Investor Update
Basel, 13 January 2004
New
phase III study successfully shows benefit of oral monthly Bonviva/Boniva in management of osteoporosis
First
osteoporosis drug to show monthly dosing at least equivalent to daily dosing, with potential to offer
enhanced patient convenience
Roche and GlaxoSmithKline (GSK) announced today that the first phase III study (MOBILE) investigating more convenient once-monthly oral treatment of post menopausal osteoporosis has demonstrated the effectiveness and tolerability of Bonviva/Boniva (ibandronate) after one year of treatment. All doses studied (100 mg and 150 mg once monthly) were at least equivalent to the 2.5 mg daily regimen in increasing spine Bone Mineral Density (BMD). Preliminary safety evaluation indicates that all regimens were well tolerated. The availability of less frequent dosing of Bonviva /Boniva has the potential to offer enhanced patient convenience and compliance.
The US Food and Drug Administration (FDA) approved a once-daily formulation of Boniva in May 2003 and Bonviva has recently received a positive opinion from the CPMP. The companies have been exploring more convenient dosing before launching the product.
“We are pleased that this initial review of the data indicates that a monthly dosing regimen with ibandronate shows promise in the management of post menopausal osteoporosis,” commented William M. Burns, Head of Roche Pharmaceuticals Division. “We will be sharing these data with the regulatory authorities at the earliest possible opportunity to supplement the initial daily filing.”
MOBILE
Study Details
The MOBILE1 (Monthly Oral Ibandronate in Ladies) is a 2 year randomised,
double-blind, parallel group, multinational study in postmenopausal women that compares the efficacy
and safety of the FDA approved oral daily ibandronate regimen with three different monthly regimens:
-
100 mg on a single day
- 100 mg as separate 50 mg doses on two consecutive days
-
150 mg on a single day
MOBILE is a non-inferiority study with lumbar spine Bone Mineral
Density (BMD) at one year as the primary endpoint. The study is currently ongoing for a second year.
About
Bonviva/Boniva
Bonviva/Boniva, 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 quarterly intravenous dosage regimens in women with postmenopausal osteoporosis.
Bonviva/Boniva
is indicated for the treatment and prevention of osteoporosis in postmenopausal women. In postmenopausal
women with osteoporosis, Bonviva/Boniva increases bone mineral density and reduces the incidence of
vertebral fractures. Bonviva/Boniva also may be considered for 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/Boniva 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.
All trademarks used or mentioned in this release are legally protected.
Note
to editors:
- BMD (Bone mineral density), measured by densitometry, gives an accurate
and precise measurement of the amount of bone.
- The name “Boniva” has been approved
in the US and the name “Bonviva” is approved in Europe
References
1)
Cooper C et al. Oral monthly ibandronate in post-menopausal osteoporosis: rationale and design of the
MOBILE study. Poster, ECCEO, Nice 2003.
Further Information: