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NATIONAL INFLUENZA VACCINE SUMMIT Atlanta – January 24-25, 2006 GSK is Committed to Influenza Prevention 2005 Highlights Launched expansion of the Dresden Plant to double production capacity by 2008 Acquired ID Biomedical Corporation Fluviral TM BLA pending submission
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NATIONAL INFLUENZA VACCINE SUMMIT Atlanta – January 24-25, 2006
GSK is Committed to Influenza Prevention2005 Highlights • Launched expansion of the Dresden Plant • to double production capacity by 2008 • Acquired ID Biomedical Corporation • FluviralTMBLA pending submission • Acquired US manufacturing facility (Marietta, PA) • cell culture-based vaccines (pandemic/inter-pandemic) • Announced development of improved influenza vaccine • novel adjuvant
Fluarix™ Distribution Update2005/6 Season • BLA approved August 31 • 7.5 million doses distributed • All doses distributed by October • Distribution primarily through supply houses serving high priority immunizers (hospitals, LTC) 2005 Fluarix™ Deliveries to US distributors
Guidance for 2006/7 Season GSK’s goal is to distribute 20 to 30 million doses pending 2006 expansion and FDA licensure of Fluviral 1. FluarixTM - 7 to 9 million doses • prefilled syringes • Residual thimerosal (<1.25 mcg per dose) as a result of manufacturing process • licensed for >=18 years of age 2. FluviralTM -Goal- licensure in time for 2006/7 flu season and supply 15 to 20 million doses • 10-dose vials • Thimerosal as a preservative ( 0.01% per dose) • granted fast track status by FDA and is eligible for priority review • GSK working with FDA to seek licensure for >=18 years of age • Working with FDA on pediatric indication
GSK 2006/2007 Distribution Plans Distribution Objective – Offer Flu vaccine to a wide breadth of customers • Fluarix and Fluviral (25-30MM doses) • Public Health Depts • Office Based physicians • Long term care • Hospitals • Mass Immunizers
GSK guiding principles for influenza vaccine • GSK will be a leader in influenza vaccine and respond to global public health needs • GSK will continue innovation to improve vaccine effectiveness and production processes • GSK is committed to sharing information with public health • GSK is committed to looking at avenues for improving the influenza vaccine system • GSK has made significant investment and is committed, long term, to the influenza market