NATIONAL INFLUENZA VACCINE SUMMIT
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
NATIONAL INFLUENZA VACCINE SUMMIT
E N D
Presentation Transcript
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