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Release is embargoed until 11.18am (CET), 2 September 2007

Major ADVANCE for type 2 diabetics

Blood Pressure lowering drug Coversyl Plus saves lives in type 2 diabetics

VIENNA, Austria, 2 September 2007 – The routine administration of a fixed combination of perindopril and indapamide (Coversyl Plus) improves survival and reduces coronary and renal events in diabetics, according to the results of the blood pressure–lowering arm of the landmark, five year ADVANCE^1,2 (Action in Diabetes and Vascular Disease: perindopril/indapamide and Diamicron MR Controlled Evaluation), study presented today³ at the European Society of Cardiology (ESC) meeting and published online in The Lancet.

ADVANCE is the first and largest trial ever performed with a fixed combination antihypertensive in type 2 diabetic patients. The multicentre, randomised, placebo controlled study involved a total of 11,140 patients with type 2 diabetes from 20 countries worldwide, including 442 Irish patients from 5 different centres. Patients included were both normotensive and hypertensive and were already receiving most of the usual treatments provided to patients with diabetes, including other blood pressure lowering drugs.

ADVANCE showed that Coversyl Plus significantly reduces total mortality by 14% and the risk of cardiovascular death by 18%. In absolute terms, one death would be avoided for every 79 patients treated with Coversyl Plus for five years. In addition, patients receiving Coversyl Plus achieved a significant 14% reduction in total coronary events and a 21% reduction in renal events. That means that one coronary event would be avoided for every 75 patients treated with Coversyl Plus for five years and one renal event would be avoided for every 20 patients treated with Coversyl Plus for five years.

“The results of ADVANCE should have major implications for guidelines, clinical care and public policies”, says co-principal study organizer Professor Stephen MacMahon from The George Institute for International Health, Sydney Australia, and he adds "These results represent an important step forward in health care for the millions of people with diabetes worldwide. This treatment reduced the likelihood of dying from the complications of diabetes by almost one-fifth, with virtually no side-effects.”

Alice Stanton, from the ASCOT Clinic in Beaumont Hospital in Dublin is one of the five Irish investigators involved in the ADVANCE trial. Dr Stanton traveled to attend the ESC meeting in Vienna to hear the results today. She commented ““In ADVANCE, the largest prevention study conducted in Type 2 diabetes, protection from both major macro and microvascular events were seen through the use of perindopril and indapamide. The benefits of combined perindopril and indapamide therapy were additional to all standard currently recommended therapies for Type 2 Diabetes, including hypoglycaemics, statins, ACE inhibitors and aspirin. This study prompts the question of whether the prescription of perindopril and indapamide should be considered in all type 2 diabtets, irrespective of Blood Pressure levels.”

Dr John Barton, Consultant Cardiologist, Portuincula Hospital, Ballinasloe, Co Galway, another Irish investigator, and also in attendance at the unveiling of the ADVANCE results in Vienna commented “Evidence of the ADVANCE trial is showing that an addition of perindopril and indapamide to standard blood pressure treatment has a significant beneficial effect on mortality I’m impressed by the reduction in overall mortality by the reduction in cardiovascular deaths, coronary events and renal events (including frank nethrophy and microalbuminuria).”

Coversyl Plus was chosen for the ADVANCE trial for its efficacy in treating the alterations in both large arteries and the microcirculation which commonly occur in hypertensives and diabetics. Moreover, Coversyl Plus achieves a strong blood pressure lowering efficacy, specific benefits on cardiac perfusion and protection of the heart and kidney.

Diabetes mellitus is emerging as one of the greatest threats to the health of populations worldwide; estimated to affect 366 million by 2030. It is associated with increased risks of microvascular complications (retinopathy, nephropathy and neuropathy) and macrovascular disease (coronary heart disease, stroke and peripheral vascular disease). In Ireland, it is estimated that around 200,000 (4.7%) people have diabetes⁴. 90% are thought to have type 2 diabetes and diabetes is more common in women (5.4%) than men (4%). The prevalence of diabetes increases with age.

