Seretide COPD Study Results

GlaxoSmithKline PLC
28 March 2006



Issued - 28 March 2006, London, UK



   GSK ANNOUNCES POSITIVE RESULTS OF SERETIDE SURVIVAL 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 SeretideTM 50/500(micro)g (EU) /Advair
(R) (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 (50/500(micro)g).



A multi-centre, multinational, double-blind trial, TORCH enrolled over 6,100
patients with COPD into one of four treatment arms; Seretide/Advair (50/500
(micro)g), Serevent (salmeterol) (50(micro)g), Flixotide/Flovent (fluticasone
propionate) (500(micro)g) 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.



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



S M Bicknell

Company Secretary

28 March 2006



* 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 SeretideTM /Advair(R)) (salmeterol/
fluticasone propionate) 50/500(micro)g 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 (50(micro)g)

3)       Fluticasone propionate (500(micro)g)

4)       Seretide/Advair (50/500(micro)g), all inhaled twice daily via the
Diskus(R)/AccuhalerTM.



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 VianiTM. 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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