Protelos(R) (Strontium Ranelate) Builds Stronger Bone Compared to Bisphosphonates

ROME, June 19, 2010 - The osteoporosis treatment Protelos(R) (strontium ranelate, Servier) has
greater effects than the commonly prescribed bisphosphonate alendronate on
bone microarchitecture (cortical thickness, trabecular and cortical density)
in postmenopausal women according to a two-year study presented today at the
European Congress of Rheumatology (EULAR) in Rome.[1]

Results of this head-to-head study of 88 women show that, according to
bone scans (HR-pQCT technology), cortical thickness (p<0.05), trabecular bone
fraction (p<0.05), trabecular and cortical bone densities (p<0.05), increased
significantly more in women treated with Protelos, compared to those treated
with the bisphosphonate. This effect is significant within three months of
treatment. These new results reinforce the recently published, one-year
results of the same study and even demonstrate that the effect on bone in
favour of Protelos increases with time.[2]

"From these results, strontium ranelate appears to have a greater effect
than the bisphosphonate alendronate on tibia bone microstructure after two
years of treatment. Improving bone microarchitecture reduces the risk of
fractures, as there is a strong association between improving the structure
of bone and fracture risk reduction," points out Professor Rene Rizzoli,
Chairman of the Division of Bone Diseases at the University Hospital, Geneva,
Switzerland and President of The Foundation for Research in Osteoporosis and
Bone Disease.

The link between bone structure and fractures

There is a strong link between bone micro-architecture, a component of
bone quality and hence bone strength, and fracture risk reduction.

Postmenopausal women have been found to have significantly lower bone
density, trabecular number and cortical thickness than premenopausal women at
both the radius and tibia. In addition, although spine and hip bone mineral
density have been found to be similar in osteopenic women with or without
fractures, fractured women have lower trabecular density and more
heterogeneous trabecular distribution at the radius compared to women with no
fractures.[3] Protelos, the only antiosteoporotic agent that rebalances bone
turnover in favour of bone formation, improves the bone microarchitecture, in
particular cortical thickness. These improvements lead to increased bone
strength that contributes in high and sustained anti-fracture efficacy.

Unrivalled proof of efficacy against fractures

Protelos has been shown to be well-tolerated and easy-to-use for
patients.[4] Protelos' antifracture efficacy was highlighted in the European
osteoporosis diagnosis and treatment guidance. This guidance shows that
Protelos has a broader range of efficacy compared to the other
anti-osteoporotic agents and it has been proven to be effective in treating
fractures at vertebral, non-vertebral and hip sites.[5] A recent assessment
of currently available osteoporosis treatments studied the number of patients
needed to treat over a fixed time to prevent one fracture (NNT). Clearly, the
lower the number, the more efficacious the osteoporosis treatment in the
population studied. The analysis found that Protelos (2g / day) has a very
low NNT among the different osteoporosis treatments studied for the
prevention of both vertebral and hip fracture.[6] Only 9 patients would need
to be treated for 3 years with Protelos in order to prevent a new vertebral
fracture. Furthermore, Protelos has been shown to provide efficacy against
fractures independent of baseline risk factors such as age, bone mineral
density, prevalent fractures and a family history of osteoporosis.[7] The
anti-fracture efficacy has also been shown to be sustained over eight years,
making it the treatment with such unique proof of long term antifracture
efficacy. Long term efficacy is an important consideration in treatment
choice given the question marks over the long term safety of other
treatments.[8]

Notes to editors

Osteoporosis - a common, debilitating disease

Osteoporosis is a chronic condition due to decreased bone mass, leading
to reduced bone strength and fracture risk. Because women are particularly
susceptible to bone loss after the menopause, by far the most common form is
postmenopausal osteoporosis. The estimated lifetime risk of wrist, vertebral
or hip fracture in Caucasian women over 50 is 45%. The annual incidence rate
of osteoporotic fractures in women is greater than the combined incidence
rates of heart attack, stroke and breast cancer.[9] Postmenopausal
osteoporosis has a huge impact on healthcare budgets, which are already
expected to double for osteoporosis by the year 2050.

Protelos is marketed by independent French pharmaceutical company,
Servier. It is licensed for the treatment of postmenopausal osteoporosis to
reduce the risk of vertebral and hip fractures. It is currently registered
worldwide and launched in 72 countries.

Protelos is also sold under the trade names Protos(R), Osseor(R),
Bivalos(R) and Protaxos(R).

    References
    ---------------------------------

    [1] Rizzoli R, Felsenberg D, Laroche M et al. Superiority of strontium
        ranelate as compared to alendronate on microstructural determinants
        of bone strength at the distal tibia in women with postmenopausal
        osteoporosis. Abstract presented at EULAR Congress 2010.
    [2] Rizzoli R, Laroche M, Krieg MA, et al. Rheumatol Int. 2010 May 29.
        [Epub ahead of print]
    [3] Boutroy S et al. In vivo assessment of trabecular bone
        microachitecture by high-resolution peripheral quantitative computed
        tomography. J Clin Endocrinol Metab 2005;90(12):6508-6515
    [4] Protelos European Summary of Product Characteristics.
    [5] Kanis JA, Burlet B, Cooper C et al. European guidance for
        the diagnosis and management of osteoporosis in post menopausal
        women. Osteoporosis International 2008; 19(4):399-428.
    [6] Ringe JD, Doherty JG. Absolute risk reduction in osteoporosis:
        assessing treatment efficacy by number needed to treat. 2010;30: Epub
        ahead of print
    [7] Roux C, Reginster JY, Fechtenbaum J et al. Vertebral fracture risk
        reduction with strontium ranelate in women with postmenopausal
        osteoporosis is independent of baseline risk factors. J Bone Miner
        Res. 2006;21:536-542.
    [8] Reginster JY, Sawicki A, Roces - Varela A. Strontium ranelate: 8
        years efficacy on vertebral and nonvertebral fractures in post
        menopausal osteoporotic women. Osteoporos Int. 2008;19(Suppl.1):
        S131-S132 (Abstract P311)
    [9] Riggs BL and Melton LJ, 1995, Bone 17(S5):505S; From American Heart
        Association, Heart & Stroke Facts 1996; From American Cancer Society,
        Cancer Facts & Figures, 1996

For further information, please contact: Monica Gounaropoulos, Tonic Life Communications - +44-207-798-9910, monica.g at toniclc.com or Natalie Fairbank, Tonic Life Communications - +44-207-798-9938 natalie.fairbank at toniclc.com .