Xeloda Meets Primary Endpoint in Multinational Phase III Advanced Colorectal Cancer Study

Basel, Switzerland (ots/PRNewswire) -

- Roche to Approach World-Wide Regulatory Authorities for a New
File Submission

Roche announced today that a large, international Phase III study
(NO16967) of 627 previously treated patients with advanced colorectal
cancer met its primary endpoint of progression-free survival. Study
results showed that the chemotherapy combination XELOX (oral Xeloda
plus oxaliplatin) is as effective in delaying disease progression as
the chemotherapy combination FOLFOX-4 (infused 5-FU/leucovorin plus
oxaliplatin).

"This data endorses previous findings that oral Xeloda in
combination with oxaliplatin may provide a new treatment choice for
colorectal cancer patients" said Eduard Holdener, Head of Global
Development at Roche. " These data will be used in the submission to
worldwide regulatory authorities to allow patients with colorectal
cancer the opportunity to have an effective and more convenient
therapy."

Xeloda is an oral chemotherapy that can be taken at home and as
such it has an important convenience benefit for both patients and
doctors compared to intravenous infusions which require multiple
hospital visits. This targeted cancer medicine is already used in
previously untreated colorectal cancer patients and last year Xeloda
received the additional approval for the treatment of early
(adjuvant) colon cancer.

Results from the NO16967 study will be submitted for presentation
at future major medical meetings.

"Our data complement the findings of the NO16966 study, suggesting
that XELOX is a very reasonable treatment option for patients with
recurrent colorectal cancer," said Mace Rothenberg, MD, lead
investigator and Professor of Medicine at Vanderbilt University
Medical Center and Ingram Professor of Cancer Research at
Vanderbilt-Ingram Cancer Center. "By demonstrating that Xeloda in
combination with oxaliplatin was as effective as FOLFOX-4, these two
studies provide the strongest evidence yet that Xeloda may be used in
place of IV 5-FU in the treatment of patients with advanced
colorectal cancer."

In 2004, colorectal cancer was one of the leading cancers and
accounted for 13 percent of all cancers.(1) It is estimated that more
than 394,000 people die worldwide from colorectal cancer each
year.(2)

About the Study

The NO16967 trial is a large, international phase III trial which
randomized 627 patients from 15 countries world-wide who had
previously received chemotherapy and whose disease had returned or
continued to progress.

The primary objective was to answer whether the XELOX regimen
(Xeloda plus oxaliplatin) is as effective as FOLFOX 4 (intravenous
bolus and infusional 5-fluorouracil/leucovorin plus oxaliplatin) in
delaying disease progression or death. The secondary outcomes, to be
reviewed included overall survival, overall response rates, and
safety profile.

About XELOX

An abbreviation for a type of combination chemotherapy used to
treat colorectal cancer; it contains Xeloda (capecitabine) plus
oxaliplatin.

About Xeloda (capecitabine)

Xeloda is licensed in more than 90 countries worldwide including
the EU, USA, Japan, Australia and Canada and has been shown to be an
effective, safe, simple and convenient oral chemotherapy in treating
over 1 million patients to date.

Roche received marketing authorisation for Xeloda as a first-line
monotherapy (by itself) in the treatment of metastatic colorectal
cancer (colorectal cancer that has spread to other parts of the body)
in most countries (including the EU and USA) in 2001. Xeloda has also
been approved by the European Medicines Agency (EMEA) and U.S. Food
and Drug Administration (FDA) for adjuvant (post-surgery) treatment
of colon cancer in March and June 2005, respectively.

Xeloda is licensed in combination with Taxotere (docetaxel) in
women with metastatic breast cancer (breast cancer that has spread to
other parts of the body) and whose disease has progressed following
intravenous (i.v.) chemotherapy with anthracyclines. Xeloda
monotherapy is also indicated for treatment of patients with
metastatic breast cancer that is resistant to other chemotherapy
drugs such as paclitaxel and anthracyclines. Xeloda is licensed for
the first-line treatment of stomach cancer that has spread, in South
Korea.

The most commonly reported adverse events with Xeloda include
diarrhoea, abdominal pain, nausea, stomatitis and hand-foot syndrome
(palmar-plantar erythrodysesthaesia).

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world's
leading research-focused healthcare groups in the fields of
pharmaceuticals and diagnostics. As a supplier of innovative products
and services for the early detection, 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 2005
sales by the Pharmaceuticals Division totalled 27.3 billion Swiss
francs, and the Diagnostics Division posted sales of 8.2 billion
Swiss francs. Roche employs roughly 70,000 people in 150 countries
and has R&D agreements and strategic alliances with numerous
partners, including majority ownership interests in Genentech and
Chugai. Additional information about the Roche Group is available on
the Internet (www.roche.com).

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

Additional information

- Roche in Oncology:
www.roche.com/pages/downloads/company/pdf/mboncology05e_b.pdf

- Roche Health Kiosk, Cancer: www.health-kiosk.ch/start_krebs

References:

1. Boyle P, Ferlay J. Cancer incidence and mortality in Europe,
2004. Annals of Oncology 2005; 16:481-488

2. Boyle P, Langman JS. ABC of colorectal cancer. Epidemiology.
BMJ 2000; 321:805-808

ots Originaltext: Roche Pharmaceuticals
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Roche Group Media Office: Telephone: +41-61-688-8888 / Email:
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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