2007-06-02

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


Chicago, Illinois (ots/PRNewswire) -

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

Bondronat(R) (ibandronic acid) has been shown to prevent bone losscaused by anastrozole in post-menopausal women given adjuvant therapyfor early breast cancer according to results from the ARIBON studypresented at the American Society of Clinical Oncology (ASCO) annualmeeting in Chicago.(1)

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

"These study results are very encouraging as they demonstrate thatBondronat can prevent loss of bone in early breast cancer patientswith low bone density who are given anastrozole," said Dr Jim Lester,lead study investigator, Cancer Research Centre, Weston ParkHospital, Sheffield, UK. "anastrozole is an important therapy againstbreast cancer but we clearly want to avoid reducing bone density andincreasing the risk of fractures and osteoporosis in our at-riskpatients."

The ARIBON study evaluated the use of Bondronat, 150mg orally oncea month, in post-menopausal breast cancer patients taking anastrozolewho 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 renalfunction

Data from an additional study presented at ASCO show thatBondronat 6mg, infused over 15 or 60 minutes, does not deterioraterenal function in women with advanced breast cancer and bonemetastases.(4) Bondronat 6mg administered over 15 minutes every 3-4weeks was well tolerated with a safety profile consistent with the60 minute infusion.(4) These data reinforce previous study resultswhich demonstrate Bondronat's positive safety profile and goodtolerability.(5)

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

Notes to Editors:

Dr Jim Lester, lead investigator of the ARIBON study, was awardedan ASCO Foundation Merit Award for his poster. A select number ofASCO Foundation Merit Awards are given annually to recognizeoutstanding abstracts submitted for consideration for presentation atan ASCO scientific meeting.

About Bondronat(R) (ibandronic acid)

Bondronat was approved by the European Commission for theprevention of skeletal events (pathological fractures, bonecomplications requiring radiotherapy or surgery) in patients withbreast cancer and bone metastases in October 2003. Bondronat has beenshown to be an effective treatment for preventing bone fractures andrelieving bone pain in breast cancer in three randomised trials.Additionally a good renal safety profile, demonstrated in randomisedtrials, means that Bondronat limits the risk of kidney deteriorationor failure that has been associated with other i.v. bisphosphonates.Intravenous Bondronat has a renal safety profile which gave noincreased risk of renal adverse events compared with placebo for upto four years of treatment.

For further information on Roche in Oncology go to:

www.roche.com/pages/downloads/company/pdf/mboncology05e_b.pdf

About anastrozole

anastrozole is an effective aromatase inhibitor which prolongsrelapse-free survival in women with hormone receptor positive earlybreast cancer, and has superior efficacy and tolerability overtamoxifen.(6) anastrozole use, however, is associated with a declinein bone mineral density and increased risk of bone fracture in somewomen.(2),(3) Treatment for 5 years with anastrozole is associatedwith a bone loss of 6% to 7% at the lumbar spine and hiprespectively.(3)

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world'sleading research-focused healthcare groups in the fields ofpharmaceuticals and diagnostics. As the world's biggest biotechcompany and an innovator of products and services for the earlydetection, prevention, diagnosis and treatment of diseases, the Groupcontributes on a broad range of fronts to improving people's healthand quality of life. Roche is the world leader in diagnostics anddrugs for cancer and transplantation, a market leader in virology andactive in other major therapeutic areas such as autoimmune diseases,inflammation, metabolism and central nervous system. In 2006 sales bythe Pharmaceuticals Division totalled 33.3 billion Swiss francs, andthe Diagnostics Division posted sales of 8.7 billion Swiss francs.Roche employs roughly 75,000 worldwide and has R&D agreements andstrategic alliances with numerous partners, including majorityownership interests in Genentech and Chugai. Additional informationabout the Roche Group is available on the Internet at www.roche.com.

All trademarks used or mentioned in this release are protected bylaw.

References:

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

(2). Chien A, Goss P. Aromatase inhibitors and bone health inwomen with breast cancer. Journal of Clinical Oncology. 2006.24;5305-5312.

(3). R. E. Coleman ATAC Trialists' Group. Effect of anastrozole onbone 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. Intravenousibandronate 6mg, infused over 15 or 60 minutes, maintains renalfunction in patients with breast cancer and bone metastases. Posterpresented at the American Society of Clinical Oncology (ASCO) annualmeeting, 1-5 June 2007.

(5). Body JJ, Lichinister M, Tjulandin SA, Coleman RE, BergstromB. Safety comparisons of oral ibandronate and intravenous zoledronicacid in Metastatic breast cancer patients: phase III data. Posterpresented at the European Cancer Conference (ECCO), Paris, November2005

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

ots Originaltext: Roche PharmaceuticalsIm Internet recherchierbar: http://www.presseportal.de

Contact:For further information please contact: Hanne Krog, International Portfolio Business Manager, Bondronat, F. Hoffmann-La Roche Ltd., Phone: +41-(0)616-881-695, Mobile: +41-(0)796-988-376, E-mail: hanne_greta.krog@roche.com

Roche Pharmaceuticals

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

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