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{\pard\sa900\fs50\f0\i Media Release\par}
{\pard\f0\li0\ri0\sa360\sl360\fs22 Basel, 27 June 2005\line \line {\b Bonviva, 
the first once-monthly oral tablet for osteoporosis, receives positive opinion in Europe} \line \line Roche 
and GlaxoSmithKline (GSK) announced today that Bonviva (ibandronic acid), the first and only once-monthly 
tablet for the effective treatment of postmenopausal osteoporosis, has received a positive opinion from 
the Committee for Medicinal Products for Human Use (CHMP). \line \line With once-monthly 
Bonviva, a potent and highly effective bisphosphonate,{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 1\par}}  
patients will only have to take 12 tablets a year versus 52 required with current weekly bisphosphonate 
treatments. This is particularly important as almost 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 provide over time{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 3,4\par}}  
Data show that less frequent dosing has a positive impact on how long a patient continues to take a 
medication.2 On approval, Bonviva will be the first ever oral treatment administered as one tablet once 
a month for any disease. \line \line William M. Burns, CEO Division Roche Pharma 
said, \u8220?Bonviva was developed in response to a clear patient need. When approved in Europe, once-monthly 
Bonviva will offer an effective and more convenient regimen which could help women to stay on therapy 
and get the bone protection they need.\u8221?\line \line {\b Adherence to current 
treatments 
sub-optimal} \line Other oral bisphosphonates, the most frequently prescribed medication 
for 
osteoporosis, are available only in daily and weekly dosage forms. Whilst more patients have been shown 
to stay on weekly treatment rather than daily treatment, it was shown that over 50% of patients quit 
taking their medication after one year.{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 5,6,7\par}}  
\line \line {\b Positive 
opinion based on landmark MOBILE data} \line The CHMP positive opinion was based on the 
results 
from MOBILE (Monthly Oral iBandronate In LadiEs), a randomised, double-blind, multinational, non-inferiority 
trial in 1,609 women with postmenopausal osteoporosis. The MOBILE study showed that the monthly dose 
was at least as effective as the daily dose. In addition, the monthly dose resulted in even larger increases 
in Bone Mineral Density (BMD), at lumbar spine and all hip sites, when compared with the daily dose, 
and was statistically superior to the daily dose at all these sites after two years.{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 1\par}}  
\line \line 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 About 
MOBILE} \line MOBILE (Monthly Oral iBandronate In LadiEs) is a two-year, randomized, double-blind 
trial in 1609 women with postmenopausal osteoporosis 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), previously approved by the FDA and European 
Commission. The primary endpoint was at 1 year. One year results from MOBILE were presented in 2004 
at the 26th Annual Meeting of the American Society for Bone Mineral Research, Seattle, USA{\pard\f0\li0\ri0\sa360\sl360\fs18 {\super 8,9,10,11} \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 11,000 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? Bonviva, indicated in Europe as 
a daily formulation for the treatment and prevention of osteoporosis in postmenopausal women, reduces 
bone turnover, increases bone mineral density and reduces the incidence of vertebral fractures.\line \u8226? 
The U.S. Food and Drug Administration gave approval for once-monthly Boniva in March 2005. Boniva has 
been available in the US since late April 2005. \line \u8226? Bonviva is the only bisphosphonate 
that has demonstrated a reduction in vertebral fracture risk using a drug-free interval of more than 
one week.{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 12\par}} \line \u8226? Studies specifically 
designed to demonstrate reductions in non-vertebral 
or hip fractures have not been conducted with Bonviva.\line \u8226? Bonviva, like other orally administered 
bisphosphonates, may cause upper gastrointestinal disorders such as dysphagia, esophagitis and esophageal 
or gastric ulcer.\line \line {\b About post menopausal osteoporosis } \line Bone 
is constantly being rebuilt and goes through a balanced process of bone break-down and new bone formation. 
After menopause, this balance is disrupted and women loose bone faster than it is rebuilt. This imbalance 
can be easily measured by simple blood or urine tests. After years of bone loss, bones become brittle 
and more likely to break. The goal of osteoporosis treatment is to restore the bone balance hence increasing 
bone mass and consequently decreasing the risk of osteoporotic fractures. \line \line \u8226? 
Osteoporosis affects an estimated 75 million people in Europe, USA and Japan.{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 13\par}} \line \u8226? 
1/3 
of women over 50 will experience osteoporotic fractures.{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 13\par}} \line \u8226? 
Osteoporosis is a common 
and chronic condition.{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 13\par}} \line \u8226? 
Like many chronic conditions, over half of all patients prescribed 
daily or weekly osteoporosis treatment stop taking their medicine within 12 months.{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 2,6,7\par}}  
\line \u8226? 
This insufficient adherence to treatment can result in increased risk of further fractures{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 6,7,14\par}}  
\line \u8226? 
Taking medication less often can assist patients to stay on their therapy.{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 5,7\par}} \line \u8226? 
The 
cost to healthcare systems worldwide as a result of osteoporotic fractures is estimated to be in the 
billions of dollars each year.{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 13\par}} \line \u8226? 
The prevalence of osteoporosis is growing, especially 
as the number of postmenopausal women in the population continues to rise.{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 13\par}} \line \u8226? 
An estimated 
52 million women aged fifty plus are expected to be affected by osteoporosis and osteopenia by 2010 
and 61 million are expected to be affected by 2020.{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 13\par}} \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 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. 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. 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 - GSK website (http://www.gsk.com)\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. Caro JJ, Ishak KJ, 
Huybrechts KF, et al. The impact of compliance with osteoporosis therapy on fracture rates in actual 
practice. Osteoporos Int 2004.\line 4. 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 5. 
Cramer JA, Amonkar MM, Hebborn A, Suppapanya N. Does dosing regimen impact persistence with bisphosphonate 
therapy among postmenopausal osteoporotic women? J Bone Miner Res 2004;19(Suppl. 1):S448 (Abstract M434).\line 6. 
Data on file, NDC Health Study. (Ref. 161-011), Hoffmann-La Roche Inc., Nutley, NJ. \line 7. 
Ettinger M, Gallagher R, Amonkar M, et al. Medication persistence is improved with less frequent dosing 
of bisphosphonates, but remains inadequate. Arthritis Rheum 2004;15(Suppl):S513(Abstract 1325).\line 8. 
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 9. 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 10. 
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 11. 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 12. 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.\line 13. International Osteoporosis Foundation.\line 14. 
McCombs JS, Thiebaud P, McLaughlin-Miley C, et al. Compliance with drug therapies for the treatment 
and prevention of osteoporosis. Maturitas 2004;48:271-87. \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}
}
