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Media Release

Basel, 27 June 2005

Bonviva, the first once-monthly oral tablet for osteoporosis, receives positive opinion in Europe

Roche and GlaxoSmithKline (GSK) announced today that Bonviva (ibandronic acid), the first and only once-monthly tablet for the effective treatment of postmenopausal osteoporosis, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP).

With once-monthly Bonviva, a potent and highly effective bisphosphonate,

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patients will only have to take 12 tablets a year versus 52 required with current weekly bisphosphonate treatments. This is particularly important as almost two-thirds of patients stop taking their osteoporosis treatment within a year

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, foregoing the bone building benefits these drugs can provide over time

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 Data show that less frequent dosing has a positive impact on how long a patient continues to take a medication.2 On approval, Bonviva will be the first ever oral treatment administered as one tablet once a month for any disease.

William M. Burns, CEO Division Roche Pharma said, “Bonviva was developed in response to a clear patient need. When approved in Europe, once-monthly Bonviva will offer an effective and more convenient regimen which could help women to stay on therapy and get the bone protection they need.”

Adherence to current treatments sub-optimal
Other oral bisphosphonates, the most frequently prescribed medication for osteoporosis, are available only in daily and weekly dosage forms. Whilst more patients have been shown to stay on weekly treatment rather than daily treatment, it was shown that over 50% of patients quit taking their medication after one year.

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Positive opinion based on landmark MOBILE data
The CHMP positive opinion was based on the results from MOBILE (Monthly Oral iBandronate In LadiEs), a randomised, double-blind, multinational, non-inferiority trial in 1,609 women with postmenopausal osteoporosis. The MOBILE study showed that the monthly dose was at least as effective as the daily dose. In addition, the monthly dose resulted in even larger increases in Bone Mineral Density (BMD), at lumbar spine and all hip sites, when compared with the daily dose, and was statistically superior to the daily dose at all these sites after two years.

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Bonviva (known in the US as Boniva) was approved by the US Food and Drug Administration in March 2005. In the US, Boniva 150mg is indicated for the treatment of osteoporosis in postmenopausal women.

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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and full two year results were presented at the Annual European Congress of Rheumatology, Vienna, Austria 8-11 June 2005.

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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.
• Bonviva, indicated in Europe as a daily formulation 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. Boniva has been available in the US since late April 2005.
• Bonviva is the only bisphosphonate that has demonstrated a reduction in vertebral fracture risk using a drug-free interval of more than one week.

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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 post menopausal osteoporosis
Bone is constantly being rebuilt and goes through a balanced process of bone break-down and new bone formation. After menopause, this balance is disrupted and women loose bone faster than it is rebuilt. This imbalance can be easily measured by simple blood or urine tests. After years of bone loss, bones become brittle and more likely to break. The goal of osteoporosis treatment is to restore the bone balance hence increasing bone mass and consequently decreasing the risk of osteoporotic fractures.

• Osteoporosis affects an estimated 75 million people in Europe, USA and Japan.

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• 1/3 of women over 50 will experience osteoporotic fractures.

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• Osteoporosis is a common and chronic condition.

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• Like many chronic conditions, over half of all patients prescribed daily or weekly osteoporosis treatment stop taking their medicine within 12 months.

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• This insufficient adherence to treatment can result in increased risk of further fractures

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• Taking medication less often can assist patients to stay on their therapy.

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• The cost to healthcare systems worldwide as a result of osteoporotic fractures is estimated to be in the billions of dollars each year.

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• The prevalence of osteoporosis is growing, especially as the number of postmenopausal women in the population continues to rise.

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• An estimated 52 million women aged fifty plus are expected to be affected by osteoporosis and osteopenia by 2010 and 61 million are expected to be affected by 2020.

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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
- Roche Health-Kiosk, Osteoporosis
- GSK website


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 8-11June 2005.
2. DIN-LINK data, Compufile Ltd, January 2004. NB. Patients are excluded from the analysis at the point where they stop taking therapy altogether or have failed to comply fully.
3. Caro JJ, Ishak KJ, Huybrechts KF, et al. The impact of compliance with osteoporosis therapy on fracture rates in actual practice. Osteoporos Int 2004.
4. Sebaldt R, Shane L, Pham B, et al. Impact of non-compliance and non-persistence with daily bisphosphonates on longer-term effectiveness outcomes in patients with osteoporosis treated in tertiary specialist care. J Bone Miner Res 2004;19(Suppl. 1): (Abstract M423).
5. Cramer JA, Amonkar MM, Hebborn A, Suppapanya N. Does dosing regimen impact persistence with bisphosphonate therapy among postmenopausal osteoporotic women? J Bone Miner Res 2004;19(Suppl. 1):S448 (Abstract M434).
6. Data on file, NDC Health Study. (Ref. 161-011), Hoffmann-La Roche Inc., Nutley, NJ.
7. Ettinger M, Gallagher R, Amonkar M, et al. Medication persistence is improved with less frequent dosing of bisphosphonates, but remains inadequate. Arthritis Rheum 2004;15(Suppl):S513(Abstract 1325).
8. 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.
9. 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.
10. 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.
11. 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
12. Chestnut et al. Effects of Oral Ibandronate Administered Daily or Intermittently on Fracture Risk in Postmenopausal Osteoporosis. Journal of Bone & Mineral Research, vol. 10: 8, 2004.
13. International Osteoporosis Foundation.
14. McCombs JS, Thiebaud P, McLaughlin-Miley C, et al. Compliance with drug therapies for the treatment and prevention of osteoporosis. Maturitas 2004;48:271-87.