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CSL 2009 Influenza A (H1N1) Vaccine Development Plans. FDA, CBER, VRBPAC Meeting July 23, 2009 Jillian Bennet, CSL Ltd . Overview of presentation. CSL Biotherapies US licensed seasonal vaccine Afluria ® Plans for novel H1N1 manufacture and supply Clinical trial program Design Status.

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Csl 2009 influenza a h1n1 vaccine development plans

CSL 2009 Influenza A (H1N1) VaccineDevelopment Plans

FDA, CBER, VRBPAC Meeting

July 23, 2009

Jillian Bennet, CSL Ltd

Proprietary For Official Use Only


Overview of presentation
Overview of presentation

  • CSL Biotherapies US licensed seasonal vaccine

    • Afluria®

  • Plans for novel H1N1 manufacture and supply

  • Clinical trial program

    • Design

    • Status

Proprietary For Official Use Only


Csl biotherapies influenza vaccine afluria
CSL Biotherapies Influenza Vaccine (Afluria®)

  • US indications

  • CSL experience - 70 millions doses distributed

  • Licensed in 27 countries

Proprietary For Official Use Only


Afluria manufacturing overview
Afluria® Manufacturing Overview

Split virion, inactivated vaccine

  • Presentations licensed

    • Thimerosal-free PFS

    • Multidose vial

  • Manufacture

    • Antigen manufacture Australia for NH & SH

    • Fill & finish

      • Australia

      • Germany

      • USA (pending FDA approval)

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Afluria h1n1 2009 current status
Afluria® &H1N1 2009 Current Status

  • Seasonal TIV Status

    • On track to meet US forecast commitments

  • A/California/7/2009 (H1N1)

    • Strain X-179A

    • Manufacture commenced June 09

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Csl influenza vaccine planning calendar 2009
CSL Influenza Vaccine Planning Calendar 2009

Jan

Feb

Mar

Apr

May

Jun

Jul

Aug

Sep

Oct

Nov

Dec

Antigen

Northern Hemisphere

H1N1

SH

Production

Vaccine

Formulation

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Csl 2009 influenza a h1n1 clinical trials
CSL 2009 Influenza A (H1N1) Clinical Trials

Two clinical programs

  • Australia & US - complementary, overlapping

  • US Program

    • Execute under BARDA, HHS Contract

    • IND filed with FDA

  • Thimerosal-free formulation for pediatric trials

Proprietary For Official Use Only


Csl 2009 influenza a h1n1 vaccine clinical trials
CSL 2009 Influenza A (H1N1) Vaccine Clinical Trials

Proprietary For Official Use Only


Csl 2009 influenza a h1n1 vaccine us trials
CSL 2009 Influenza A (H1N1) Vaccine US Trials

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Csl 2009 influenza a h1n1 vaccine trial endpoints
CSL 2009 Influenza A (H1N1) Vaccine Trial Endpoints

  • Immunogenicity

    • HI response post-dose 1 & 2

    • Seroconversion

    • Seroprotection rate > 1:40

  • Safety

    • 21 days post-dose 1 & 2

    • Monthly assessments to 6 months

      • Facilitate timely safety signal detection

      • (SAEs, AESI, deaths, new onset chronic illness)

  • Interim review of immunogenicity and safety data after dose 1 & 2

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Summary csl 2009 influenza a h1n1 vaccine
Summary - CSL 2009 Influenza A (H1N1) Vaccine

  • CSL Biotherapies has commenced manufacture of antigen

  • Clinical trials have commenced in Australia

    • Initial data will be shared with FDA in September

  • IND filed with FDA

    • US clinical trials will commence in mid-August

  • Vaccine will be thimerosal-free in pediatric trials

  • Vaccine will be supplied to NIAID for additional trials

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