Investor Update
Basel, 14 January 2005 1 2 3
Innovative
Roche cancer medicine Avastin approved in EU
First treatment of
its kind with proven survival benefit for patients with advanced colorectal cancer
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)
In
2000, colorectal cancer was the third most commonly reported cancer with 945,000 new cases worldwide.
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.
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
All
trademarks used or mentioned in this release are legally protected.
Further information:
- Genentech: www.gene.com
- Cancer: www.health-kiosk.ch