Media Release

Basel, 26 May 2004

Supplemental new drug application for once-monthly Boniva in osteoporosis submitted to FDA

Roche and GlaxoSmithKline plc announced today 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.

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 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 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.

Note to Editors:
Boniva is the US tradename, Bonviva is the European tradename.