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Title: Bisphosphonate Bondronat (Ibandronate) Launched Today, New for Treatment Of Metastatic Bone Disease

"Bisphosphonate Bondronat (Ibandronate) Launched Today, New for Treatment Of Metastatic Bone Disease"

LONDON, ENGLAND -- February 6, 2004 -- Roche today launched Bondronat® (ibandronate), the new bisphosphonate for the treatment of Metastatic Bone Disease, at a meeting of leading European cancer specialists in Prague. Metastatic Bone Disease (MBD) is the spread of cancerous cells from the original tumour to the bone and is usually associated with debilitating bone pain and skeletal-related events. As many as 70% of women with breast cancer have MBD, making MBD the most common form of secondary cancer.1 Bondronat® is a new, third generation bisphosphonate which has been shown to significantly reduce skeletal-related events and provide rapid and sustained pain reductions in patients with MBD. The drug was recently 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. Bondronat® is the only bisphosphonate to be available as both an intravenous and an oral formulation allowing clinicians to use the formulation most suitable for the treatment regimen and lifestyle of their patient. The oral formulation has additional convenience benefits for the patient and gives them the opportunity to avoid unnecessary and time consuming hospital visits. In addition, Bondronat® has not been associated with increases in renal toxicity or renal adverse events, and is also recommended for use in patients with severe renal impairment. 2-4 Professor Jean-Jacques Body, from Institut Jules Bordet in Belgium, is confident that the launch of Bondronat® is a significant step forward in the treatment of MBD. " In clinical trials, Bondronat® has demonstrated significant improvements in quality of life for patients with MBD thanks to a marked reduction in pain associated with bone metastases. There are significantly fewer complications of MBD and the safety profile of oral and intravenous Bondronat® appears to be remarkably good, " said Professor Body. Bondronat® (i.v. formulation) has previously been available across Europe for the treatment of hypercalcaemia of malignancy (or elevated calcium levels). Following the approval in the new indication, the approved dosage of Bondronat® for prevention of skeletal metastases in patients with breast cancer and bone metastases is 50 mg once daily administered orally at least 30 minutes before food or 6 mg administered intravenously (infusion over one hour) every 3 to 4 weeks. - Bondronat will be launched in individual countries across Europe over the forthcoming months - All trademarks used or mentioned in this release are legally protected References: 1- Scutellari et al. Metastatic bone disease: Strategies for imaging. Minerva Med. 2003; 94(2):77-90 2- Tripathy D, Body JJ, Diel I, Bergstrom B. Alleviation of bone pain with oral and intravenous ibandronate in women with metastatic breast cancer. Eur J Cancer 2003;1(Suppl. 5):S136. 3- Body JJ, Diel IJ, Lichinitser MR, Kreuser ED, Dornoff W, Gorbunova VA, Budde M, Bergström B and the MF 4265 study group. Intravenous ibandronate reduces the incidence of skeletal complications in patients with breast cancer and bone metastases. Annals of Oncology 2003;14:1399-405. 4- Tripathy D, Body JJ, Diel I, Bergstrom B for the Bondronat Study Group. Oral daily ibandronate: efficacy in reducing skeletal complications in patients with metastatic bone disease from breast cancer. Proc ASCO 2003;22:46 (abstract 185). 5- Diel I, Body JJ, Tripathy D, Bergstrom B for the Bondronat Study Group. Oral daily ibandronate in women with metastatic breast cancer: a pooled safety analysis. Proc ASCO 2003;22:47 (abstract 186). SOURCE: Shire Health London

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