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Neorecormon Gains European Approval for Convenient Once Weekly Treatment of Anaemia in Patients With Solid Cancers

BASEL, SWITZERLAND -- January 10, 2007 -- Roche announced today that it has received European marketing approval for a simple and convenient once weekly subcutaneous injection of NeoRecormon (epoetin beta) 30,000 IU for the treatment of anaemia in patients with solid cancers receiving chemotherapy.

This expansion of the product label means that patients will no longer have the burden of three injections per week and their anaemia can be managed in a more convenient way.

Anaemia affects up to 95% of cancer patients receiving chemotherapy (1). It can develop as a result of the cancer itself or as a consequence of its treatment. For most patients anaemia manifests itself as an extreme and overwhelming fatigue that makes the impact of cancer even more devastating.

NeoRecormon 30,000 IU once weekly is proven to effectively (2) and rapidly (3,4), correct anaemia irrespective of the type of chemotherapy patients receive. It also reduces the need for blood transfusions by at least 50% compared to standard care (5,6), and has been shown to significantly increase the time until patients need a first transfusion (7). Patients treated with NeoRecormon often experience an improvement in their quality of life (8) and an increase in their daily energy levels. (6,9)

Key supportive data for the new label came from the BRAVE (BReast cancer - Anaemia and the Value of Erythropoietin) study, which was conducted in women with metastatic breast cancer receiving chemotherapy (5,7,10) and the NAUTICA study conducted in patients with a wide range of cancer types also receiving chemotherapy. (3)

About NeoRecormon
NeoRecormon is prescribed for the treatment of symptomatic anaemia in patients with cancer. Treating anaemia increases red blood cell (haemoglobin) numbers and oxygen levels allowing the body to function effectively, which improves patients' quality of life and reduces morbidity.

NeoRecormon is one of Roche's leading biotechnology achievements and market leader in the countries in which it is sold.

With the label expansion announced today NeoRecormon 30,000 IU once weekly is now indicated for the treatment of symptomatic anaemia in adult patients with solid and lymphoid cancers receiving any form of chemotherapy. Treatment with NeoRecormon is initiated when patients' haemoglobin level is 11 g/dl or below and given to maintain a haemoglobin level of up to 13g/dl.

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REFERENCES:
(1) Groopman & Itri. Natl Cancer Inst 1999;91:1616-34.
(2) Leonard et al. Ann Oncol 2004; 15 (Suppl 3):iii 50 Abstract 188P.
(3) Spaëth et al. Ann Oncol 2006; 17 (Suppl 9): ix294 Abstract 1020P.
(4) Boogaerts et al. Anticancer Res. 2006; 26:479-484.
(5) Marangolo et al. Eur J Cancer Suppl 2005; 3: 388 Abstract 1347.
(6) Ordónez et al. Lung Cancer 2005; 49(Suppl 2): S339 Abstract P-836.
(7) Aapro et al. 29th Annual San Antonio Breast Cancer Symposium 2006; Poster 6095.
(8) Boogaerts et al. Br J Cancer 2003; 88: 988-995.
(9) de Castro et al. Cancer Chemother Pharmacol 2006; Jul 28 (Epub ahead of print).
(10) Marangolo et al. Journal of Clinical Oncology 2005;23: 16S, Part I of II: 8141.


SOURCE: Roche

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