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Assunto: Innovative Roche Cancer Medicine Avastin Approved in EU

Innovative Roche Cancer Medicine Avastin Approved in EU

BN003644 14 de janeiro de 2005 09:08 HORALOCAL

CIÊNCIA

Innovative Roche Cancer Medicine Avastin Approved in EU

First Treatment of Its Kind With Proven Survival Benefit for Patients With Advanced Colorectal Cancer

BASEL, Switzerland, Jan. 14 /PRNewswire/ -- Roche today announced that the European Commission has approved Avastin (bevacizumab, rhuMAb-VEGF), the new innovative anti-angiogenesis drug, for the treatment of patients with previously untreated metastatic colorectal cancer. Roche will now make Avastin available across Europe within the next few weeks and expects it to be accessible to physicians and patients early in the year. Avastin is now approved for the first-line treatment of patients with metastatic carcinoma of the colon or rectum in combination with the chemotherapy regimens of intravenous 5-fluorouracil/folinic acid or intravenous 5-fluorouracil/folinic acid/irinotecan. "Today's full marketing approval represents a significant milestone for clinicians and patients across Europe engaged in the fight against cancer," said William M. Burns, CEO of Roche's Pharmaceuticals Division. "We will now work to ensure that this breakthrough treatment is widely available throughout Europe as quickly as possible." "Avastin represents the culmination of decades of research looking into the process of angiogenesis," said Professor Eric Van Cutsem, University Hospital Gasthuisberg, Leuven, Belgium. "It is the first drug that works by choking off the blood supply that feeds tumours. Throughout several well designed clinical trials we have seen a meaningful increase in life expectancy when Avastin is combined with different chemotherapy regimens used in the treatment of advanced colorectal cancer." The European Commission's approval was based on data from a landmark Phase III study published in The New England Journal of Medicine in June 2004 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 worldwide.(2) It is estimated that over 50% of people diagnosed with colorectal cancer will die of the disease. In the European Union colorectal cancer is the second most common cause of death from any cancer in men.(3) 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, breast cancer and renal cell carcinoma. 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 2004 in the US and has recently received full approval in Switzerland and 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 oncology research sites (two in the United States and one each in Germany and Japan) and five oncology 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.

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

Further information: About Roche: http://www.roche.com About Genentech: http://www.gene.com About cancer: http://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. Boyle, P, Langman, JS. ABC of colorectal cancer. Epidemiology. BMJ 2000; 321: 805-808

SOURCE Roche 01/14/2005 CONTACT: Baschi Durr, or Alexander Klauser, or Daniel Piller, Head Roche Group Media Office, or Katja Prowald, Head Science Communications, or Martina Rupp, all of Roche, +41-61-688-88-88, or basel.mediaoffice@roche.com Web site: http://www.roche.com http://www.gene.com http://www.health-kiosk.ch

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