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Investor Update

Basel, 19 September 2006

Once monthly oral Bonviva continues to be highly effective and well tolerated in the long-term treatment of osteoporosis

New findings from the first year of the MOBILE LTE study show that once-monthly oral Bonviva continues to be highly effective at strengthening bone in the spine and hip by increasing bone mineral density (BMD). Bonviva was also well tolerated over the total three year period.

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The findings of the MOBILE LTE (Monthly Oral iBandronate In LadiEs Long Term Extension) study were presented today for the first time at the 28th Meeting of the American Society of Bone Mineral Research (ASBMR).

The MOBILE LTE study was designed to continue to assess the long-term efficacy of Bonviva in some patients from the earlier two year MOBILE study, by measuring BMD improvements over an additional three year period. BMD is an established means of assessing the effectiveness of osteoporosis treatments.  In the same way that cholesterol is used to predict cardiovascular disease, BMD is utilised by physicians to predict fracture risk.  

Sustained efficacy at hip and spine and good tolerability over three years

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After the first year of the MOBILE LTE study, BMD had increased at the lumbar spine by an additional 1.5% and by 0.3% at the total hip in those receiving Bonviva 150mg once-monthly. These are further improvements from the two year BMD increases of 6.6% at the lumbar spine and 4.2% at the total hip, which therefore illustrate the long-term efficacy of once-monthly oral Bonviva.

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 Throughout the MOBILE study, monthly ibandronate was found to have a tolerability profile similar to that of the daily regimen, which has a tolerability profile similar to placebo.

These important findings demonstrate that once-monthly oral Bonviva is highly effective at increasing BMD at the hip and spine (the sites where women with osteoporosis are most likely to break their bones) and has a good tolerability profile over three years. This is important because side effects are cited by patients as one of the major reasons why they don’t continue with their osteoporosis treatment.

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Professor Paul Miller from the Colorado Center for Bone Research and lead author of the MOBILE study says: “These new findings from the MOBILE LTE study provide important information for physicians who can be confident that, with once-monthly oral Bonviva, their patients will benefit from a treatment that is highly effective over a sustained period, and is well-tolerated.”  

Professor Miller continued: “Tolerability is particularly important in treating postmenopausal osteoporosis as we know that the occurrence of side effects is one of the main reasons patients stop taking their treatment. It may be that taking a tablet once a month, rather than more frequently, ultimately helps patients to stay on therapy so that they may gain maximum benefits.”

Once-monthly oral Bonviva is preferred by patients and helps them to stay on treatment

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Further information presented at ASBMR has shown that the convenience of less frequent dosing and, subsequently, less exposure to potential side effects associated with bisphosphonate treatments, are the main reasons that patients prefer once-monthly oral Bonviva.

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 This patient preference was also demonstrated in two robust clinical studies where more than 70% of patients selected the once-monthly oral Bonviva regimen as their preferred option over a weekly bisphosphonate treatment regimen.

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In addition, data presented at ASBMR for the first time on Sunday 17th September 2006 showed that patients taking once-monthly oral Bonviva were approximately 25% more likely to stay on their treatment during the first six months relative to women taking the weekly treatments, alendronate or risedronate.

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  Similar to the improvements in persistence observed with the introduction of weekly treatments compared to the previously-used daily regimens, these results show that once-monthly oral Bonviva has the potential to help patients stay on their osteoporosis treatment.

About MOBILE
• MOBILE (Monthly Oral iBandronate In LadiEs) was a randomised, double-blind trial comparing the efficacy and safety of monthly oral doses of Bonviva (100mg on a single day; 100mg as separate 50mg doses on two consecutive days; or 150mg on a single day) versus the oral daily regimen (2.5mg).  The MOBILE study was a two-year study involving 1,609 patients.

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About MOBILE LTE
• In order to provide further data on the long-term efficacy of Bonviva, the MOBILE study was extended and eligible patients continued with treatment, randomised to either 100mg or 150mg monthly ibandronate for a further 3 years (MOBILE long-term extension [LTE] study).
• The results from the first year of the MOBILE (LTE) study confirm that once-monthly oral Bonviva continues to be effective at increasing both lumbar spine and hip BMD, after long-term therapy.

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• Patients treated for a total of three years had an additional mean increase in lumbar spine BMD of 1.5% compared with BMD after two years, and an additional increase in total hip BMD of 0.3% over the two year measurement.

