An intravenous (I.V.) injection of the new osteoporosis
drug called Bonviva (ibandronate), administered every two or three
months, has been shown to be highly effective and well- tolerated over
two years1. These results, from the DIVA study, were presented at the
annual meeting of the American College of Rheumatology in San Diego, USA
and suggest that the I.V. formulation of ibandronate may offer an
effective alternative for a select group of women with postmenopausal
osteoporosis who are unable to take oral bisphosphonates.
Pierre Delmas, Professor of Medicine and Rheumatology and Director of the INSERM Research Unit in Lyon commented on the implication of these results: "These findings are very exciting, as they confirm Bonviva I.V. injection has the potential to bring the long term bone strengthening benefits of bisphosphonate therapy to those women who are unable to stay upright for the required length of time* or have another medical condition which means they are unable to take an oral bisphosphonate. In addition, the clinician can be certain that the patient receives a therapeutic dose as part of an ongoing treatment regimen."
DIVA (Dosing IntraVenous Administration) studied the efficacy, safety and tolerability of two novel I.V. regimens - 2mg every two months or 3mg every three months. When compared to the once- daily oral formulation of ibandronate (which in previous studies has been shown to reduce the risk of vertebral fracture in women with postmenopausal osteoporosis by 62% over three years) both I.V. ibandronate regimens:
- - Demonstrated significantly greater increases in bone mineral density (BMD) at the lumbar spine
- - Showed consistently greater increases in BMD at all hip sites measured
- - Were well-tolerated, with similar overall rates of adverse events The most common side effects for I.V. ibandronate were bone, muscle or joint pain, flu-like illness and headache.1 Ibandronate I.V. injection is administered as a 15-30 second injection.
Regulatory files have been submitted to both the US and the European Union Health Authorities.
This announcement comes soon after the EU Commission granted marketing authorization (September 15th) for the unique once-monthly oral formulation of Bonviva. Approval was based on the 2-year results of a phase III study called MOBILE (Monthly Oral iBandronate In LadiEs). These results are also being presented at the ACR meeting. The 2-year results from MOBILE show that the monthly dose of Bonviva provides a significantly superior increase in BMD at the lumbar spine compared to the daily dose. The monthly dose of Bonviva was also well- tolerated, which is an important consideration for women taking medication for the long-term.2
Both the monthly oral and I.V. formulations represent important advances in the treatment of osteoporosis, as many patients discontinue daily and weekly osteoporosis therapy for convenience reasons. This may help to explain why more than half the patients with postmenopausal osteoporosis stop taking their once-daily or once-weekly bisphosphonate treatment within a year3, foregoing the bone-building benefits these drugs can only provide over time.4
About Bonviva I.V. injection
The regulatory submissions for Bonviva I.V.injection include the first year results of the DIVA study, released in July 2004. The NDA for Boniva I.V. injection was submitted to the FDA in the US in December 2004. The MAA for Bonviva I.V. injection was submitted to the EMEA in Europe in April 2005. Bonviva I.V. injection is administered as a 15-30 second injection, making it simple and convenient for administration.
About DIVA
DIVA (Dosing IntraVenous Administration) is a multinational, randomised, double-blind, active control multicentre study in 1,395 women with postmenopausal osteoporosis aged between 55 and 80 years of age. DIVA aims to compare the safety, efficacy and tolerability of the approved oral daily ibandronate 2.5mg regimen with two novel I.V. regimens: 2mg every two months and 3mg every three months, with lumbar spine BMD at one year as the primary endpoint.
The two-year findings from the study were presented at the ACR meeting. BMD at the lumbar spine increased more in the 2mg and 3mg I.V. dosing groups than in the daily oral dosing group (6.4 % and 6.3 % vs. 4.8 %, respectively). As at 1 year, the I.V. regimens were shown to be at least as good as the daily regimen (margin at year 2: 1.3%) and both I.V. regimens were actually superior (p<0.001) to the oral regimen. Substantial increases in bone density at the hip were also observed, and were also greater in the I.V. groups than in the oral daily regimen (3.4 % and 3.1 % vs. 2.2%, respectively). Clinically relevant decreases in bone breakdown (as measured by the biochemical marker of bone resorption, serum CTX) were observed in all three treatment groups. Both I.V. regimens were well tolerated.
About MOBILE
MOBILE (Monthly Oral iBandronate In LadiEs) is a randomised, double-blind trial 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), approved by the FDA and European Commission, in 1,609 women with postmenopausal osteoporosis. The primary endpoint was analysed at 1 year. One year results from MOBILE were recently published in the Journal of Bone and Mineral Research and full two year results were presented at the Annual European Congress of Rheumatology, Vienna, Austria 8-11 June 2005.
Roche/GSK Collaboration
In December 2001, F. Hoffmann-La Roche Ltd (Roche) and GlaxoSmithKline (GSK) announced their plans to co-develop and co-promote Bonviva for the treatment and prevention of postmenopausal osteoporosis in a number of major markets, excluding Japan. The Roche/GSK collaboration provides expertise and commitment to bringing new osteoporosis therapies to market as quickly as possible.
