FDA Approval of Boniva

GlaxoSmithKline PLC 29 March 2005 FDA Approves Once-Monthly Boniva(R) for Osteoporosis in the U.S. First-Ever Monthly Single Tablet for Any Disease LONDON, UK (March 25, 2005) - The U.S. Food and Drug Administration (FDA) today approved once-monthly oral Boniva(R) (ibandronate sodium) 150 mg Tablets, the first and only once-monthly medicine for the treatment of postmenopausal osteoporosis, GlaxoSmithKline (GSK) announced. Boniva is the first-ever oral treatment administered as one tablet once a month for any chronic disease. With once-monthly Boniva, an effective bisphosphonate, patients would take 12 tablets a year versus 52 required with current weekly bisphosphonate treatments. The U.S. approval of once-monthly Boniva is significant because it offers postmenopausal osteoporosis patients a new treatment option that is effective and easy to take. Developed in response to patient need, once-monthly Boniva was approved based on a supplemental new drug application. Once-monthly oral Boniva is not currently approved for use outside of the U.S., although it is undergoing regulatory review in markets across the world, including Europe, where it will be marketed under the trademark Bonviva. Boniva 150 mg once-monthly and Boniva 2.5 mg daily are indicated for the treatment and prevention of postmenopausal osteoporosis. Once-monthly Boniva is expected to be available by prescription in U.S. pharmacies in April. Simon Bicknell Company Secretary Roche and GSK Collaboration In December 2001, F. Hoffmann-La Roche Ltd. (Roche), the originator and developer of Boniva, and GSK announced their plans to co-promote Boniva for the treatment and prevention of postmenopausal osteoporosis in all countries except Japan. The Roche and GSK collaboration provides expertise and commitment to bringing new osteoporosis therapies to market as quickly as possible. 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. For company information, visit GSK on the World Wide Web at www.gsk.com. 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 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. All trademarks used or mentioned in this release are legally protected. Further information: About osteoporosis: www.health-kiosk.ch/start_osteo.htm About Roche: www.roche.com GSK Inquiries: US Media inquiries: Nancy Pekarek (215) 751 7709 Mary Anne Rhyne (919) 483 2319 Patty Seif (215) 751 7709 UK Media inquiries: Phil Thomson 020 8047 5502 Chris Hunter-Ward 020 8047 5502 David Mawdsley 020 8047 5502 Alice Hunt 020 8047 5502 US Analyst/Investor inquiries: Frank Murdolo (215) 751 7002 Tom Curry (215) 751 5419 European Analyst/Investor Duncan Learmouth 020 8047 5540 inquiries: Anita Kidgell 020 8047 5542 This information is provided by RNS The company news service from the London Stock Exchange

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