GlaxoSmithKline (GSK) and Roche announced that the first phase III study (MOBILE) investigating more convenient once-monthly oral treatment of post menopausal osteoporosis with Boniva/Bonviva (ibandronate) tablets has shown positive results 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 lumbar spine Bone Mineral Density (BMD). Preliminary safety evaluation indicates that all regimens were well tolerated.

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.

Many currently available osteoporosis treatments restrict patients' activities before and after taking their medicine, such as requiring them to fast and prohibiting them from reclining. While Boniva/Bonviva also has these restrictions on patient activity, the availability of less frequent dosing of Boniva/Bonviva may offer enhanced patient convenience.

"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 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."

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: