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{\pard\sa900\fs50\f0\i Media Release\par}
Basel, 19 September 2005\line \line {\b Once-monthly oral 
Bonviva approved for postmenopausal osteoporosis in Europe} \line \line Highly 
effective single monthly tablet a first for any chronic disease\line \line Roche 
and GlaxoSmithKline (GSK) today announced that European Union marketing authorization has been granted 
for Bonviva 150mg for the treatment of postmenopausal osteoporosis. \line Bonviva (ibandronic 
acid) is the first and only once-monthly tablet for the treatment of postmenopausal osteoporosis. This 
announcement follows FDA and Swissmedic approval earlier this year. \line Bonviva, a potent 
and highly effective bisphosphonate{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 1\par}}  is 
the first ever oral treatment administered as one tablet once a month for any disease. This means patients 
will only have to take 12 Bonviva tablets a year versus 52 or 365 required with current weekly or daily 
bisphosphonate treatments. This is particularly important as many patients find osteoporosis therapy 
inconvenient, which may help to explain why up to two-thirds of patients stop taking their osteoporosis 
treatment within a year,{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 2\par}}  foregoing the 
bone building benefits these drugs can only provide over time.{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 3\par}} \line Poor 
adherence has a 
negative effect on treatment outcomes including lower gains in bone mineral density (BMD),{\pard\f0\li0\ri0\sa360\sl360\fs18 {\super 4,5} \par} 
smaller 
decreases in the rate of bone turnover{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 4\par}}  
and a significantly greater risk of fractures{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 .6\par}} \line William 
M. Burns, CEO Division Roche Pharma said: \u8220?We are very pleased about the European Union marketing authorization 
for once-monthly Bonviva. We can now offer women with postmenopausal osteoporosis an effective and more 
convenient regimen which could help them stay on therapy, therefore providing the bone-building benefits 
they need over time\u8221?. \line \line Andrew Witty, President of EU Pharma, GSK said: 
\u8220?GSK welcomes this announcement and is delighted to be able to offer healthcare professionals and patients 
throughout Europe a once monthly treatment option for postmenopausal osteoporosis\u8221?.\line Bonviva, 
a highly effective bisphosphonate, delivered a reduction in the occurrence of new vertebral fractures 
of 62% over three years at a 2.5mg daily dose.{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 7\par}}  
Bonviva is also the only nitrogen-containing bisphosphonate 
that has demonstrated a reduction in vertebral fracture risk using a drug-free interval of more than 
one day.{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 7\par}} \line European Union 
marketing authorization for once monthly oral Bonviva is based 
on 2-year results of the MOBILE (Monthly Oral iBandronate In LadiEs) phase III study in 1,609 women 
with postmenopausal osteoporosis. The study shows the monthly dose was highly effective and well tolerated 
over two years and is actually statistically superior at increasing bone mineral density (BMD) compared 
to the daily dose.{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 1\par}} \line Bonviva 
(known in the US as Boniva) 150mg once-monthly oral is indicated 
for the treatment of postmenopausal osteoporosis in Europe. It is anticipated the UK and Germany will 
be first to launch the once-monthly formulation in the EU. In the US, once-monthly Boniva 150mg is indicated 
for the treatment of osteoporosis in postmenopausal women. In the USA and in Europe, Bonviva is co-promoted 
by GSK.\line \line {\b About MOBILE} \line MOBILE (Monthly 
Oral iBandronate 
In LadiEs) is a two-year, randomized, double-blind trial comparing the efficacy and safety of monthly 
oral doses of ibandronate (100mg on a single day; 100mg as separate 50mg doses on two consecutive days; 
or 150mg on a single day) versus the oral daily regimen (2.5mg), approved by the FDA and European Commission, 
in 1,609 women with postmenopausal osteoporosis. The primary endpoint was analysed at 1 year. One year 
results from MOBILE were recently published in the Journal of Bone and Mineral Research{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 4\par}}  
and full two 
year results were presented at the Annual European Congress of Rheumatology, Vienna, Austria 8-11 June 
2005.{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 1\par}} \line \line {\b About 
Bonviva} \line \u8226? Bonviva, a potent bisphosphonate, 
has been studied to date in clinical trials involving over 12,000 patients\line \u8226? The ongoing 
clinical development programme is evaluating monthly oral and bi-monthly/quarterly intravenous dosage 
regimens in women with postmenopausal osteoporosis\line \u8226? 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\line \u8226? 
