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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