Bonviva(R) once-monthly oral treatment for osteoporosis is 'highly effective' over two years

Main Category: Bones / Orthopedics
Article Date: 09 Jun 2005 - 15:00 PST

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GlaxoSmithKline (GSK) have announced new results from the landmark MOBILEphase III study. The data, presented for the first time today at the Annual European Congress of Rheumatology (EULAR), confirm Bonviva(R)(ibandronate), intended as a once-monthly oral treatment for postmenopausal osteoporosis, is highly effective and well tolerated over two years.1

The two year study results show once monthly oral Bonviva is at least as effective as the approved once daily oral Bonviva.1 The 150mg Bonviva monthly regimen, approved in the USlast month, was prospectively demonstrated to be significantly better than the 2.5mg Bonviva daily regimen.1

-- Lumbar spine bone mineral density (BMD) increased in all groups: specifically, 5.6% and 6.6% in the 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).1

-- BMD at all regions of the hip increased for all treatment groups. Increases at the total hip were most pronounced in the 150mg group: 3.5% and 4.2% in the 100mg and 150mg once monthly groups respectively, compared with 2.5% in the daily group.1

-- Decreases in markers of bone turnover seen during the first year of MOBILE2,3,4,5 were maintained throughout the second year.1

-- 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.1

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.1

-- No unexpected significant upper gastro-intestinal (GI) safety concerns were identified and there were very few withdrawals due to adverse effects.1

William 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.2"

Current bisphosphonate therapies are available as daily and weekly dosing formulations. The US Food and Drug Administration approved once-monthly oral Boniva(R) 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 MOBILEwere presented in 2004 at the 26th Annual Meeting of the American Society for Bone Mineral Research, Seattle, USA. 3,4,5,6

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(R) in March 2005. Bonviva is not yet approved as a once-monthly formulation in Europebut 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.7

-- 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, USAand Japan.8

-- 1/3 of women over 50 will experience osteoporotic fractures.8

Osteoporosis is a common and chronic condition.8

-- Like many chronic conditions, over half of all patients prescribed daily or weekly osteoporosis treatment stop taking their medicine within 12 months.9,10

-- This insufficient adherence to treatment can result in increased risk of further fractures.11,12

-- Taking tablets less often can assist patients to stay on their therapy.9,10

-- The cost to healthcare systems worldwide as a result of osteoporotic fractures is estimated to be in the billions of dollars each year.8

-- The prevalence of osteoporosis is growing, especially as the number of postmenopausal women in the population continues to rise.8

-- 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 2020.8

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.

About GSK

GlaxoSmithKline - 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:
health-kiosk.ch/start_osteo.htm

GSK website: http://www.gsk.com

Enquiries:
UK Media enquiries:
Philip Thomson (020) 8047 5502
David Mawdsley (020) 8047 5502
Chris Hunter-Ward (020) 8047 5502
Alice Hunt (020) 8047 5502

European Analyst/Investor enquiries:
Duncan Learmouth (020) 8047 5540
Anita Kidgell (020) 8047 5542
Jen Hill (020) 8047 5543

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. 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. 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.

4. 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.

5. 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.

6. 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

7. 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.

8. International Osteoporosis Foundation.

9. 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).

10. 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).

11. Caro JJ, Ishak KJ, Huybrechts KF, et al. The impact of compliance with osteoporosis therapy on fracture rates in actual practice. Osteoporos Int 2004.

12. 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.

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