Investor Update
Basel, 20 November 2006 1,2 3 4 5
NeoRecormon
receives positive opinion in Europe for convenient once weekly treatment of anaemia in cancer patients
with solid tumours
Roche announced today that it has received a
positive recommendation from the European Committee for Medicinal Products for Human Use (CHMP) for
a convenient once weekly subcutaneous dose of its anti-anaemia agent NeoRecormon 30,000
IU in solid cancers. This represents an important amendment as cancer patients on chemotherapy currently
are recommended to receive NeoRecormon three times per week according to the label.
The
NeoRecormon 30,000 IU once weekly regimen will allow physicians and patients to benefit from a simple
dosing schedule which helps to provide optimal care without adding to the burden of cancer treatment.
Final
marketing approval is still to be awaited from the European Commission. The opinion is based on a submission
dossier which included data from the BRAVE (BReast cancer - Anaemia and the Value of Erythropoietin)
study, which was conducted in women with metastatic breast cancer receiving chemotherapy.
About
NeoRecormon
NeoRecormon (epoetin beta) has been prescribed for over 16 years for
the treatment of anaemia in patients with chronic kidney disease and cancer. Treating anaemia increases
red blood cell numbers and oxygen levels allowing the body to function effectively, which improves patients’
quality of life and may reduce morbidity and mortality. NeoRecormon is one of Roche’s leading biotechnology
achievements and market leader in the countries in which it is sold. More than 1 million patient years
of experience have been gained with the product around the world and this widespread use has confirmed
both the benefits NeoRecormon brings to patients and established its well defined safety record. Physicians
can choose to prescribe NeoRecormon via intravenous or convenient subcutaneous routes of administration.
About Anaemia
Anaemia affects
up to 95% of cancer patients receiving chemotherapy.
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 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’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. In 2005 sales by the Pharmaceuticals Division totalled 27.3 billion Swiss
francs, and the Diagnostics Division posted sales of 8.2 billion Swiss francs. Roche employs roughly
70,000 people in 150 countries 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 (www.roche.com).
All
trademarks used or mentioned in this release are protected by law.
References:
1
Coiffier B at al. EHA Abstract 2004
2 M. Marangolo et al. Journal of Clinical
Oncology, 2005 ASCO Annual Meeting Proceedings. Vol 23, No. 16S, Part I of II (June 1 Supplement), 2005:
8141.
3 Groopman & Itri. Natl Cancer Inst 1999;91:1616–34
4
Ludwig H. Future Oncol. 2 (1): 21-38 (2006).
5 Ludwig H et al. Eur J Cancer
2004; 40: 2293-2306.