GSK announcement on worldwide trial into cardiovascular disease

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GSK announcement on worldwide trial into cardiovascular disease

London, September 1, 2003 - GlaxoSmithKline today announce co-sponsorship* of one of the world’s largest ever drug trials into cardiovascular disease, the leading cause of death in the developed world. Comprising over 29,000 patients across 700 locations worldwide, The ONTARGETTM Trial Programme will look at whether Pritor ® (telmisartan) is able to protect people at high risk from suffering CV problems such as strokes, heart attacks and heart failure. Pritor ® was chosen because of its excellent tolerability, potency and reliable 24-hour duration of action.

Interest in the trial programme has been considerable, reflected by the speed with which patients have been recruited to it. The ONTARGETTM trial completed recruitment in May this year — 7 months earlier that scheduled.

Commenting on the study, Professor Peter Sleight, European Co-ordinator for The ONTARGET™ Trial Programme, and Professor Emeritus of Cardiovascular Medicine in the University of Oxford at the John Radcliffe Hospital, UK said, "The exceptionally rapid recruitment for this trial is a clear indicator of the widespread academic and clinical interest in the potential of telmisartan in cardiovascular protection, and the comparisons with ramipril alone, or the combination of ramipril and telmisartan. The ONTARGET™ trial will increase our understanding of how to lower cardiovascular risk, and as such, this trial represents a major milestone in the study of cardiovascular protection."

Lawson Macartney, Vice President, Global Therapy Area Strategy for Cardiovascular, Metabolic and Urology at GSK said, " Despite effective therapies to manage individual risk factors in cardiovascular disease, this remains the leading cause of death in the developed world. The ONTARGET trial programme will be one of the most comprehensive programmes of clinical research into protection against cardiovascular disease to date. The knowledge gained from this research has the potential to revolutionise cardiovascular care for the many millions worldwide at risk of these increasingly prevalent diseases and GSK is delighted to be a co-sponsor of this landmark clinical study."

Pritor ® is in a class of medicines known as angiotensin II receptor blockers (ARBs) that are routinely used in lowering high blood pressure (hypertension). It is as effective in reducing blood pressure (BP) as other classes of antihypertensive medicine (e.g. ACE inhibitors, beta-blockers and calcium channel blockers) without causing the side effects associated with these other classes of drug. Pritor ® is effective during the critical 18-24 hour post-dose period, during which time patients are most at risk from a cardiovascular event such as myocardial infarction, sudden cardiac death and stroke1.

Co-sponsorship of The ONTARGETTM Trial Programme reflects a growing commitment by GSK to the study of cardiovascular medicines, and the development of innovative treatments for patients at risk of cardiovascular disease (CVD). GSK has a diverse portfolio of medicines targeted at reducing the multiple risk factors associated with CVD. This includes Avandia ®, Lacipil ®, Pritor ®, NiQuitin ® and Zyban ® as well as a number of compounds in development.

To further support innovation in CV medicine, GSK has set up a Research and Education Foundation for Cardiovascular Disease (http://www.cvfoundation.org), a professional organisation comprised of leading researchers dedicated to fostering cutting-edge cardiovascular research and inspiring leadership in new scientists.

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.

* Boehringer Ingelheim is the main sponsor of The ONTARGET™ Trial Programme and markets telmisartan as Micardis ®.

Notes for Editors

ONTARGET/TRANSCENDTM

Rationale: To build on the results of the HOPE (Heart Outcomes Prevention Evaluation) study. The ONTARGETTM Trial Programme will establish whether more complete blockade of the renin-angiotensin system (with the use of an ARB alone, or in combination with an ACEi) has an additional protective effect in patients at high risk of cardiovascular disease. It will also establish, via the TRANSCENDTM arm, whether cardiovascular outcomes can be improved in patients intolerant, mostly of the side effects, of ACEi2,3.

Inclusion criteria: Patients at high risk of cardiovascular disease, similar to those studied in HOPE. >55 years, history of coronary artery disease (CAD), stroke or transient ischaemic attacks (TIA), peripheral arterial occlusive disease (PAOD), type 1 diabetes or type 2 diabetes with end-organ damage (retinopathy, left ventricular hypertrophy, macro/microalbuminuria, or any evidence of cardiac or vascular disease. A total of 28,317 patients have now been enrolled.

Endpoints: As well as the primary endpoints of stroke, myocardial infarction, cardiovascular mortality and hospitalisation for congestive heart failure (CHF), a number of secondary endpoints will be examined in ONTARGETTM, including newly diagnosed CHF, revascularisation procedures, newly diagnosed diabetes, cognitive decline/dementia, new onset of atrial fibrillation and nephropathy. ONTARGETTM therefore represents the most ambitious ARB cardiovascular protection trial to date.

Results: Results of The ONTARGETTM Trial Programme are expected to be available in 2007. Baseline data are expected to be presented in 2004.

Pritor ® (telmisartan):
GSK currently promotes Pritor ® in a wide number of European and international countries under a co-marketing agreement with Boehringer Ingelheim. To-date, over 20 million prescriptions4 for telmisartan have been written worldwide.

Pritor ® shares the excellent safety profile of other ARBs, and is well tolerated and effective when used in combination with other antihypertensives or other commonly used medicines.

Further studies in Pritor ®
Pritor is the subject of an extensive programme of clinical research, which includes PROTECTION (Programme of Research tO show Telmisartan End-organ proteCTION) and PRoFESS (Prevention Regimen For Effectively avoiding Second Strokes).

References: Muller J et al. N Engl J Med 1985; 313: 1315-22 Yusuf S et al. AM J Cardiol 2002 Unger T. Am J Cardiol 2002 International Medical Statistics

GSK Enquiries UK Media Martin Sutton
David Mawdsley
Chris Hunter-Ward 020 8047 5502
020 8047 5502
020 8047 5502 US Media Nancy Pekarek
Mary Anne Rhyne
Patricia Seif (215) 751 7709
(919) 483 2839
(215) 751 7709 European Analyst/Investor Duncan Learmouth
Philip Thomson
Anita Kidgell 020 8047 5540
020 8047 5543
020 8047 5542 US Analyst/Investor Frank Murdolo
Tom Curry (215) 751 7002
(215) 751 5419

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