Basel, 20 September 2004
Bonviva: First once-a-month tablet regimen for the treatment of osteoporosis submitted in Europe
Roche and GlaxoSmithKline plc announced today the submission of a Marketing Authorisation Application to the European authorities for a novel, once-monthly oral formulation of their new bisphosphonate, Bonviva (ibandronate), for the treatment of postmenopausal osteoporosis.
“Bonviva is expected to be the first once-monthly tablet for osteoporosis, potentially enhancing compliance for patients throughout Europe. It offers the efficacy of a bisphosphonate with the simple convenience of just 12 tablets a year," commented William M. Burns, Head of Roche Pharmaceuticals Division. "This follows the filing for the once monthly regimen in the US earlier this year and brings us a step closer to commercialising the first ever monthly oral formulation of any pharmaceutical brand.”
The application is supported by clinical trial data (the MOBILE study), which investigated more convenient oral regimens of Bonviva for the treatment of osteoporosis. Both Bonviva doses studied (100 mg and 150 mg monthly) were at least as effective as the daily regimen in increasing spine Bone Mineral Density (BMD), a commonly used marker of drug efficacy. Preliminary safety evaluation indicates that the monthly oral regimens were well tolerated.
“A dosing regimen of just a single tablet once a month offers patients a new degree of freedom, potentially making it easier for them to take their therapy and stay on it,” observed Andrew Witty, President, Pharma Europe at GSK.
The European Commission approved the once-daily formulation in February 2004, and the companies have been exploring more convenient dosing options before launching the product. A supplemental new drug application (sNDA) for the once-monthly formulation was filed with the U.S. Food and Drug Administration (FDA) in May 2004.
Bonviva, 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 bi-monthly/quarterly intravenous dosage regimens in women with postmenopausal osteoporosis.
Once daily Bonviva is indicated for the treatment and prevention of osteoporosis in postmenopausal women by reduction of elevated bone turnover, increasing bone mineral density and reduction of the incidence of vertebral fractures.
About the Roche/GSK Collaboration
In December 2001, Roche and GSK announced that they would co-develop and co-promote Bonviva 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.
Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-intensive healthcare groups. Its core businesses are pharmaceuticals and diagnostics. As a supplier of innovative 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 is number one in the global diagnostics market, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2003, the Pharmaceuticals Division generated 19.8 billion Swiss francs in prescription drug sales, while the Diagnostics Division posted sales of 7.4 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.
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.
trademarks used or mentioned in this release are legally protected.
Note to editors:
- BMD (bone mineral density), measured by densitometry, gives an accurate and precise measurement of the amount of bone.
- Bonviva, like other bisphosphonates administered orally, may cause upper gastrointestinal disorders such as dysphagia, esophagitis and esophageal or gastric ulcer.
- Bonviva is a trademark of the Roche Group.