Roche and GlaxoSmithKline plc announced the submission of a supplemental new drug application (sNDA) with the U.S. Food and Drug Administration (FDA) for a novel once-monthly oral formulation of its bisphosphonate, Boniva tablets (ibandronate sodium), for the treatment and prevention of postmenopausal osteoporosis.

The FDA approved the once-daily formulation in May 2003, and the companies have been exploring more convenient dosing options before launching the product.

"Boniva is expected to be the first once-monthly treatment for osteoporosis, offering better convenience and potentially enhanced compliance to patients," commented William M. Burns, Head of Roche's Pharmaceuticals Division. "We plan to file once-monthly oral Bonviva in Europe later this year."

In December 2001, Roche and GSK announced that they would co-develop and co-promote 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.

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.