Asia PR News

BASEL, Switzerland, July 28 /PRNewswire–AsiaNet/ –

Roche announced today that its cancer medicine Tarceva (erlotinib) has
received a negative opinion from the European Committee for Medicinal Products
for Human Use (CHMP) for use in combination with gemcitabine chemotherapy for
the first line treatment of advanced pancreatic cancer, a cancer with an
extremely high fatality rate(1). Roche is confident in the trial data, which
has shown that the Tarceva combination treatment significantly increases
patient survival. In the interest of the patients, Roche will now consider all
options following this decision, including requesting a re-examination of this
decision.

Tarceva has already been approved by the American Food and Drug
Administration in November 2005 for the first-line treatment of patients with
locally advanced, unresectable or metastatic pancreatic cancer in combination
with gemcitabine chemotherapy. Both the US and the EU application are based on
data from the Phase III study (PA3)(2) which showed that treatment with
Tarceva plus gemcitabine results in significantly longer survival compared to
gemcitabine alone (22%). In addition, 24% of patients receiving Tarceva plus
gemcitabine were alive after one year, compared to 19% on gemcitabine alone.

"Pancreatic cancer is one of the most aggressive forms of cancer and it
kills more people within the first year of diagnosis than any other cancer,"
said Eduard Holdener, Head of Global Drug Development. "Given such a poor
outlook, even modest improvements in survival are valuable to advanced stage
patients."

Despite significant advances in the treatment of many other tumors, the
five year survival rate for men and women diagnosed with pancreatic cancer has
not changed in decades(1). Treatment options for patients are extremely
limited and Tarceva is the first treatment for many years to have shown a
significant survival benefit in patients with pancreatic cancer.

Roche and its partners are committed to realizing the potential of Tarceva
in treating pancreatic cancer through its extensive clinical trial programme,
including a Roche-sponsored randomized, double blind, placebo controlled study
of gemcitabine and Tarceva+/- Avastin in patients with metastatic pancreatic
cancer (AVITA or BO17706). Tarceva is approved and marketed in the US and
across the European Union for patients with locally advanced or metastatic
non-small cell lung cancer (NSCLC) after failure of at least one prior
chemotherapy regimen.

A variation application was submitted to the European Health Authorities
in October 2005 for Tarceva plus gemcitabine chemotherapy for the first-line
treatment of patients with advanced pancreatic cancer. In April 2006, Chugai
Pharmaceutical Co., Ltd. filed a New Drug Application (NDA) with the Japanese
Ministry of Health, Labour and Welfare (MHLW) for Tarceva in patients with
advanced or recurrent NSCLC.

About the PA3 study(2)

The pivotal Phase III randomized study (PA3)(2) of 569 patients was
conducted by the National Cancer Institute of Canada Clinical Trials Group
based at Queen’s University. The double blind study evaluated Tarceva’s
efficacy in patients with locally advanced or metastatic pancreatic cancer.

The results of PA32 demonstrated the following:

— Treatment with Tarceva plus gemcitabine in patients with advanced
pancreatic cancer resulted in significantly longer survival compared to
gemcitabine alone (22%)

— 24% of patients receiving Tarceva plus gemcitabine were alive after one
year, compared to 19% on gemcitabine alone

— Patients receiving Tarceva plus gemcitabine experienced significantly
longer progression-free survival of 30%

— Tarceva plus gemcitabine was well tolerated by patients with no
increase in haematological toxicity; as expected rash and diarrhoea
were the principal Tarceva-related side effects seen in the study and
were generally characterized as mild-to-moderate

— Tarceva plus gemcitabine reported a safety profile generally consistent
with that seen in other studies both monotherapy and combination
settings

About pancreatic cancer
Pancreatic cancer is the tenth most frequently occurring cancer in
Europe(3) The main risk factors for pancreatic cancer include advanced age,
cigarette smoking, a high-fat diet, diabetes mellitus, chronic inflammation of
the pancreas (pancreatitis), especially hereditary pancreatitis, and a family
history of pancreatic cancer(4). The symptoms vary depending upon where the
tumor is in the pancreas. The major symptoms are weight loss, abdominal pain
and jaundice(1). The disease is rapidly fatal and attempts to improve survival
over the past 10 years have been unsuccessful.

About Tarceva
Tarceva (erlotinib) is an investigational small molecule that targets the
human epidermal growth factor receptor (HER1) pathway. HER1, also known as
EGFR, is a key component of this signaling pathway, which plays a role in the
formation and growth of numerous cancers. Tarceva blocks tumor cell growth by
inhibiting the tyrosine kinase activity of the HER1 signaling pathway inside
the cell.

Taken as an oral, once-daily therapy, Tarceva is the only EGFR-inhibitor
to have demonstrated a survival benefit in lung cancer — a striking 42.5%.
Currently most lung cancer patients are treated with chemotherapy, which can
be very debilitating due to its toxic nature. Tarceva works differently to
chemotherapy by specifically targeting tumor cells, and avoids the typical
side-effects of chemotherapy.

Tarceva is approved in the US and across the EU for patients with locally
advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at
least one prior chemotherapy regimen.

Tarceva has been approved by the FDA since November 2, 2005 for treatment
of locally advanced, unresectable or metastatic pancreatic cancer in
combination with gemcitabine chemotherapy.

Tarceva is currently being evaluated in an extensive clinical development
programme by a global alliance among OSI Pharmaceuticals, Genentech, and
Roche, focusing on earlier stages of NSCLC. Additionally, Tarceva is being
studied in combination with Avastin in NSCLC. Trials are also being conducted
with Tarceva in other solid tumors, such as ovarian, bronchioloalveolar (BAC),
colorectal, pancreatic, head and neck and glioma (brain).

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 totaled 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 (http://www.roche.com).

All trademarks used or mentioned in this release are protected by law.

For further information about:

- Cancer: http://www.health-kiosk.ch

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

- Genentech: http://www.gene.com

- OSI Pharmaceuticals: http://www.osip.com

References:

1. Steward, B W and Kleihues, P. 2003. World Cancer Report. World Health
Organisation and the International Agency for Research on Cancer, IARC
Press/Lyon, p248

2. Moore MJ, Goldstein D, Hamm J, et al. Erlotinib plus gemcitabine
compared to gemcitabine alone in patients with advanced pancreatic
cancer. A Phase III trial of the National Cancer Institute of Canada
Clinical Trials Group (NCIC-CTG). (Abstract #1, ASCO 2005)

3. De Braud F, Cascinu S, Gatta G. 2004, May. Cancer of Pancreas.
Critical reviews in oncology/hematology, 50(2):147-55

4. Truninger K (ed). 2002, Aug. Risk groups for pancreatic and bile duct
carcinomas. Schweizerische Rundschau fur Medizin Praxis, 17;89
(33):1299-304

SOURCE: Roche

CONTACT: Roche Group Media Office
+41-61-688-8888
basel.mediaoffice@roche.com - Baschi Durr
- Alexander Klauser - Daniel Piller
- Head of Roche Group Media Office - Katja
Prowald - Head of R&D
Communications - Martina Rupp