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{\pard\sa900\fs50\f0\i Media Release\par}
{\pard\f0\li0\ri0\sa360\sl360\fs22 Basel, 8 September 2005\line \line {\b Once-monthly 
oral Bonviva approved for postmenopausal osteoporosis in Switzerland \line } First and 
only single monthly tablet for any chronic disease\line \line Roche and Glaxo SmithKline 
today announced that the Swiss health authority Swissmedic has approved Bonviva 150mg (ibandronic acid) 
for the treatment of postmenopausal osteoporosis. Swiss approval lays the foundation for access to the 
medicine in more than 70 other countries.\line \line Bonviva is the first and only 
once-monthly tablet for the treatment of postmenopausal osteoporosis. This announcement marks the first 
approval of Bonviva outside the United States of America. Bonviva received a positive opinion from the 
Committee for Medicinal Products for Human Use (CHMP) last June and it is expected that European Union 
marketing authorization will follow later this year. \line \line Bonviva, a potent 
and highly effective bisphosphonate,{\super 1}  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 required with current weekly bisphosphonate treatments. This is particularly important 
as almost two-thirds of patients on current treatment stop taking their osteoporosis treatment within 
a year,{\super 2}  foregoing the bone building benefits these drugs can provide over 
time.{\super 3} \line \line William M. Burns, CEO Division Roche 
Pharma said, "The approval of once-monthly Bonviva is another example of Roche\u8217?s commitment to 
the development 
of medicines that more closely meet the need of patients. This announcement is significant because we 
can now offer women with postmenopausal osteoporosis in Switzerland and around the world an effective 
and more convenient treatment option. This may help them stay on therapy and get the bone-building benefits 
they need over time." \line \line The Swiss approval for treatment of osteoporosis 
in postmenopausal women in order to reduce vertebral fracture is based on 1-year results of the MOBILE 
(Monthly Oral iBandronate In LadiEs) phase III study in 1,609 women with postmenopausal osteoporosis. 
\line The study shows the monthly dose was highly effective and well tolerated over one year 
and actually is superior at increasing bone mineral density (BMD) compared to the daily dose,{\super 1}  
which 
provides a reduction in the occurrence of new vertebral fractures of 62% over three years {\super 4} . 
Bonviva 
is the only bisphoshonate that has demonstrated a reduction in vertebral fracture risk using a drug-free 
interval of more than one day.{\super 4}  \line \line Other oral 
bisphosphonates, the most 
frequently prescribed medication for osteoporosis, are available only in daily and weekly dosage forms. 
The transition of the market from daily to weekly dosing has resulted in better adherence to bisphosphonates, 
but it remains suboptimal{\super 5} . Poor adherence has a negative effect on treatment 
outcomes including lower 
gains in BMD{\super 6,7}  , smaller decreases in the rate of bone turnover{\super 6}  
and a significantly greater risk of 
fractures.{\super 8} \line \line Bonviva (known in the US as Boniva) 
was approved by the US 
Food and Drug Administration in March 2005. 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 presented at the 26th Annual Meeting of the American 
Society for Bone Mineral Research, Seattle, USA {\super 9,10,11,12}  and full two year 
results were presented 
at the Annual European Congress of Rheumatology, Vienna, Austria 8-11 June 2005.{\super 1}  
\line \line {\b About 
Bonviva} \par}{\pard\f0\li440\ri0\sl360\fs22 - Bonviva, a potent bisphosphonate, has 
been studied to date in clinical 
trials involving over 9,000 patients\par}{\pard\f0\li440\ri0\sl360\fs22 - The ongoing clinical development 
programme is 
evaluating monthly oral and bi-monthly/quarterly intravenous dosage regimens in women with postmenopausal 
osteoporosis\par}{\pard\f0\li440\ri0\sl360\fs22 - 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\par}{\pard\f0\li440\ri0\sl360\fs22 - Studies specifically 
designed to 
demonstrate reductions in non-vertebral or femoral neck fractures have not been conducted with Bonviva\par}{\pard\f0\li440\ri0\sl360\fs22 - Bonviva, 
like other bisphosphonates administered orally, may cause upper gastrointestinal disorders 
such as dysphagia, esophagitis and esophageal or gastric ulcer\par}\line {\pard\f0\li0\ri0\sa360\sl360\fs22 {\b Roche/GSK 
Collaboration} \line 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. \line \line {\b 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 World Wide Web at www.gsk.com (http://www.gsk.com).\line \line {\b 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 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 {\pard\f0\li0\ri0\sa360\sl360\fs18 References:\line 1. 
Cooper C, Delmas PD, Felsenburg D, Hughes C, Mairon N {\i et al} . Two-year efficacy 
and tolerability of once 
monthly oral ibandronate in postmenopausal osteoporosis: the MOBILE study. Abstract presented at the 
{\i 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. Chestnut {\i 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.\line 5. Data on file, NDC Health Study. (Ref. 161-011), 
Hoffmann-La Roche Inc., Nutley, NJ. \line 6. Eastell R et al. Calcif Tissue Int 2003;72:408 
(Abstract P-297)\line 7. Finigan J et al. Osteoporos Int 2001;12:S48-S49 (Abstract P110)\line 8. 
Caro J et al. Value Health 2002;5:127\line 9. Miller PD, Drezner MK, Delmas PD, Stakkestad 
JA, Hughes C, Bonvoisin B, Reginster J-Y. Monthly oral ibandronate is at least as effective as oral 
daily ibandronate in postmenopausal osteoporosis: 1-year results from MOBILE. Poster F408, presented 
at: 26th Annual Meeting of the American Society for Bone Mineral Research, October 1-5, 2004, Seattle, 
WA.\line 10. Emkey R, Felsenberg D, Stepan JJ, Hughes C, Dumont E, Van der Auwera P, Recker 
RR. Once monthly dosing increases the proportion of patients who respond to oral ibandronate: 1-year 
results from MOBILE. Poster M432, presented at: 26th Annual Meeting of the American Society for Bone 
Mineral Research, October 1-5, 2004, Seattle, WA.\line 11. Recker RR, Kendler DL, Adami S, 
Hughes C, Dumont E, Schimmer RC, Cooper C. Monthly oral ibandronate significantly reduces bone resorption 
in postmenopausal osteoporosis: 1-year results from MOBILE. Poster F406, presented at: 26th Annual Meeting 
of the American Society for Bone Mineral Research, October 1-5, 2004, Seattle, WA.\line 12. 
Lewiecki EM, Miller PD, Lorenc R, Hughes C, Bonvoisin B, McClung MR. Monthly oral ibandronate is well 
tolerated in women with postmenopausal osteoporosis: 1-year results from MOBILE. Poster M429, presented 
at: 26th Annual Meeting of the American Society for Bone Mineral Research, October 1-5, 2004, Seattle, 
WA\line \par}\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}
}