Commenting on the results, Kieran O’Leary, Manager of the Diabetes Federation of Ireland said, "Type 2 Diabetes is a serious illness effecting over 200,000 people in Ireland with possibly the same number unaware that they have the illness. The Diabetes Federation of Ireland welcomes the results of the ADVANCE Trial and are encouraged to see so many Irish patients took part in the trial. We hope that this trial will encourage people to get tested for Type 2 Diabetes and those at high risk or diagnosed get actively involved in managing their own condition through dietary modifications and regular physical activity in order to prevent/delay the onset of type 2 diabetes and control the associated conditions."

“Diabetes is emerging as one of the greatest 21st century threats to the health of populations worldwide. The health gains seen in the ADVANCE study have been obtained in addition to the benefits provided by patients’ existing treatment and if the benefits seen in ADVANCE were applied to just half the population with diabetes worldwide, more than a million deaths would be avoided over 5 years… there is now a case for considering routine treatment with Coversyl Plus for patients with type 2 diabetes”, comments Professor John Chalmers, ADVANCE co-principal Investigator also from the George Institute for International Health. The ADVANCE study was initiated and designed by the investigators and co-sponsored by The George Institute for International Health and the University of Sydney, and Servier. A second arm of the study, that sets out to assess the risks and benefits of intensive glucose lowering using a gliclazide MR-based regimen (Diamicron MR) will report later.

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For further information, please contact:

Jill O’Herlihy OHC 01 660 2744 / 087 795 7717

About Servier Foundation

SERVIER is the leading independent French pharmaceutical company and the second French pharmaceutical company worldwide. SERVIER is established in 140 countries, with 82% of SERVIER's sales achieved internationally. Consolidated turnover for the 2006 financial year: €3.3 billion, with a growth of 16.6%. Research and Development investment is close to 25% of SERVIER's turnover (mean for the past 5 years). Worldwide, SERVIER has a workforce of almost 20,000, including 2,600 in Research and Development. The SERVIER Clinical Support Unit in Gidy (France) is the largest unit in Europe producing drugs for clinical trials. All told, 670 million boxes of drugs were produced by SERVIER's production sites in 2006.

In October 2006, Minister Micheal Martin announced the € 184 million expansion by Servier in Ireland, which will lead to the creation of 267 jobs in Kilkenny and Wicklow. Servier plans to build a new € 115 million facility at Belview in South Kilkenny. This factory will employ up to 155 people within about seven years. The remaining new jobs will be located at the company’s plant in Arklow, Co. Wicklow, which is going to be expanded under a € 69 million development plan (currently employing 206 in manufacturing). Servier Laboratories Ireland Ltd, based in Dun Laoghaire Co. Dublin, is also employing 60 people committed to providing medical information and programmes of continuous medical education.

In February 2007, Mary Harney, T.D., Minister for Health & Children announced at a press conference a unique partnership with leading French pharmaceutical company Servier Laboratories in the UCD Conway Institute, which will make a significant investment over 5 years in a collaborative venture that will enable the establishment of the ‘UCD Servier Centre for Translational Medicine, a Franco-Irish Collaboration Bringing Science to Society’, and marks the beginning of a five-year commitment to the development of a Centre for Excellence in Biopharmaceutical Sciences.

Coversyl Plus and Diamicron MR are manufacturered in Arklow, Co. Wicklow.

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For further information, please contact:

Jill O’Herlihy OHC 01 660 2744/ 087 795 7717

Servier Laboratories (Ireland) Ltd, Block 2, West Pier Business Campus, Old Dunleary Road, Dun Laoghaire, Co Dublin. www.servier.com

Email: information@ie.netgrs.com, telephone: +353 (0)1 66 38 110

Further information is available at www.advance-trial.com or www.servier.ie

References:

1. ADVANCE Collaborative Group, Blood Pressure 2006;15:340-346

2. ADVANCE Collaborative Group, J.Hypertens. 2001,19(suppl 4):S21-S28

3. Data presented at a hotline session of the European Society of Cardiology meeting 2 September 2007

4. Making Diabetes Count, The Institute of Public Health in Ireland. 2006

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________________________________

Jill O’Herlihy-Ryan
Account Director

OHC - O'Herlihy Communications
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Dublin 4, Ireland

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