29th Mar 2005 07:01
GlaxoSmithKline PLC29 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) todayapproved once-monthly oral Boniva(R) (ibandronate sodium) 150 mg Tablets, thefirst and only once-monthly medicine for the treatment of postmenopausalosteoporosis, GlaxoSmithKline (GSK) announced. Boniva is the first-ever oraltreatment administered as one tablet once a month for any chronic disease. Withonce-monthly Boniva, an effective bisphosphonate, patients would take 12 tabletsa year versus 52 required with current weekly bisphosphonate treatments. TheU.S. approval of once-monthly Boniva is significant because it offerspostmenopausal osteoporosis patients a new treatment option that is effectiveand easy to take. Developed in response to patient need, once-monthly Boniva was approved based ona supplemental new drug application. Once-monthly oral Boniva is not currentlyapproved for use outside of the U.S., although it is undergoing regulatoryreview in markets across the world, including Europe, where it will be marketedunder the trademark Bonviva. Boniva 150 mg once-monthly and Boniva 2.5 mg daily are indicated for thetreatment and prevention of postmenopausal osteoporosis. Once-monthly Boniva isexpected to be available by prescription in U.S. pharmacies in April. Simon BicknellCompany Secretary Roche and GSK Collaboration In December 2001, F. Hoffmann-La Roche Ltd. (Roche), the originatorand developer of Boniva, and GSK announced their plans to co-promote Boniva forthe treatment and prevention of postmenopausal osteoporosis in all countriesexcept Japan. The Roche and GSK collaboration provides expertise and commitmentto bringing new osteoporosis therapies to market as quickly as possible. About GSK GSK, one of the world's leading research-based pharmaceutical and healthcarecompanies, is committed to improving the quality of human life by enablingpeople to do more, feel better and live longer. For company information, visitGSK on the World Wide Web at www.gsk.com. About Roche Headquartered in Basel, Switzerland, Roche is one of the world's leadingresearch-focused healthcare groups in the fields of pharmaceuticals anddiagnostics. As a supplier of innovative products and services for the earlydetection, prevention, diagnosis and treatment of disease, the Group contributeson 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 forcancer and transplantation and a market leader in virology. In 2004 sales by thePharmaceuticals Division totalled 21.7 billion Swiss francs, while theDiagnostics Division posted sales of 7.8 billion Swiss francs. Roche employsroughly 65,000 people in 150 countries and has R&D agreements and strategicalliances with numerous partners, including majority ownership interests inGenentech and Chugai. All trademarks used or mentioned in this release are legally protected. Further information:About osteoporosis: www.health-kiosk.ch/start_osteo.htmAbout 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 5540inquiries: Anita Kidgell 020 8047 5542 This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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