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About Bonviva
• Bonviva is the first and only once-monthly bisphosphonate indicated for the treatment of osteoporosis in postmenopausal women.
• Bonviva, a potent and highly effective bisphosphonate, has been studied to date in clinical trials involving over 13,000 patients.
• Bonviva, a highly effective bisphosphonate, works by reducing elevated bone turnover and increasing bone mineral density (BMD).
• Bonviva has shown a vertebral fracture risk reduction of 62%.

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 This study was designed to investigate vertebral efficacy and did not show an overall effect at the hip. However, a non-vertebral fracture risk reduction of 69% was observed in a sub-group at high-risk of fractures.

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• Bonviva is the only nitrogen containing bisphosphonate that has demonstrated a reduction in vertebral fracture risk using a drug-free interval of more than one day.

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• Bonviva, like other bisphosphonates administered orally, may cause upper gastrointestinal disorders such as dysphagia, oesophagitis and oesophageal or gastric ulcer.
• Once-monthly oral Bonviva received European Union approval in September 2005 and Swiss medic approval in August 2005. Once monthly Boniva (the brand name in the US) received FDA approval in March 2005.

Roche/GSK Collaboration
In December 2001, F Hoffmann-La Roche (Roche) and GlaxoSmithKline (GSK) announced their plans to co-develop and co-promote Bonviva for the treatment and prevention of postmenopausal osteoporosis in a number of major markets, excluding Japan. The Roche/GSK collaboration provides expertise and commitment to bringing new osteoporosis therapies to market as quickly as possible.

About Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2005 sales by the Pharmaceuticals Division totalled 27.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.2 billion Swiss francs. Roche employs roughly 70,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet (www.roche.com).

About GSK
GSK, 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.
All trademarks used or mentioned in this release are legally protected.

Further information
- Roche Healthkiosk, Osteoporosis
- GSK website



References
1. Miller PD, Luckey M, Cooper C, Stakkestad JA, Hughes C, Bolognese M. The MOBILE study long-term extension: progressive bone density gains with 150mg once-monthly oral ibandronate. Abstract presented at 28th Annual Meeting of the American Society for Bone and Mineral Research, Philadelphia, USA 15-19 September 2006.
2. Reginster JY, Adami S, Lakatos P, Greenwald M, Stepan JJ, Silverman SL et al. Efficacy and tolerability of once-monthly oral ibandronate in postmenopausal osteoporosis:2 year results from the MOBILE study. Ann Rheum Dis.2006; 65:654–66.
3. Silverman S, Emkey R, Reginster JY, Lorenc R, Hughes C, Kendler D. Adverse event profile with once-monthly oral ibandronate: the MOBILE study long-term extension. Abstract presented at 28th Annual Meeting of the American Society for Bone and Mineral Research, Philadelphia, USA 15-19 September 2006.
4. Dore RK. Reasons for patient preference for once-monthly ibandronate. Abstract presented at 28th Annual Meeting of the American Society for Bone and Mineral Research, Philadelphia, USA 15-19 September 2006.
5. Emkey R, Koltun W, Beusterien K, Seidman L, Kivitz A , Devas V et al. Patient preference for once-monthly ibandronate versus once-weekly alendronate in a randomized, open-label, cross-over trial: the Boniva Alendronate Trial in Osteoporosis (BALTO). Current Medical Research and Opinion 2005; 21 (12): 1895–1903.
6. Hadji P, Benhamou C-L, Devas V, Masanauskaite D, Barrett-Connor E. Women with postmenopausal osteoporosis prefer once-monthly oral ibandronate to weekly oral alendronate: Results of BALTO II. Abstract presented at 6th European Congress on Clinical and Economic Aspects of Osteoporosis and Osteoarthritis, Vienna, Austria 15-18 March 2006.
7. Silverman SL, Chesnut CH, Amonkar MM, Margolis J, Barr CE. Improved persistence in women with postmenopausal osteoporosis treated with once-monthly ibandronate versus weekly bisphosphonates: a first look. Abstract presented at 28th Annual Meeting of the American Society for Bone and Mineral Research, Philadelphia, USA 15-19 September 2006.
8. Chestnut C, Skag A,Christiansen C, Recker R, Stakkestad J, Hoiseth A et al. Effects of oral ibandronate administered daily or intermittently on fracture risk in postmenopausal osteoporosis. Journal of Bone and Mineral Research. 2004; 9 (8): 1241-1249.