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MEDICAL NEWS RELEASE

Protelos, first in new class of osteoporosis therapies launched today

LONDON, 22nd November 2004 - Protelos (strontium ranelate), the only osteoporosis therapy to simultaneously increase bone formation and decrease bone resorption, was launched today by Servier Laboratories. The first in a new class of osteoporosis therapies called dual action bone agents (DABAs), Protelos is licenced for the treatment of postmenopausal osteoporosis to reduce the risk of vertebral and hip fracture.

Osteoporosis is the most common human metabolic bone disorder. At least one in three adult women and one in twelve adult men over 50 will sustain one or more vertebral, hip or other fractures and the combined social care and medical costs for treating osteoporotic fractures is estimated to be at least £1.7 billion annually in the UK.3 Up to half of hip fracture patients lose the ability to live independently,4 and up to 20% may die during the subsequent year as a result of the fracture.5

Commenting on the launch, Protelos UK study co-ordinator Prof Tim Spector of St Thomas’ Hospital, London said, ‘Protelos represents a real advance in the treatment of osteoporosis. Not only does it have a new and unique dual action on bone loss and formation, it also has proven fracture risk reduction, a straightforward dosing regimen and is well tolerated. This should improve long-term compliance and give maximum benefit to patients.’

The aim of patient management is to prevent initial osteoporotic fractures from occurring in those at high risk and prevent recurrence of fracture in patients who have already experienced them.

The results from the SOTI (Spinal Osteoporosis Therapeutic Intervention) study conducted in 1,649 post menopausal women and published in the New England Journal of Medicine earlier this year, showed that Protelos reduced the risk of vertebral fracture by 49% after 1 year and by 41% after 3 years of treatment.6 In addition to the reduction in fracture risk, Strontium ranelate also increased bone mineral density over three years by 12.7% at the lumbar spine, 7.2% at the femoral neck and 8.6% at total hip (all P<0.001).6

Protelos is the first non-bisphosphonate licenced to reduce hip fracture. In the TROPOS (Treatment of Peripheral Osteoporosis) trial, a 36% reduction in hip fractures over three years was shown in women aged 74 and above.7 In an elderly, high risk population (over 80), Protelos has also been shown to reduce the risk of vertebral fracture by 32% and non vertebral fracture by 31% compared to placebo, over 3 years in patients.8 Few, if any, drugs have proven anti-fracture efficacy in this high-risk group.

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Speaking at the launch, Jackie Parrington, Membership & Stakeholder Services Manager

National Osteoporosis Society (NOS) said, ‘The NOS welcomes the launch of Protelos as it extends the number of treatment options open to both doctors and patients alike. Osteoporosis is often overlooked as part of getting old and I hope today’s launch raises awareness of the severity of the condition and alerts us all to taking greater care of our bones.’

In all trials Protelos was well tolerated and, unlike bisphosphonates, it causes very few upper gastrointestinal problems and can be taken on an empty stomach with no requirement for the patient to remain upright.6,7 Protelos is a tasteless powder provided in 2 g sachets to be mixed in a glass of water. The recommended daily dose is 2 g/day. Protelos should preferably be taken at bedtime at least two hours after eating.

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For further information, please contact:

Rachel HindLaura Anderson

Athena Medical PRAthena Medical PR

Tel: 020 8956 2296Tel: 020 8956 2861

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NOTES TO EDITORS

  • Protelos has only been studied for use in postmenopausal women to date.
  • Protelos costs £25.60 for a months supply (28 sachets).
  • Servier Laboratories is an independently owned pharmaceutical company based in France. Servier has over 16,000 employees worldwide including 2,500 in research and development.
  • Servier’s commitment to research has resulted in one of the most active product pipelines in the industry. The Company invests over 25% of annual turnover into research, a figure double the industry average.
  • In 2002, Servier was awarded the Prix Galien for the ‘quality, quantity and dynamism of its therapeutic research.’
  • Servier’s contribution to improving the management of disease in the UK remains a key priority, with products in the osteoporosis, cardiovascular and diabetes therapy areas.

  • To coincide with the launch of Protelos, celebrity personal trainer Matt Roberts has developed a programme of simple bone building exercises. Women can obtain a copy of the Matt Roberts bone building exercise programme by sending a stamped addressed envelope to: ATHENA FREEPOST ADDRESS

REFERENCES

  1. Marie PJ, Ammann P, Boivin G, Rey C. Calcif Tissue Int 2001; 69: 121-129
  2. Dahl SG, Allain P,Marie PJ et al. Bone 2001; 28: 446-453
  3. National Osteoporosis Website. What is osteoporosis: What is it. (Last accessed March 04)
  4. Rowe R. Brit Clin Pract 1996; 50: 47-49
  5. Cooper C, Atkinson EJ, Jacobsen SJ, O’Fallon WM, Melton LJ 3rd. Am J Epidemiol 1993; 137: 1001-1005
  6. Meunier PJ, Roux C, Seeman E et al. New England Journal of Medicine 2004; 350: 459-468
  7. Reginster JY.. 4th European Congress of Rheumatology, Lisbon 18-21 June 2003
  8. E. Seemanet al.Abstract 855 presented at the 26th Annual Meeting of the ASBMR, 01-05 Oct 2004, Seattle, USA.

04PR185 Date of Prep November 2004. For use on 22/111/04

Last updated 08/11/04