Regulatory Approval

GlaxoSmithKline PLC 23 May 2003 Issued - London, United Kingdom 23 May 2003 GLAXOSMITHKLINE RECEIVES APPROVAL FROM THE EUROPEAN COMMISSION FOR SERETIDE(TM) DISKUS(TM) FOR THE TREATMENT OF COPD GlaxoSmithKline plc (LSE and NYSE: GSK) announced today that they have received an approval from the European Commission for the use of SeretideTM (Seretide Diskus 50/500, a combination of long-acting beta2-agonist, salmeterol and inhaled corticosteroid, fluticasone propionate) as a new treatment for patients with severe chronic obstructive pulmonary disease (COPD). Seretide is indicated for the symptomatic treatment of patients with severe COPD (FEV1<50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy. Each EU Member State will now review the decision and grant a local language version of the approval. "Today's approval of Seretide for COPD by the European Commission is not only a milestone for GSK, the world leader in respiratory medicine, but also for the millions of COPD patients in Europe. GSK is committed to fighting this debilitating disease and will continue to invest in research and development to improve the everyday lives of these sufferers", said Andrew Witty, President, Pharmaceuticals, Europe at GSK. COPD is a major health concern in Europe, where it is the fifth largest killer(1)and effects an estimated 340 million sufferers world-wide(2). COPD, a multi-component disease, remains highly undiagnosed and is the only leading cause of death in the world to be increasing in prevalence(3). 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. Seretide should be used with caution in patients with severe cardiovascular disorders. Some patients may experience an increase in heart rate or changes in heart rhythm. For additional information, please refer to the full prescribing information for Seretide. S M Bicknell Company Secretary 23 May 2003 -ENDS- Notes to Editors: Salmeterol / fluticasone propionate combination is marketed as SeretideTM DiskusTM in most European countries and as SeretideTM AccuhalerTM in the United Kingdom and is indicated for the treatment of asthma in adults and children (over the age of four years for the Accuhaler in the United Kingdom) for whom treatment with both inhaled corticosteroid and a long-acting beta2-agonist is appropriate. The licence varies depending on the country and it is recommended that journalists seek advice from the relevant GlaxoSmithKline local operating company. Enquiries: UK Media enquiries: Martin Sutton (020) 8047 5502 David Mawdsley (020) 8047 5502 US Media enquiries: Nancy Pekarek (215) 751 7709 Mary Anne Rhyne (919) 483 2839 Patricia Seif (215) 751 7709 European Analyst/Investor enquiries: Duncan Learmouth (020) 8047 5540 Anita Kidgell (020) 8047 5542 Philip Thomson (020) 8047 5543 US Analyst/ Investor enquiries: Frank Murdolo (215) 751 7002 Tom Curry (215) 751 5419 References: 1.Murray CJL, Lopez AD. Eds. The Global Burden of Disease: a comprehensive assessment of mortality and disability from diseases, injuries, and risk factors in 1990 and projected to 2002. Cambridge; Harvard University Press; 1996. 2. The World Health Report 1998. Life in the 21st Century. A vision for all. World Health Organisation, Geneva, 1998. 3. NHLBI/WHO Workshop Report. Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the diagnosis, management and prevention of chronic obstructive pulmonary disease, 2001. This information is provided by RNS The company news service from the London Stock Exchange

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