Basel, 29 March 2005

FDA approves once-monthly Boniva for osteoporosis
First ever monthly single tablet for any disease

The U.S. Food and Drug Administration (FDA) approved once-monthly oral Boniva (ibandronate sodium) 150 mg Tablets, the first and only once-a-month medicine for the treatment of postmenopausal osteoporosis, Roche and GlaxoSmithKline (GSK) announced last Friday.

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.

“Boniva is the first and only once-monthly osteoporosis medication that maintains and actually builds bone density,” said Ronald Emkey, M.D., clinical trial investigator and Medical Director of Radiant Research, Reading, PA. “The approval of this medication is significant because it offers patients a new treatment option that is effective and easy to take.”

Why monthly Boniva?
This new treatment option comes in the wake of the Surgeon General’s Report elevating osteoporosis to a major public health threat on par with smoking and obesity.¹ Forty-four million Americans over 50 years of age, are affected by or at risk for osteoporosis, which causes bones to become weak and more likely to break, and can result in severe pain, deformity, disability, hospitalization and even death.² To improve persistence, the Surgeon General’s Report has recommended, among various measures, simplifying and organizing treatment regimens.¹
“Osteoporosis is a serious, widespread and growing public health threat. We welcome any new treatment options such as Boniva that will help patients address this all too prevalent disease,” said Judith Cranford, Executive Director, National Osteoporosis Foundation.

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.

About Boniva

• Daily Boniva (2.5 mg) was approved for the treatment and prevention of osteoporosis based on studies showing that, over three years, it significantly reduced the risk of new vertebral fractures in women with postmenopausal osteoporosis, and increased BMD in postmenopausal women without osteoporosis.
• Once-monthly oral Boniva (150 mg) was approved based on results from MOBILE (Monthly Oral iBandronate In LadiEs), a randomised, double-blind, multinational, non-inferiority trial in 1,602 women with postmenopausal osteoporosis showing that the monthly dose was at least equivalent to the daily dose in increasing BMD after one year at lumbar spine and other skeletal sites.
• Boniva 150 mg once-monthly and Boniva 2.5 mg daily are indicated for the treatment and prevention of postmenopausal osteoporosis. It is a small, film-coated easy to swallow tablet.
• Patients who take Boniva are eligible to sign up for the Boniva Patient Support Program designed to help enhance compliance (taking therapy as directed) and persistence (staying on therapy) with this unique once-monthly regimen.
• For more information go to www.4Boniva.com.

About Post Menopausal Osteoporosis
Bone is constantly being rebuilt and goes through a balanced process of bone break-down and new bone formation. After menopause, this balance is disrupted and women loose bone faster than it is rebuilt. This imbalance can be easily measured by simple blood or urine tests. After years of bone loss, bones become brittle and more likely to break. The goal of osteoporosis treatment is to restore the bone balance hence increasing bone mass and consequently decreasing the risk of osteoporotic fractures.

• Osteoporosis affects an estimated 75 million people in Europe, USA and Japan.³
• 1/3 of women over 50 will experience osteoporotic fractures.³
• Osteoporosis is a common and chronic condition.³
• Like many chronic conditions, over half of all patients prescribed daily or weekly osteoporosis treatment stop taking their medicine within 12 months.^{4, 5}
• This insufficient adherence to treatment can result in increased risk of further fractures.^{6, 7}
• Taking tablets less often can assist patients to stay on their therapy.^4,5
• The cost to healthcare systems worldwide as a result of osteoporotic fractures is estimated to be in the billions of US dollars each year.³
• The prevalence of osteoporosis is growing, especially as the number of postmenopausal women in the population continues to rise.³
• An estimated 52 million women aged fifty plus are expected to be affected by osteoporosis and osteopenia by 2010 and 61 million are expected to be affected by 2020.³

Roche/GSK Collaboration
In December 2001, 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 all countries except Japan. The Roche/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

1 Bone Health and Osteoporosis: A Report of the Surgeon General. Rockville, MD: U.S. Department of Health and Human Services, Office of the Surgeon General; 2004.
2 America's Bone Health: The State of Osteoporosis and Low Bone Mass in Our Nation: The National Osteoporosis Foundation; February 2002.
3 International Osteoporosis Foundation.
4 Cramer JA, Amonkar MM, Hebborn A, Suppapanya N. Does dosing regimen impact persistence with bisphosphonate therapy among postmenopausal osteoporotic women? J Bone Miner Res 2004;19(Suppl. 1):S448(Abstract M434).
5 Ettinger M, Gallagher R, Amonkar M, et al. Medication persistence is improved with less frequent dosing of bisphosphonates, but remains inadequate. Arthritis Rheum 2004;15(Suppl):S513(Abstract 1325).
6 Caro JJ, Ishak KJ, Huybrechts KF, et al. The impact of compliance with osteoporosis therapy on fracture rates in actual practice. Osteoporos Int 2004 (In press).
7 McCombs JS, Thiebaud P, McLaughlin-Miley C, et al. Compliance with drug therapies for the treatment and prevention of osteoporosis. Maturitas 2004;48:271-87.