Basel, 20 December 2004

Breakthrough cancer treatment Avastin approved in Switzerland
First approval of innovative anti-angiogenesis medicine in Europe

Roche today announced that the Swiss health authority Swissmedic has approved Avastin (bevacizumab, rhuMAb-VEGF) for the treatment of patients with previously untreated metastatic cancer of the colon or rectum. The Swiss approval lays the foundation for access to the medicine in more than 90 other countries. Roche will start to supply Avastin in Switzerland within the next few weeks and expects reimbursements to come through early next year.

Avastin is now approved for first-line treatment of patients with metastatic cancer of the colon or rectum in combination with the commonly used chemotherapy regimens of intravenous 5-fluorouracil/folinic acid or intravenous 5-fluorouracil/folinic acid/irinotecan.

“We were delighted when Swissmedic granted priority review to Avastin earlier this year, and now that the full marketing approval has been granted we will be working to ensure that Avastin is made available to cancer patients in Switzerland as quickly as possible,” said William M. Burns, Head of Roche’s Pharmaceuticals Division.

“The approval and availability of Avastin offers hope for patients with colorectal cancer, because it represents a major advance in the treatment of this disease. Avastin is the first drug that works by choking off the blood supply that feeds tumours,” said Professor Richard Herrmann, Head of Oncology Department in the University Hospital Basel. “The significant increase in survival for patients provided by the addition of Avastin to a variety of different chemotherapy regimens used in the treatment of colorectal cancer, without the increase in side effects normally associated with chemotherapy, is a breakthrough in the treatment of this disease.”

The approval is based on data from a landmark Phase III study published in the New England Journal of Medicine that showed patients treated with Avastin plus chemotherapy lived significantly longer than patients receiving chemotherapy alone, on average by nearly five months (20.3 months versus 15.6 months).¹ Also, the addition of Avastin increased the amount of time that patients were without disease progression, on average four months, compared to patients receiving chemotherapy alone (10.6 months versus 6.2 months).

In 2000, colorectal cancer was the third most commonly reported cancer with 945,000 new cases worldwide² and 3,700 in Switzerland³ respectively. It is estimated that over 50% of people diagnosed with colorectal cancer will die of the disease.

Roche and Genentech are pursuing 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 cancer, renal cell carcinoma and others. Approximately 15,000 patients are expected to be enrolled into clinical trials over the next years worldwide.

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 choking off the blood supply that is essential for the growth of the tumour and its spread throughout the body (metastasis).

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 members Genentech in the United States 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 five products with survival benefit in different major tumour indications: Xeloda and Herceptin in advanced stage breast cancer, MabThera in non-Hodgkin’s lymphoma, Avastin in colorectal carcinoma and Tarceva in non-small cell lung cancer and pancreatic carcinoma.

In the United States Herceptin, MabThera, Avastin and Tarceva are marketed either by Genentech alone or together with its partners Biogen Idec Inc. (MabThera) and OSI (Tarceva). Outside of the United States, Roche and its Japanese partner Chugai are responsible for the marketing of these medicines.
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 Roche’s 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.

In addition to the medicines, Roche is developing new diagnostic tests that 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, Roche will continue to be the leader in providing cancer-focused treatments and diagnostics.

Roche has four research sites (two in the United States and one each in Germany and Japan) and five development sites (two in the United States and one each in UK, Australia and Switzerland).

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


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Further information:
- www.gene.com
- www.health-kiosk.ch


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. Ferlay, J, Bray,F, Pisani, P, and Parkin, D.M. GLOBOCAN 2000: Cancer Incidence, Mortality and Prevalence Worldwide, Version 1.0. IARC CancerBase No. 5. Lyon, IARCPress, 2001
^3. Vereinigung Schweizerischer Krebsregister, 2003