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 diseases, 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 drugs 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 (http://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.
Pierre Delmas, Professor of Medicine and Rheumatology and Director of the INSERM Research Unit in Lyon commented on the implication of these results: "These findings are very exciting, as they confirm Bonviva I.V. injection has the potential to bring the long term bone strengthening benefits of bisphosphonate therapy to those women who are unable to stay upright for the required length of time* or have another medical condition which means they are unable to take an oral bisphosphonate. In addition, the clinician can be certain that the patient receives a therapeutic dose as part of an ongoing treatment regimen."
DIVA (Dosing IntraVenous Administration) studied the efficacy, safety and tolerability of two novel I.V. regimens - 2mg every two months or 3mg every three months. When compared to the once- daily oral formulation of ibandronate (which in previous studies has been shown to reduce the risk of vertebral fracture in women with postmenopausal osteoporosis by 62% over three years) both I.V. ibandronate regimens:
- - Demonstrated significantly greater increases in bone mineral density (BMD) at the lumbar spine
- - Showed consistently greater increases in BMD at all hip sites measured
- - Were well-tolerated, with similar overall rates of adverse events The most common side effects for I.V. ibandronate were bone, muscle or joint pain, flu-like illness and headache.1 Ibandronate I.V. injection is administered as a 15-30 second injection.
Regulatory files have been submitted to both the US and the European Union Health Authorities.
This announcement comes soon after the EU Commission granted marketing authorization (September 15th) for the unique once-monthly oral formulation of Bonviva. Approval was based on the 2-year results of a phase III study called MOBILE (Monthly Oral iBandronate In LadiEs). These results are also being presented at the ACR meeting. The 2-year results from MOBILE show that the monthly dose of Bonviva provides a significantly superior increase in BMD at the lumbar spine compared to the daily dose. The monthly dose of Bonviva was also well- tolerated, which is an important consideration for women taking medication for the long-term.2
Both the monthly oral and I.V. formulations represent important advances in the treatment of osteoporosis, as many patients discontinue daily and weekly osteoporosis therapy for convenience reasons. This may help to explain why more than half the patients with postmenopausal osteoporosis stop taking their once-daily or once-weekly bisphosphonate treatment within a year3, foregoing the bone-building benefits these drugs can only provide over time.4
About Bonviva I.V. injection
The regulatory submissions for Bonviva I.V.injection include the first year results of the DIVA study, released in July 2004. The NDA for Boniva I.V. injection was submitted to the FDA in the US in December 2004. The MAA for Bonviva I.V. injection was submitted to the EMEA in Europe in April 2005. Bonviva I.V. injection is administered as a 15-30 second injection, making it simple and convenient for administration.
About DIVA
DIVA (Dosing IntraVenous Administration) is a multinational, randomised, double-blind, active control multicentre study in 1,395 women with postmenopausal osteoporosis aged between 55 and 80 years of age. DIVA aims to compare the safety, efficacy and tolerability of the approved oral daily ibandronate 2.5mg regimen with two novel I.V. regimens: 2mg every two months and 3mg every three months, with lumbar spine BMD at one year as the primary endpoint.
The two-year findings from the study were presented at the ACR meeting. BMD at the lumbar spine increased more in the 2mg and 3mg I.V. dosing groups than in the daily oral dosing group (6.4 % and 6.3 % vs. 4.8 %, respectively). As at 1 year, the I.V. regimens were shown to be at least as good as the daily regimen (margin at year 2: 1.3%) and both I.V. regimens were actually superior (p<0.001) to the oral regimen. Substantial increases in bone density at the hip were also observed, and were also greater in the I.V. groups than in the oral daily regimen (3.4 % and 3.1 % vs. 2.2%, respectively). Clinically relevant decreases in bone breakdown (as measured by the biochemical marker of bone resorption, serum CTX) were observed in all three treatment groups. Both I.V. regimens were well tolerated.
About MOBILE
MOBILE (Monthly Oral iBandronate In LadiEs) is a randomised, double-blind trial 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), approved by the FDA and European Commission, in 1,609 women with postmenopausal osteoporosis. The primary endpoint was analysed at 1 year. One year results from MOBILE were recently published in the Journal of Bone and Mineral Research and full two year results were presented at the Annual European Congress of Rheumatology, Vienna, Austria 8-11 June 2005.
Roche/GSK Collaboration
In December 2001, F. Hoffmann-La Roche Ltd (Roche) and GlaxoSmithKline (GSK) announced their plans to co-develop and co-promote Bonviva for the treatment and prevention of postmenopausal osteoporosis in a number of major markets, excluding Japan. The Roche/GSK collaboration provides expertise and commitment to bringing new osteoporosis therapies to market as quickly as possible.
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 diseases, 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 drugs 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 (http://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.
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