Studies specifically designed to demonstrate reductions in non-vertebral or femoral neck fractures have 
not been conducted with Bonviva\line \u8226? Bonviva, like other bisphosphonates administered orally, 
may cause upper gastrointestinal disorders such as dysphagia, oesophagitis and oesophageal or gastric 
ulcer\line \u8226? Bonviva (known in the US as Boniva), was approved by the US Food and Drug Administration 
in March 2005. In the US, Boniva 150mg is indicated for the treatment of osteoporosis in postmenopausal 
women.\line \line {\b Roche/GSK collaboration} \line In 
December 2001, F. Hoffmann-La 
Roche (Roche) and GlaxoSmithKline (GSK) announced their plans to 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 bringing new osteoporosis therapies to market as 
quickly as possible.\line \line {\b About GSK} \line 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 Internet at www.gsk.com (http://www.gsk.com).\line \line {\b About 
Roche} \line Headquartered 
in Basel, Switzerland, Roche is one of the world\u8217?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 \line Group contributes 
on a broad range of fronts to improving people\u8217?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. For further information: www.roche.com (http://www.roche.com).\line \line {\pard\f0\li0\ri0\sa360\sl360\fs18 All 
trademarks used or mentioned in this release are legally protected.\par}\line \line \line {\b Additional 
information} \line - About postmenopausal osteoporosis ( http://www.roche.com/mbosteop05e.pdf)\line - 
Roche Health-Kiosk, Osteoporosis (http://www.health-kiosk.ch/start_osteo.htm)\line \line \line {\pard\f0\li0\ri0\sa360\sl360\fs18 References:\line 1. 
Cooper C, Delmas PD, Felsenburg D, Hughes C, Mairon N et al. Two-year efficacy and tolerability of once 
monthly oral ibandronate in postmenopausal osteoporosis: the MOBILE study. Abstract presented at the 
Annual European Congress of Rheumatology, Vienna, Austria 8-11June 2005.\line 2. DIN-LINK 
data, Compufile Ltd, January 2004. NB. Patients are excluded from the analysis at the point where they 
stop taking therapy altogether or have failed to comply fully.\line 3. Sebaldt R, Shane L, 
Pham B, et al. Impact of non-compliance and non-persistence with daily bisphosphonates on longer-term 
effectiveness outcomes in patients with osteoporosis treated in tertiary specialist care. J Bone Miner 
Res 2004;19(Suppl. 1): (Abstract M423).\line 4. Eastell R et al. Calcif Tissue Int 2003;72:408 
(Abstract P-297)\line 5. Finigan J et al. Osteoporos Int 2001;12:S48\u8211?S49 (Abstract P110)\line 6. 
Caro J et al. Value Health 2002;5:127\line 7. Chestnut et al. Effects of Oral Ibandronate 
Administered Daily or Intermittently on Fracture Risk in Postmenopausal Osteoporosis. Journal of Bone 
& Mineral Research, vol. 10: 8, 2004.\par}
{\pard \par}
{\pard\sb180\f1\fs22 {\b F. Hoffmann-La Roche Ltd}\line 4070 Basel\line Switzerland \par}
{\pard\sb180\f1\fs22 Corporate Communications\line Roche Group Media Relations \par}
{\pard\sb180\f1\fs22 Tel. +41 61 688 88 88\line Fax +41 61 688 27 75\line www.roche.com \par}
}
