GSK announces positive results of Seretide study in patients with chronic obstructive pulmonary disease (COPD)

GlaxoSmithKline plc announces preliminary results from the TORCH study (TOwards a Revolution in COPD Health) which show a 17% relative reduction in mortality over three years for patients receiving Seretide™ 50/500µg(EU) /Advair® (US) (salmeterol/fluticasone propionate) as compared with patients on placebo (p=0.052*). This is the first study to investigate the effects of pharmacotherapy on all-cause mortality in patients with COPD. The primary comparison was between Seretide / Advair and placebo.

Seretide / Advair also reduced the rate of COPD exacerbations by 25% compared to placebo (p<0.001) and resulted in an improvement in quality of life when compared to placebo as measured by the St George’s Respiratory Questionnaire (SGRQ) (p<0.001).

Adverse events seen in the study generally appear consistent with those seen in previous studies of Seretide / Advair in patients with COPD. Despite the reduced rate of exacerbations overall Seretide / Advair was associated with increased reporting of adverse events classified under lower respiratory tract infections, when compared with placebo (p<0.001).

GSK believes these data are clinically important and that they will have a positive impact on the future management of COPD. GSK will be working with regulatory authorities to incorporate these study findings into our prescribing information for Seretide / Advair (50/500µg).

A multi-centre, multinational, double-blind trial, TORCH enrolled over 6,100 patients with COPD into one of four treatment arms; Seretide / Advair (50/500µg), Serevent (salmeterol) (50µg), Flixotide / Flovent (fluticasone propionate) (500µg) or placebo over a treatment period of three years. The primary endpoint was all-cause mortality comparing Seretide / Advair with placebo and secondary endpoints were COPD exacerbations and quality of life. GSK will seek publication of the study in a peer-reviewed journal at the earliest opportunity.

Advair 50/500 is not licensed in the US for patients with COPD.

* A p value of less than or equal to 0.05, conventionally recognised as representing statistical significance, means there is a 5 in 100 possibility, or less, that the result was achieved through chance.

Notes to editors:

About TORCH
TORCH (TOwards a Revolution in COPD Health) 1 is the first and largest study to prospectively investigate the potential for Seretide/Advair) (salmeterol/fluticasone propionate) 50/500µg to impact survival in patients with chronic obstructive pulmonary disease (COPD). TORCH is a three year, multicentre, randomised, double-blind, parallel group placebo controlled study. Approximately 6,100 patients meeting the European Respiratory Society definitions for COPD were randomised from 439 sites in 42 countries to one of the following 4 treatment groups:

1. Placebo
2. Salmeterol (50µg)
3. Fluticasone propionate (500µg)
4. Seretide / Advair (50/500µg), all inhaled twice daily via the Diskus®/Accuhaler™.

The primary end point was the reduction in all-cause mortality, comparing salmeterol/fluticasone propionate with placebo. Improved survival is currently one of the greatest unmet needs in the management of COPD. Secondary endpoints include:

# COPD morbidity (as measured by the rate of exacerbations [moderate requiring systemic corticosteroids and/or antibiotics or severe requiring hospitalisation])

# Quality of life (as measure by St George’s Respiratory Questionnaire (SGRQ))

About COPD
Chronic Obstructive Pulmonary Disease (COPD) is a preventable and treatable disease state, characterised by airflow limitation that is not fully reversible. It is associated with an abnormal inflammatory response of the lungs to noxious particles or gases, especially cigarette smoke. COPD is an umbrella term that can be used to describe chronic bronchitis, emphysema, or a combination of these in patients with airflow obstruction.

COPD is a multi-component disease with airway inflammation at the core. Other components include airway structural changes, and mucociliary dysfunction. All lead to airflow limitation, together with an important systemic component. These contribute to a number of changes in lung function, symptoms and exacerbations, which affect health status and ultimately survival. 2-6

The World Health Organisation estimate that 600 million people worldwide have COPD.7 COPD is the only major leading cause of death that is increasing (coronary heart disease, stroke and other cardiovascular diseases all show constant and substantial reduction).

It is well documented that improving survival in COPD is currently one of the greatest unmet needs in treating COPD. To date smoking cessation in all COPD patients, and long term oxygen therapy for patients with low blood oxygen, have been the only non-surgical interventions shown to improve survival. 2 This is the first study that demonstrates a benefit of drug therapy on survival.

About Seretide / Advair
The brand name for fluticasone propionate/salmeterol in the European Union (excluding Germany) is Seretide . The brand name of fluticasone propionate/salmeterol in Germany is Viani™. The brand name for fluticasone propionate/salmeterol in US is Advair .

Seretide / Advair is a combined treatment of fluticasone propionate, an inhaled corticosteroid and salmeterol, a long acting bronchodilator. Each component targets different aspects of the pathophysiology of COPD a multi-component disease with inflammation at the core.

FOR EU Media
Seretide / Viani 50/500 is licensed in the European Union for the symptomatic treatment of patients with severe COPD (forced expiratory volume in one second FEV1 ? 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy.

FOR US Media
Advair 50/250 is licensed for twice-daily maintenance treatment of airflow obstruction in patients with COPD associated with bronchitis. Advair Diskus 50/500 is not approved for treatment of COPD in the US.

For International Media
Seretide / Advair 50/250 and 50/500 is approved for the treatment of COPD in over 40 countries in the international region including Australia, Canada, Mexico and Turkey.

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

References:

1. The TORCH study group. The TORCH (Towards a Revolution in COPD Health) survival study protocol. Eur Respir J 2004; 24: 206-210

2. Global Initiative for Chronic Lung Disease. Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease, updated 2005. NHLBI/WHO workshop and report. Bethesda, National Heart Lung and Blood Institute. GOLD website (www.goldcopd.com)

3. Agusti AGN. COPD, a multicomponent disease: implications for management. Respir Med 2005; 99: 670-682.

4. Agusti AGN, Noguera A, Sauleda J et al. Systemic effects of chronic pulmonary disease. Eur Respir J 2003; 21: 347-360.

5. Rodriguez-Roisin R. The airway pathophysiology of COPD: implications for treatment. COPD: Journal of Chronic Obstructive Pulmonary Disease 2005; 2: 253-262.

6. Buist AS, Vollmer WM. Smoking and other risk factors. In: Murray JF, Nadel JA (eds). Textbook of respiratory medicine. Philadelphia: WB Saunders, 1994: 1259-1287.

7. World Health Report 1998. Life in the 21st Century: A vision for all. World Health Organization, Geneva, 1998. pp46

Cautionary statement regarding forward-looking statements

Under the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statements or projections made by the company, 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 the Group’s operations are described under ’Risk Factors’ in the Operating and Financial Review and Prospects in the company’s Annual Report on Form 20-F for 2005.

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