Developing a Vaccine to Protect Against Pandemic Influenza Public Statement by GlaxoSmithKline 27 February 2007

2 Challenges for a Pandemic Vaccine The population is immunologically naïve to a pandemic virus Reactive production of a pandemic vaccine, even with a large capacity increase, could leave most people unprotected

3 GSK’s Position Advance production and stockpiling are the foundation of pandemic preparedness The ideal vaccine to support this approach: Effective against drift variants Antigen-sparing Can be stockpiled (shelf-life)

4 Effect of GSK’s Adjuvant System on Immune Response to H5N1 Vaccine Since baseline HI titers are largely <10, rates of ‘seroprotection” and seroconversion are essentially equal CHMP/CBER 70% criterion No Adjuvant With Adjuvant 3.8 ug7.5 ug15 ug30 ug % of Subjects (95% CI) No Adjuvant With Adjuvant No Adjuvant With Adjuvant No Adjuvant With Adjuvant ClinicalTrials.gov identifier: NCT

5 Regulations for Pre-Pandemic Vaccines Europe’s CHMP has issued comprehensive guidance Efficacy surrogate → HI antibody response to vaccine Supportive data for cross-protection: Cross-reactive neutralizing antibody responses Protection in ferret model Ability of vaccination to support a booster-response upon vaccination with a drifted strain GSK filed a EU license application for its pre-pandemic vaccine 29 Jan 07 GSK is discussing with FDA what evidence will enable a U.S. license application

6 GSK’s Pre-Pandemic Vaccine Development Plan Conduct pivotal trials of our vaccine with adjuvant under an IND in 2007 and file a U.S. license application While application under review, extend safety database, generate data for supplemental application: Pediatric indication General use prophylaxis of all ages