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Media Release

Basel, 9 June 2005

New data confirm once-monthly oral treatment for osteoporosis is ‘highly effective’ over two years

MOBILE 2-year results announced today reinforce efficacy, safety and tolerability of Bonviva

Roche and GlaxoSmithKline (GSK) have announced new results from the landmark MOBILE phase III study. The data, presented for the first time today at the Annual European Congress of Rheumatology (EULAR), confirm Bonviva (ibandronic acid), intended for once-monthly oral treatment for postmenopausal osteoporosis, is highly effective and well tolerated over two years.

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William M. Burns, CEO Division Roche Pharma, outlined the implications of these new data: “These new data confirm the one year results presented in 2004 and further strengthen the evidence for the first monthly oral treatment for osteoporosis. Bonviva offers the proven efficacy of a bisphosphonate with the convenience of just 12 tablets a year, which may help patients to stay on therapy longer. This is important because we know that more than 60% of patients who take a once-weekly bisphosphonate stop within a year”.

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The two year study results show once monthly oral Bonviva is at least as effective as the approved once daily oral Bonviva.

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 The 150mg Bonviva monthly regimen, approved in the US last month, was prospectively demonstrated to be significantly better than the 2.5mg Bonviva daily regimen.

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• Lumbar spine bone mineral density (BMD) increased in all groups: 5.3%, 5.6% and 6.6% in the 50+50 mg,100 mg and 150mg once monthly groups respectively, compared with 5.0% in the daily group. The 150mg regimen continued to be superior to daily Bonviva (p < 0.001).

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• BMD at all regions of the hip increased for all treatment groups, but increases were most pronounced in the 150mg group: 3.5% and 4.2% ,100 mg and 150mg once monthly groups respectively, compared with 2.5% in the daily group at the total hip

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• Decreases in markers of bone turnover seen during the first year of MOBILE

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 were maintained throughout the second year.

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• The majority of participants responded positively to oral ibandronate therapy. In the 150mg once-monthly group over 80% of patients maintained or gained BMD at all sites measured.

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These two year data also confirm the good tolerability previously seen at one year:
• Incidence of adverse events with once monthly oral Bonviva was similar to that seen in the daily group.

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• No unexpected significant upper gastro-intestinal (GI) safety concerns were identified and there were very few withdrawals due to adverse effects.

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Current bisphosphonate therapies are available as daily and weekly dosing formulations. The US Food and Drug Administration approved once-monthly oral Boniva 150 mg in March 2005. In September 2004 Roche and GlaxoSmithKline submitted a Marketing Authorization Application to European regulatory authorities for the once-monthly oral formulation.

About MOBILE
MOBILE (Monthly Oral iBandronate In LadiEs) is a two-year, randomized, double-blind trial in 1609 women with postmenopausal osteoporosis comparing the efficacy and safety of monthly oral doses of ibandronate (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), previously approved by the FDA and European Commission. The primary endpoint was at 1 year. One year results from MOBILE were presented in 2004 at the 26th Annual Meeting of the American Society for Bone Mineral Research, Seattle, USA.

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About Bonviva
• Bonviva, a potent bisphosphonate, has been studied to date in clinical trials involving over 11,000 patients.
• The ongoing clinical development programme is evaluating monthly oral and bi-monthly/quarterly intravenous dosage regimens in women with postmenopausal osteoporosis.
• Daily Bonviva, indicated for the treatment and prevention of osteoporosis in postmenopausal women, reduces bone turnover, increases bone mineral density and reduces the incidence of vertebral fractures
• The U.S. Food and Drug Administration gave approval for once-monthly Boniva in March 2005. Bonviva is not yet approved as a once-monthly formulation in Europe but a marketing authorization application was submitted in September 2004.
• Bonviva is the only bisphosphonate that has demonstrated a reduction in vertebral fracture risk using a drug-free interval of more than two months.

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• Studies specifically designed to demonstrate reductions in non-vertebral or hip fractures have not been conducted with Bonviva.
• Bonviva, like other orally administered bisphosphonates, may cause upper gastrointestinal disorders such as dysphagia, esophagitis and esophageal or gastric ulcer.

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 2004 sales by the Pharmaceuticals Division totalled 21.7 billion Swiss francs, while the Diagnostics Division posted sales of 7.8 billion Swiss francs. Roche employs roughly 65,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. For further information: www.roche.com

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



Additional information
- About postmenopausal osteoporosis: www.roche.com/mbosteop05e.pdf
- Roche Health Kiosk, Osteoporosis: www.health-kiosk.ch/start_osteo.htm
- GSK website: www.gsk.com


References
1. Cooper C, Delmas PD, Felsenburg D, Hughes C, Mairon N et al. Two-year efficacy and tolerability of once monthly oral ibandronate in postmenopausal osteoporosis: the MOBILE study. Abstract presented at the Annual European Congress of Rheumatology, Vienna, Austria 8-11 June 2005.
2. Miller PD, Drezner MK, Delmas PD, Stakkestad JA, Hughes C, Bonvoisin B, Reginster J-Y. Monthly oral ibandronate is at least as effective as oral daily ibandronate in postmenopausal osteoporosis: 1-year results from MOBILE. Poster F408, presented at: 26th Annual Meeting of the American Society for Bone Mineral Research, October 1-5, 2004, Seattle, WA.
3. Emkey R, Felsenberg D, Stepan JJ, Hughes C, Dumont E, Van der Auwera P, Recker RR. Once monthly dosing increases the proportion of patients who respond to oral ibandronate: 1-year results from MOBILE. Poster M432, presented at: 26th Annual Meeting of the American Society for Bone Mineral Research, October 1-5, 2004, Seattle, WA.
4. Recker RR, Kendler DL, Adami S, Hughes C, Dumont E, Schimmer RC, Cooper C. Monthly oral ibandronate significantly reduces bone resorption in postmenopausal osteoporosis: 1-year results from MOBILE. Poster F406, presented at: 26th Annual Meeting of the American Society for Bone Mineral Research, October 1-5, 2004, Seattle, WA.
5. Lewiecki EM, Miller PD, Lorenc R, Hughes C, Bonvoisin B, McClung MR. Monthly oral ibandronate is well tolerated in women with postmenopausal osteoporosis: 1-year results from MOBILE. Poster M429, presented at: 26th Annual Meeting of the American Society for Bone Mineral Research, October 1-5, 2004, Seattle, WA
6. Effects of Oral Ibandronate Administered Daily or Intermittently on Fracture Risk in Postmenopausal Osteoporosis. Chestnut et al, Journal of Bone & Mineral Research, vol. 10: 8, 2004.
7. International Osteoporosis Foundation.