European positive opinion for first quarterly I.V. injection for postmenopausal osteoporosis

New Injection Could Bring Benefits of Bonviva® To More Women

Issued — 27th January 2006, Basel and London - GlaxoSmithKline (GSK) and Roche announced today that a new quarterly intravenous (I.V.) injection of the highly-effective osteoporosis medication Bonviva® (ibandronic acid) has been recommended for approval in the EU by the Committee for Medicinal Products for Human Use (CHMP). Once approved, this will be the first ever I.V. injection for the treatment of osteoporosis in postmenopausal women available in the EU.

Bonviva is already approved as an effective and well-tolerated1 once-monthly oral tablet in more than 38 countries. However, for some women with postmenopausal osteoporosis, oral bisphosphonates are not suitable. These women may be unable to take oral bisphosphonate therapy due to another medical condition or because they cannot stay upright for the required length of time.* For these women, Bonviva Injection offersa way to gain the proven bone strengthening benefits of bisphosphonate therapy.

Peter Matton, Roche’s Global Head for Bonviva commented: "We know there is a specific group of women who are unable to take oral bisphosphonates. This new quarterly injection of Bonviva allows them to also benefit from this effective class of osteoporosis treatment.”

Pierre Delmas, Professor of Medicine and Rheumatology and Director of the INSERMResearch Unit in Lyon, said: “Oral bisphosphonates are the most commonly prescribed treatment for postmenopausal osteoporosis. Furthermore, recent studies have shown women prefer Bonviva once-monthly to once-weekly oral bisphosphonate treatment, finding it more convenient.2** However, for those women who cannot take oral medication, a quarterly injection of Bonviva would provide healthcare professionals with an important, alternative treatment option.”

Bonviva Injection will be presented as a 3mg/3ml solution in a pre-filled syringe and is administered by a healthcare professional as an intravenous injection over 15-30 seconds once every three months.

The CHMP positive opinion was based on results from the 2 year DIVA (Dosing IntraVenous Administration) study.3 DIVA investigated the efficacy, safety and tolerability of Bonviva Injection in comparison to the once-daily oral formulation of Bonviva and found it to be highly effective and well-tolerated.3 Previous studies have shown that once-daily oral ibandronate reduced the risk of vertebral fracture in women with postmenopausal osteoporosis by 62% when taken over three years.4

NOTES TO EDITORS

Further background information can be provided upon request.

About DIVA

DIVA (Dosing IntraVenous Administration) is a multinational, randomised, double-blind, active control multicentre study in more than 1,300 women with postmenopausal osteoporosis aged between 55 and 80 years of age. DIVA compares the safety, efficacy and tolerability of the approved once-daily oral ibandronate 2.5mg regimen with two novel I.V. regimes: 2mg every two months and 3mg every three months, with lumbar spine bone mineral density (BMD) at one year as the primary endpoint.

The two-year findings from the study were presented at the 2005 Annual Scientific Meeting of the American College of Rheumatology, November 12-17 2005.3 For patients who received the 3mg ibandronate every 3 months dosing regimen:

* BMD at the lumbar spine increased more in the I.V. dosing groups than in the daily oral dosing group (6.3 percent vs. 4.8 percent).
* Substantial increases in bone density at the hip (a major non-vertebral site) were also observed, and were also greater in the I.V. group than in the oral daily regimen (3.1 percent vs. 2.2 percent).
* Clinically relevant decreases in bone breakdown (as measured by the biochemical marker of bone resorption, serum CTX) were observed in all treatment groups.

The I.V. regimen was well tolerated. The most common side effects for I.V. ibandronate werebone, muscle or joint pain, influenza-like symptoms and headache.

Regulatory Status

The CHMP has issued a positive opinion for Bonviva Injection. This is usually the final step towards approval in Europe. Once approved, Bonviva Injection will be indicated for the treatment of osteoporosis in postmenopausal women, in order to reduce the risk of vertebral fractures. Efficacy on femoral neck fractures has not been established. Boniva™ Injection was approved by the US Food and Drug Administration on 6th January 2006.

Roche/GSK Collaboration

In December 2001, F Hoffmann-La Roche (Roche) and GlaxoSmithKline (GSK) announced their plans to co-develop and co-promote Boniva 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 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 market leader in virology. For further information 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, Felsenberg D, Hughes C, Mairon N et al. Two-year efficacy and tolerability of once monthly oral ibandronate in postmenopausal osteoporosis: the MOBILEstudy. Abstract presented at the Annual European Congress of Rheumotology, Vienna, Austria8-11 June 2005.

2. Emkey R, Koltun W, Beusterien K, Seidman L, Kivitz A et al. Patient preference for once-monthly ibandronate versus one-weekly alendronate in a randomized, open-label, cross-over trial: the Boniva Alendronate Trial in Osteoporosis (BALTO). Current Medical Research and Opinions, 2005;21 (2): 1895 - 1903

3. Emkey R, Zaidi M, Lewiecki EM, Burdesk A, Mairon N, et al. Two-year efficacy and tolerability of intermittent intravenous ibandronate injections in postmenopausal osteoporosis: the DIVA study. Abstract presented at the Annual Meeting of the American College of Rheumatology, 12-17 November, 2005, San Diego, USA.

4. Chesnut C, Skag A, Christiansen C, Recker R, Stakkestad J et al. Effects of Oral Ibandronate Administered Daily or Intermittently on Fracture Risk in Postmenopausal Osteoporosis. Journal of Bone & Mineral Research, 2004; 10, (8), 1421-1429

*Oral bisphosphonates are taken according to a very strict treatment regime which involves remaining upright and not eating, drinking (except water) or taking other medications for a period of time before and after the therapy has been taken.

Contact Information

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