Basel, 22 October 2004

Avastin receives positive opinion in Europe for the treatment of patients with metastatic colorectal cancer

Roche announced today that its innovative cancer drug, Avastin has received a positive recommendation from the European Committee for Medicinal Products for Human Use (CHMP).

The CHMP has recommended that Avastin (bevacizumab) in combination with intravenous 5-fluorouracil/folinic acid or intravenous 5-fluorouracil/folinic acid/irinotecan is indicated for first-line treatment of patients with metastatic carcinoma of the colon or rectum.

The CHMP’s positive recommendation will now be proposed for final marketing approval by the European Commission. The recommendation is based on data from a pivotal Phase III study that showed that patients treated with Avastin plus chemotherapy* lived on average 30% longer than patients receiving chemotherapy alone (20.3 months versus 15.6 months)¹. Also, on average the addition of Avastin increased by 71% the amount of time that patients were without disease progression, compared to patients receiving chemotherapy alone.

“This is very good news for clinicians and patients alike,” said William M Burns, Head of Roche Pharmaceuticals Division. “The CHMP’s positive recommendation represents an important milestone for Avastin, as it recognises the value that Avastin can add to another current chemotherapy treatment regimen, in addition to the regimen used in the pivotal trial. It also confirms the real benefit that it can offer to patients with advanced colorectal cancer.”

Roche, together with Genentech, presently pursues a comprehensive clinical programme investigating the use of Avastin in advanced colorectal cancer with other chemotherapies and also expanding into the adjuvant setting (post operation). As Avastin’s mechanism may be relevant in a number of malignant tumours, Roche and Genentech are also investigating the potential clinical benefit of Avastin in other cancers, including non-small cell lung cancer, pancreatic, breast and renal cell carcinoma. Around 15,000 patients are expected to be enrolled into clinical trials over the next years worldwide.

In 2000, colorectal cancer was the third most commonly reported cancer with 945,000 new cases worldwide.² It is estimated that over 50% of people diagnosed with colorectal cancer will die of the disease.

About Avastin
Avastin is the first treatment that inhibits angiogenesis – the growth of a network of blood vessels that supply nutrients and oxygen to cancerous tissues. Avastin targets a naturally occurring protein called VEGF (Vascular Endothelial Growth Factor), a key mediator of angiogenesis, thus interfering with the blood supply that is essential for the growth of the tumour and its spread throughout the body (metastasis). It also promotes the effective delivery of chemotherapy within the tumour.

Avastin is also being explored with other chemotherapy regimens including Folfox, Xelox, Xeliri and Folfiri and Xeloda monotherapy.

Avastin was approved in February of this year in the US and has recently received full approval in Israel.

Roche in Oncology
Within the last five years the Roche Group including its partners Genentech in the US and Chugai in Japan has become the world’s leading provider of anti-cancer treatments, supportive care products and diagnostics. Its oncology business includes an unprecedented four marketed products with survival benefit in different major tumour indications: Xeloda and Herceptin in advanced stage breast cancer, MabThera in non-Hodgkin’s lymphoma, and Avastin in colorectal carcinoma. In the United States Herceptin, MabThera and Avastin are marketed either by Genentech alone or together with Biogen Idec Inc. (MabThera). Outside of the United States, Roche and its Japanese partner Chugai are responsible for the marketing of these drugs.

The Roche oncology portfolio also includes NeoRecormon (anaemia in various cancer settings), Bondronat (prevention of skeletal events in breast cancer and bone metastases patients, hypercalcaemia of malignancy), Kytril (chemotherapy and radiotherapy-induced nausea and vomiting) and Roferon-A (hairy cell and chronic myeloid leukaemia, Kaposi's sarcoma, malignant melanoma, renal cell carcinoma). CERA is the most recent demonstration of the commitment to anaemia management. The Roche Group’s cancer medicines generated sales of more than 5.6 billion Swiss francs in the first nine months of 2004.

Roche is developing new tests, which will have a significant impact on disease management for cancer patients in the future. With a broad portfolio of tumour markers for prostate, colorectal, liver, ovarian, breast, stomach, pancreas and lung cancer, as well as a range of molecular oncology tests, we will continue to be the leaders in providing cancer focused treatments and diagnostics.

Roche Oncology has four research sites (two in the US, Germany and Japan) and four Headquarter Development sites (two in the US, UK and Switzerland).

About Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. As a supplier of products and services for the 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 number one in the global diagnostics market, the leading supplier of pharmaceuticals for cancer and transplantation and a market leader in virology. In 2003 prescription drug sales by the Pharmaceuticals Division totalled 19.8 billion Swiss francs, while the Diagnostics Division posted sales of 7.4 billion Swiss francs. Roche employs roughly 65,000 people in 150 countries and has alliances and R&D agreements with numerous partners, including majority ownership interests in Genentech and Chugai.

* Bolus 5-FU/Leucovorin/irinotecan (also known as the Saltz regimen)

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

References:
1. Hurwitz, H,  Fehrenbacher, L, Novotny, W, et al. Bevacizumab plus Irinotecan, Fluorouracil, and Leucovorin for Metastatic Colorectal Cancer. New England Journal of Medicine 2004; 350(23): 2335–2342
2. J. Ferlay, F. Bray, P. Pisani and D.M. Parkin. GLOBOCAN 2000: Cancer Incidence, Mortality and Prevalence Worldwide, Version 1.0. IARC CancerBase No. 5. Lyon, IARCPress, 2001


Further information:
- About Cancer: www.health-kiosk.com