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

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

July 31, 2006

    BASEL, Switzerland, July 31 /Xinhua-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 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

    For more information, please contact:

    Roche Group Media Office

     Baschi Durr, Alexander Klauser or Martina Rupp, or
     Daniel Piller, Head of Roche Group Media Office, or 
     Katja Prowald, Head of R&D Communications, 
     Tel:   [phone]
     Email: [e-mail]   

SOURCE  Roche