In the Interests of Patients, Roche Will Consider all Options Following CHMP Opinion on Tarceva in Pancreatic Cancer

Basel, Switzerland (ots/PRNewswire) - 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
tumours, 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 realising the potential of
Tarceva in treating pancreatic cancer through its extensive clinical
trial programme, including a Roche-sponsored randomised, 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 randomised 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 characterised 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 tumour 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 signalling
pathway, which plays a role in the formation and growth of numerous
cancers. Tarceva blocks tumour cell growth by inhibiting the tyrosine
kinase activity of the HER1 signalling 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 tumour 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, focussing 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
tumours, 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 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 protected by
law.

For further information about:

- Cancer: www.health-kiosk.ch

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

- Genentech: www.gene.com

- OSI Pharmaceuticals: 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

ots Originaltext: Roche Pharmaceuticals
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