Investor Update
Basel, 27 February 2004
European
Commission Approves Daily Bonviva for the Treatment and Prevention of Post Menopausal Osteoporosis
Key
milestone in the development of a drug that aims to provide convenient treatment options for patients
and physicians
Roche announced today that they have received approval from the European Commission to market once-daily Bonviva (ibandronate) for the treatment and prevention of post menopausal osteoporosis. A positive opinion for Bonviva was received from the Committee for Proprietary Medicinal Products (CPMP) in October last year and the US Food and Drug Administration (FDA) approved a once-daily formulation of ibandronate (Boniva) in May 2003. The European approval was based on data showing once-daily Bonviva, a new bisphosphonate, provided a 62 percent relative reduction in the incidence of new vertebral fractures with postmenopausal osteoporosis, as well as a favourable tolerability profile.
These approvals mark the first milestone in the progress in developing this medicine. Roche and GSK are continuing to study more convenient dosing regimens that have the potential to offer enhanced patient convenience and compliance. As announced on 13 January, 2004 a recent study (MOBILE) investigating more convenient once-monthly oral treatment of post menopausal osteoporosis with ibandronate demonstrated efficacy and tolerability at least equivalent to the daily regimen.
Once daily Phase III
study (BONE, 4411)
In the three-year study, post menopausal women between age 55
and 80 with osteoporosis were treated with either placebo (n= 975) or daily oral ibandronate 2.5mg (n=
977). All women received daily oral calcium (500mg) and vitamin D (400IU). The primary endpoint of the
study was the incidence of new vertebral fracture after three years.
The
cumulative incidence of new vertebral fractures in the placebo group was 9.6% over 3 years and 4.7%
in the 2.5 mg. daily group. Daily oral ibandronate significantly reduced the relative risk of radiologically
confirmed vertebral fracture by 62 percent when compared to placebo. Treatment with 2.5mg daily ibandronate
also resulted in significant increases in bone mineral density at the lumbar spine and the hip and in
decreases in markers of bone turnover to levels similar to those in pre-menopausal women. In this study,
ibandronate demonstrated a favourable tolerability profile.
About
Osteoporosis
Osteoporosis is a disease characterised by low bone mass and increased
fragility and a consequent increase in fracture risk and disability. It is estimated that 1 out of 3
postmenopausal women aged 50 years and older is affected by osteoporosis. One in two women over the
age of 50 will have an osteoporosis-related fracture in their lifetime. Approximately 80% of people
with osteoporosis are women and 20% are men.
About
Bonviva
Bonviva a potent bisphosphonate, has been studied to date in clinical trials
involving over 9,000 patients. The ongoing clinical development programme is evaluating monthly oral
and intermittent intravenous dosage regimens in women with postmenopausal osteoporosis.
Bonviva is indicated for the treatment and prevention of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, Bonviva increases bone mineral density (BMD) and reduces the incidence of vertebral fractures. Bonviva is also indicated for use in postmenopausal women who are at risk of developing osteoporosis and for whom the desired clinical outcome is to maintain bone mass and reduce the risk of vertebral fracture.
About the Roche/GSK Collaboration
In
December 2001, Roche and GSK announced that they would co-develop and co-promote Bonviva for the treatment
and prevention of postmenopausal osteoporosis in all countries, except Japan. The Roche/GSK collaboration
provides expertise and commitment to bring new osteoporosis therapies to market as quickly as possible.
About
Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading
innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche
is number one in the global diagnostics market, the leading supplier of pharmaceuticals for cancer and
a leader in virology and transplantation. As a supplier of products and services for the 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 employs roughly 65,000 people in 150 countries. The Group has alliances
and R&D agreements with numerous partners, including majority ownership interests in Genentech and
Chugai.
About GlaxoSmithKline
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.
Note
to editors:
- BMD (Bone mineral density), measured by densitometry, gives an accurate
and precise measurement of the amount of bone.
- The name “Bonviva” has been approved
in Europe and the name “Boniva” is approved in the US.
All trademarks used or mentioned in this release are legally protected.