New Data Show Bondronat(R) Prevents Bone Loss Caused by anastrozole in Women With Surgically Treated Breast Cancer

New Data Show Bondronat(R) Prevents Bone Loss Caused by anastrozole in Women With Surgically Treated Breast Cancer

June 04, 2007

-- One Year Results From the ARIBON Study Presented at ASCO
2007


    CHICAGO, June 6 /Xinhua-PRNewswire/ -- Bondronat(R)
(ibandronic acid) has been shown to prevent bone loss
caused by anastrozole in post-menopausal women given
adjuvant therapy for early breast cancer according to
results from the ARIBON study presented at the American
Society of Clinical Oncology (ASCO) annual meeting in
Chicago.(1)

    The study also found that Bondronat significantly
increased bone mineral density in the treated women.(1)
Whilst anastrozole is an effective breast cancer treatment,
its use is associated with a decline in bone mineral density
and an increased risk of bone fracture in some
women.(2),(3)

    "These study results are very encouraging as they
demonstrate that Bondronat can prevent loss of bone in
early breast cancer patients with low bone density who are
given anastrozole," said Dr Jim Lester, lead study
investigator, Cancer Research Centre, Weston Park Hospital,
Sheffield, UK.

    "anastrozole is an important therapy against
breast cancer but we clearly want to avoid reducing bone
density and increasing the risk of fractures and
osteoporosis in our at-risk patients."

    The ARIBON study evaluated the use of Bondronat, 150mg
orally once a month, in post-menopausal breast cancer
patients taking anastrozole who were osteopenic (had mild
thinning of bones) or osteoporotic (more severe bone
density loss). After one year, results showed:(1)

    -- Women with osteopenia treated with Bondronat gained
+2.78% and
       +1.35% of bone density at the lumbar spine and hip
       respectively. Patients treated with placebo lost
-2.61% at the
       lumbar spine and -2.34% at the hip. (p<0.001)

    -- Women with osteoporosis gained +5.05% at the lumbar
spine and
       +2.62% at the hip after 1 year

    Bondronat infused over 15 minutes does not deteriorate
renal function

    Data from an additional study presented at ASCO show
that Bondronat 6mg, infused over 15 or 60 minutes, does not
deteriorate renal function in women with advanced breast
cancer and bone metastases.(4) Bondronat 6mg  administered
over 15 minutes every 3-4 weeks was well tolerated with a
safety  profile consistent with the 60 minute infusion.(4)
These data reinforce  previous  study results which
demonstrate Bondronat's positive safety profile  and good
tolerability.(5)

    In March 2007, the European Commission approved the
administration of Bondronat as a 15 minute infusion in
patients with CLcr more than or equal to 50ml/min.
Bondronat is available as both intravenous (i.v.) and oral
formulations. Both formulations are indicated for the
prevention of skeletal  events in patients with breast
cancer and bone metastases.

    Notes to Editors:

    Dr Jim Lester, lead investigator of the ARIBON study,
was awarded an ASCO Foundation Merit Award for his poster.
A select number of ASCO Foundation Merit Awards are given
annually to recognize outstanding abstracts submitted for
consideration for presentation at an ASCO scientific
meeting.

    About Bondronat(R) (ibandronic acid)

    Bondronat was approved by the European Commission for
the prevention of skeletal events (pathological fractures,
bone complications requiring radiotherapy or surgery) in
patients with breast cancer and bone metastases in October
2003. Bondronat has been shown to be an effective treatment
for preventing bone fractures and relieving bone pain in
breast cancer in three randomised trials. Additionally a
good renal safety profile, demonstrated in randomised
trials, means that Bondronat limits the risk of kidney
deterioration or failure that has been associated with
other i.v. bisphosphonates. Intravenous Bondronat has a
renal safety profile which gave no increased risk of renal
adverse events compared with placebo for up to four years
of treatment.

    For further information on Roche in Oncology go to:
http://www.roche.com/pages/downloads/company/pdf/mboncology05e_b.pdf


    About anastrozole

    anastrozole is an effective aromatase inhibitor which
prolongs relapse-free survival in women with hormone
receptor positive early breast cancer, and has superior
efficacy and tolerability over tamoxifen.(6) anastrozole
use, however, is associated with a decline in bone mineral
density and increased risk of bone fracture in some
women.(2),(3) Treatment  for 5 years with anastrozole is
associated with a bone loss of 6% to 7% at  the lumbar
spine and hip respectively.(3)

    About Roche

    Headquartered in Basel, Switzerland, Roche is one of
the world's leading research-focused healthcare groups in
the fields of pharmaceuticals and diagnostics. As the
world's biggest biotech company and an innovator of
products and services for the early detection, prevention,
diagnosis and treatment of diseases, the Group contributes
on a broad range of fronts to improving people's health and
quality of life. Roche is the world leader in diagnostics
and drugs for cancer and transplantation, a market leader
in virology and active in other major therapeutic areas
such as autoimmune diseases, inflammation, metabolism and
central nervous system. In 2006 sales by the
Pharmaceuticals Division totalled 33.3 billion Swiss
francs, and the Diagnostics Division posted sales of 8.7
billion Swiss francs. Roche employs roughly 75,000
worldwide and has R&D agreements and strategic
alliances with numerous partners, including majority
ownership interests in Genentech and Chugai. Additional
information about the Roche Group is available on the
Internet at http://www.roche.com .

    All trademarks used or mentioned in this release are
protected by law.

    References:

    (1). Lester JE, Gutcher SA, Ellis S, et al. Monthly
oral ibandronate (Bondronat(TM)) prevents
anastrozole-induced bone loss during adjuvant treatment for
breast cancer. One year results from the ARIBON study.
Poster presented at the American Society of Clinical
Oncology (ASCO) annual meeting, 1-5 June 2007.

    (2). Chien A, Goss P. Aromatase inhibitors and bone
health in women with breast cancer. Journal of Clinical
Oncology. 2006. 24;5305-5312.

    (3). R. E. Coleman ATAC Trialists' Group. Effect of
anastrozole on bone mineral density: 5-year results from
the `Arimidex', Tamoxifen, Alone or in Combination (ATAC)
trial. Journal of Clinical Oncology, 2006 ASCO Annual
Meeting Proceedings (Post-Meeting Edition). Vol 24, No 18S
(June 20 Supplement), 2006: 511.

    (4). Moos R, Thurlimann B, Caspar C, et al. Intravenous
ibandronate 6mg, infused over 15 or 60 minutes, maintains
renal function in patients with breast cancer and bone
metastases. Poster presented at the American Society of
Clinical Oncology (ASCO) annual meeting, 1-5 June 2007.

    (5). Body JJ, Lichinister M, Tjulandin SA, Coleman RE,
Bergstrom B. Safety comparisons of oral ibandronate and
intravenous zoledronic acid in Metastatic breast cancer
patients: phase III data. Poster presented at the European
Cancer Conference (ECCO), Paris, November 2005

    (6). Howell A, Cuzick J, Baum M, et al. Results of the
ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial
after completion of 5 years' adjuvant treatment for breast
cancer. Lancet. 2005;365(9453):60-2.


    For more information, please contact:

     Hanne Krog
     International Portfolio Business Manager
     Bondronat, F. Hoffmann-La Roche Ltd.
     Tel:    [phone]
     Mobile: [phone]
     Email:  [e-mail]