Herceptin Receives Positive Opinion in Europe for Early Use in HER2-Positive Breast Cancer

Basel, Switzerland (ots/PRNewswire) -

- Important Step Towards Broad Access of Herceptin for Women With
Aggressive Form of Breast Cancer

Roche today announced that the European Union's Committee for
Human Medicinal Products (CHMP) has issued a positive recommendation
for the use of Herceptin following surgery and standard chemotherapy
as adjuvant treatment of early-stage HER2-positive breast cancer.
HER2-positive breast cancer, which affects approximately 20% -
30%[i] of women with breast cancer, demands special and immediate
attention because the tumours are fast-growing and there is a higher
likelihood of relapse.

The CHMP's decision is based on impressive results from the
international HERA (HERceptin Adjuvant) study which showed Herceptin
following standard chemotherapy significantly reduces the risk of
cancer coming back by 46% compared to chemotherapy alone. [ii] These
remarkable benefits have also been seen in three other major global
and US studies.[iii]

"The results from four large-scale trials speak for themselves:
Herceptin consistently reduces the risk of relapse when used in early
stages, providing the best chance of long-term survival to women with
an extremely aggressive form of breast cancer," commented Ed
Holdener, Head of Roche's Global Pharma Development. "The CHMP's
timely decision represents a significant milestone, bringing patients
and the medical community one step closer to broadly accessing this
effective therapy in the EU."

The positive opinion will now be proposed for approval by the
European Commission. Herceptin is the only approved therapy
specifically for the treatment of metastatic (advanced) HER2-positive
disease, so the new approval will allow Herceptin to be used
following surgery for early-stage breast cancer, as `adjuvant'
therapy.

In the US, Genentech filed a supplemental Biologic License
Application (sBLA) for the use of Herceptin in early-stage
HER2-positive breast cancer with the Food and Drug Administration
(FDA) on February 15th, 2006. The application is based on data from
the combined interim analysis of two large US trials,[iv] and
Genentech has received a priority review designation.

About the HERA study

HERA, conducted by the Roche and Breast International Group
(BIG),[v] is one of the largest adjuvant studies ever carried out
among breast cancer patients; enrolment to the trial began in
December 2001, and nearly 5,100 HER2-positive patients were enrolled
at 480 sites in 39 countries across the world. HERA is a randomised
trial, which, following standard adjuvant systemic chemotherapy and
radiotherapy (if applicable), evaluates observation versus Herceptin
every three weeks for 12 months or 24 months in women with
early-stage HER2-positive breast cancer. The HERA study allowed for
the use of a wide range of chemotherapy regimens, and both lymph
node-positive and lymph node-negative patients were eligible for
entry into the trial.

According to the interim analysis, the primary efficacy endpoint
was met, showing that in the 12-month arm, patients who received
Herceptin had a statistically significant improvement in disease-free
survival (the length of time after treatment during which no disease
is found). At a median follow-up of one year, the secondary endpoint
of overall survival had not reached statistical significance, but
showed a clear trend towards an improvement in overall survival,
which is to be confirmed as the data mature.

The interim analysis compared Herceptin versus observation and did
not include a comparison of 12 months versus 24 months treatment
duration. The trial will continue to assess this comparison and data
will become available in due time as the study matures.

The HERA study has an external Independent Data Monitoring
Committee (IDMC) that regularly reviews safety data. No safety
concerns were raised by the IDMC, and the incidence of congestive
heart failure was very low (0.5% in the Herceptin arms vs. 0% in the
observation arm). Patients in this study will continue to be followed
for any side effects.

About breast cancer and Herceptin

Eight to nine percent of women will develop breast cancer during
their lifetime, making it one of the most common types of cancer in
women.[vi] Each year more than one million new cases of breast cancer
are diagnosed worldwide, with a death rate of nearly 400,000 people
per year.

In HER2-positive breast cancer, increased quantities of the HER2
protein are present on the surface of the tumour cells. This is known
as `HER2 positivity.' High levels of HER2 are present in a
particularly aggressive form of the disease which responds poorly to
chemotherapy. Research shows that HER2-positivity affects
approximately 20-30% of women with breast cancer.

Herceptin is a humanised antibody, designed to target and block
the function of HER2, a protein produced by a specific gene with
cancer-causing potential. In addition to its efficacy in the
early-stage breast cancer setting, Herceptin also has demonstrated
improved survival in the advanced (metastatic) setting, where its
addition to chemotherapy allows patients to live up to one-third
longer than chemotherapy alone.[vii]

Herceptin received approval in the European Union in 2000 for use
in patients with metastatic breast cancer, whose tumours overexpress
the HER2 protein. In addition to being indicated for use in
combination with docetaxel as a first-line therapy in HER2-positive
patients who have not received chemotherapy for their metastatic
disease, it is also indicated as a first-line therapy in combination
with paclitaxel where anthracyclines are unsuitable, and as a single
agent in third-line therapy. Herceptin is marketed in the United
States by Genentech, in Japan by Chugai and internationally by Roche.
Since 1998, Herceptin has been used to treat over 230,000
HER2-positive breast cancer patients worldwide.

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:

- About Genentech: www.gene.com

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

- Roche Health Kiosk on cancer: www.health-kiosk.ch/start_krebs

To access video clips, in broadcast standard, free of charge,
please go to: www.thenewsmarket.com.

References:

[i] Harries M, Smith I. The development and clinical use of
trastuzumab (Herceptin). Endocr Relat Cancer 9: 75-85, 2002.

[ii] Piccart-Gebhart M, Procter M, Leyland-Jones B, et al. A
Randomized Trial of Trastuzumab Following Adjuvant Chemotherapy in
Women with HER2 Positive Breast Cancer. New England Journal of
Medicine 353:16 2005.

[iii] NCCTG N9831 (US), NSABP B-31 (US), BCIRG 006 (international)

[iv] Romond, E., Perez, E. et al. Trastuzumab plus Adjuvant
Chemotherapy for Operable HER2 Positive Breast Cancer. New England
Journal of Medicine 353:16 2005.

[v] Collaborative partners for the HERA study include: Roche, BIG
and its affiliated collaborative groups, plus non-affiliated
collaborative groups, and independent sites.

[vi] World Health Organization, 2000.

[vii] Extra JM, Cognetti F, Maraninchi D et al. Long-term survival
demonstrated with trastuzumab plus docetaxel: 24-month data from a
randomised trial (M77001) in HER2-positive metastatic breast cancer.
Abstract #555, American Society for Clinical Oncology (ASCO) Annual
Meeting 2005.

ots Originaltext: Roche Pharmaceuticals
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Contact:
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basel.mediaoffice@roche.com, Baschi Dürr, Alexander Klauser, Daniel
Piller (Head of Roche Group Media Office), Katja Prowald (Head of R&D
Communications), Martina Rupp