GlaxoSmithKline commences Phase III study of intravenous zanamivir for hospitalised patients with influenza

Issued: London UK

GlaxoSmithKline (GSK) announced today that the first patient has received treatment in a pivotal Phase III study of hospitalised patients with influenza which compares intravenous (IV) zanamivir to oral oseltamivir. The primary endpoint of this study is time to clinical response in patients with confirmed influenza.

The trial has a target enrolment of 462 patients planned in over 20 countries that take into account flu seasons in the northern and southern hemispheres. The study will take approximately three years.

Notes to editors

IV zanamivir is not approved for sale in any country. Zanamivir has been available in countries worldwide in an inhaled form since 1999 and is licensed exclusively and globally from Biota.

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com

Cautionary statement regarding forward-looking statements Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2009.