Investor Update
Basel, 9 June 2005 1 2 1 1 1 1 2,3,4,5 1 1 1
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
oche
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.
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.”
The
two year study results show once monthly oral Bonviva is at least as effective as the approved once
daily oral Bonviva.
•
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).
•
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.
• Decreases
in markers of bone turnover seen during the first
year of MOBILE
•
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.
•
No unexpected significant upper gastro-intestinal (GI) safety concerns were identified and there were
very few withdrawals due to adverse effects.
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.
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 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.
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, USA and 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. 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. 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.
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.
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