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Roche Pharmaceuticals

Innovative Roche cancer medicine Avastin approved in EU

Basel, Switzerland (ots/PRNewswire)

- 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) (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: www.roche.com
About Genentech: www.gene.com
About cancer: 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

Contact:

Media Relations Contacts: Phone: +41-61-688-88-88/e-mail:
basel.mediaoffice@roche.com, Baschi Dürr, Alexander Klauser, Daniel
Piller (Head Roche Group Media Office), Katja Prowald (Head Science
Communications), Martina Rupp

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