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{\pard\sa900\fs50\f0\i Media Release\par}
{\pard\f0\li0\ri0\sa360\sl360\fs22 Basel, 9 January 2006\line \line {\b FDA 
approves first 
quarterly I.V. injection for postmenopausal osteoporosis in US} \line \line New 
injection brings benefits 
of Boniva to more women\line \line Roche and GlaxoSmithKline (GSK) announce that 
the U.S. Food and Drug Administration (FDA) has approved a new, quarterly intravenous (I.V.) injection 
of the potent and highly effective osteoporosis drug Boniva (ibandronic acid). This is the first ever 
I.V. injection for the treatment of postmenopausal osteoporosis to be approved by the FDA.\line \line Boniva 
(known as Bonviva outside the U.S.), is already approved as an effective and well-tolerated{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 1\par}}  
once-monthly 
tablet in 33 countries. However, for some women with postmenopausal osteoporosis, oral bisphosphonates 
are not suitable. These women may be unable to take oral bisphosphonate therapy due to another medical 
condition or because they can not stay upright for the required length of time.* For these women, Boniva 
Injection offers a way to gain the proven bone strengthening benefits of bisphosphonate therapy.\line \line William 
M. Burns, CEO Division Roche Pharma commented: \u8220?The U.S. approval of quarterly Boniva Injection represents 
an important new opportunity to bring the bone-strengthening benefits of bisphosphonate therapy to more 
women. Boniva will now be available as two innovative treatment options that may help patients to stay 
on therapy.\u8221? \line \line Gorana Dasic, the US Ibandronate Medical Director at GSK 
said: \u8220?Boniva Injection is the first IV bisphosphonate to be approved for osteoporosis treatment anywhere 
in the world. It was developed in response to the needs of a specific group of patients and supports 
our vision to bring bisphosphonate treatment options to more postmenopausal women.\u8221?\line \line Boniva 
Injection is presented as a pre-filled syringe and is administered once every three months by a healthcare 
professional as a 15 - 30 second injection.\line \line The FDA approval of Boniva 
Injection was based on one year results from the two year DIVA (Dosing IntraVenous Administration) study.{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 2\par}}  
DIVA investigated the efficacy, safety and tolerability of Boniva Injection in comparison to the once-daily 
oral formulation of Boniva and found it to be highly effective and well-tolerated.{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 2,3\par}}  
Previous studies 
have shown that once-daily oral ibandronate reduced the risk of vertebral fracture in women with postmenopausal 
osteoporosis by 62% when taken over three years.{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 4\par}} \line \line The 
Marketing Authorisation 
Application (MAA) for Bonviva Injection was submitted to the European Medicines Agency (EMEA) in April 
2005. \line \line {\b About DIVA} \line DIVA (Dosing IntraVenous 
Administration) 
is a multinational, randomised, double-blind, active control multicentre study in more than 1,300 women 
with postmenopausal osteoporosis aged between 55 and 80 years of age. DIVA compares the efficacy, safety, 
and tolerability of the approved once-daily oral ibandronate 2.5mg regimen with two novel I.V. regimes: 
2mg every two months and 3mg every three months, with lumbar spine bone mineral density at one year 
as the primary endpoint. \line \line \u8226? One Year Results{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 2\par}} \line The 
FDA 
approval of Boniva Injection was based on one year results from the DIVA study.{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 2\par}}  
The results showed 
that the average increase in lumbar spine BMD at one year in patients treated with Boniva Injection 
(3 mg once every three months) was statistically superior to that in patients treated with the daily 
oral tablets (4.5 percent vs. 3.5 percent for the two treatments, respectively, p < 0.001). The study 
also showed that patients treated with Boniva Injection had consistently higher BMD increases in the 
total hip and other skeletal sites (femoral neck and trochanter) than patients treated with oral daily 
Boniva.{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 2\par}} \line \line \u8226? 
Two Year Results{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 3\par}} \line The two-year 
findings from 
the DIVA study were presented at the 2005 Annual Scientific Meeting of the American College of Rheumatology, 
November 12-17 2005.{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 3\par}}  For patients who 
received the 3mg ibandronate every 3 months dosing regimen:\line \line \u8226? 
BMD at the lumbar spine increased more in the I.V. dosing group than in the daily oral dosing group 
(6.3 percent vs. 4.8 percent).\line \u8226? Substantial increases in bone density at the hip (a 
significant non-vertebral site) were also observed, and were also greater in the I.V. group than in 
the oral daily regimen (3.1 percent vs. 2.2 percent).\line \u8226? Clinically relevant decreases 
in bone breakdown (measured by the biochemical marker of bone resorption, serum CTX) were observed in 
all treatment groups.\line \line The I.V. regimen was well tolerated.{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 2\par}}  
The most 
common side effects for I.V. ibandronate reported in a one-year study comparing Boniva Injection and 
Boniva Tablets 2.5 mg daily were arthralgia, back pain, influenza / influenza-like symptoms, hypertension, 
abdominal pain and nasopharyngitis.{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 2\par}}  In 
some patients, acute phase reaction-like events have been reported, 
usually only after the first injection. In most cases, no specific treatment was required and symptoms 
subsided in 24-48 hours. Boniva Injection should not be administered to patients with severe renal impairment.{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 2\par}} \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 Boniva for the treatment and prevention of postmenopausal 
osteoporosis in a number of major markets, excluding Japan. The Roche/GSK collaboration provides expertise 
and commitment to bringing new osteoporosis therapies to market as quickly as possible. \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. 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. \u160?Additional information 
about the Roche Group is available on the Internet (www.roche.com (http://www.roche.com)).\line \line {\b About 
GSK} \line GSK, one of the world\u8217?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. \line \line \line {\pard\f0\li0\ri0\sa360\sl360\fs18 *Oral bisphosphonates 
are taken according 
to a very strict treatment regime which involves remaining upright and not eating, drinking (except 
water) or taking other medications for a period of time before and after the therapy has been taken.\par}\line \line {\pard\f0\li0\ri0\sa360\sl360\fs18 All 
trademarks used or mentioned in this release are legally protected.\par}\line \line {\b Further 
information:} \line - Roche Healthkiosk, Osteoporosis (http://www.health-kiosk.ch/start_osteo.htm)\line - 
About GSK (http://www.gsk.com)\line \line \line {\pard\f0\li0\ri0\sa360\sl360\fs18 {\b References} \line 1. 
Cooper C, Delmas PD, Felsenberg 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 Rheumotology, Vienna, Austria 8-11 June 2005.\line 2. BONIVA (ibandronate 
sodium) INJECTION [prescribing information] Roche Laboratories Inc., Nutley, NJ; 2006.\line 3. 
Emkey R, Zaidi M, Lewiecki EM, Burdesk A, Mairon N et al. Two-year efficacy and tolerability of intermittent 
intravenous ibandronate injections in postmenopausal osteoporosis: the DIVA study. Abstract presented 
at the Annual Meeting of the American College of Rheumatology, 12-17 November 2005, San Diego, USA.\line 4. 
Chesnut C, Skag A, Christiansen C, Recker R, Stakkestad J et al. Effects of Oral Ibandronate Administered 
Daily or Intermittently on Fracture Risk in Postmenopausal Osteoporosis. Journal of Bone & Mineral 
Research 2004; 10 (8): 1421-1429\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}
}