- Novel or re-emerging influenza virus infections (limited to cases in which other anti-influenza virus agents are not effective or insufficiently effective) * Contraindications -- Women known or suspected to be pregnant ¢ Dosage and Administration (for adults in Japan) -- 1600 mg orally twice for 1 day followed by 600 mg orally twice daily for 4 days. The total administration period is five days. AVIGAN® is a drug the use of which is considered only when there is an outbreak of novel or re-emerging influenza virus infections in which other anti-influenza virus agents are not effective or insufficiently effective, and the government decides to use the drug as a countermeasure against such influenza viruses. It is manufactured upon request by the Minister of Health, Labor, and Welfare. = Availability, Manufacturing Capability ¢ Toyama currently has a stock of 2.8 million tablets in terms of the 200mg tablet. They correspond to 56,000 treatment courses under the dose regimen for the ongoing Phase 3 clinical studies for influenza (1,800mg BID on Day 1 followed by 800 mg BID on Day 2 to 5). Please note the dose regimen for Ebola treatment could be different than influenza. ¢ Upon request by the Minister of Health, Labor, and Welfare, our monthly manufacturing capacity is around 8 million tablets. In vitro antiviral activity of favipiravir against EBOV 2) Post-exposure efficacy of oral T-705 (Favipiravir) against inhalational Ebola virus infection in a mouse model. 1) Successful treatment of advanced Ebola virus infection with T-705 (favipiravir) in