MabThera Filed in the EU for Treatment of Most Common Leukaemia in Adults

Basel, Switzerland (ots/PRNewswire) -

- Submission Based on Phase III Study Showing Superior Results
for MabThera in Chronic Lymphocytic Leukaemia (CLL) When Added to
Standard Chemotherapy

Today, Roche submitted a Marketing Authorisation Application
(MAA) to the European Medicines Agency (EMEA) for the use of its
biotechnology drug MabThera (rituximab) as first-line treatment of
chronic lymphocytic leukaemia, the most common form of adult
leukaemia.

The filing is based on data from the Pivotal Phase III CLL8 study
(ML17102), initiated by the German CLL Study Group (GCLLSG), which
showed at interim analysis that treatment with MabThera in
combination with the current standard chemotherapy achieved a
significantly better outcome, compared to patients treated with
chemotherapy alone. The study was powered to show an increase in
progression free survival when the MabThera-based combination was
used.

Full results of the CLL8 study will be submitted for presentation
at the annual meeting of the American Society of Haematology (ASH) in
San Francisco in December this year.

Chronic Lymphocytic Leukaemia (CLL) is the most common type of
leukaemia in adults, accounting for approximately 25-30% of all forms
of leukaemia. Incidence of CLL in Western countries is around 2-4 per
100,000, and is twice as common in men compared to women. It mainly
affects the elderly with 95% of patients diagnosed after the age of
55. While CLL is generally considered a disease that it is slow to
progress, a significant proportion of patients have rapidly
progressing forms of the disease.

About the study

The CLL8 study is an international study and included 817
patients with CLL receiving first-line treatment. The study was
conducted at 191 study sites across 11 countries. In this randomized
study, patients received either MabThera in combination with
chemotherapy (fludarabine and cyclophosphamide) or chemotherapy
alone. The primary endpoint of the study was progression free
survival. No new or unexpected safety signals were observed.

Additional information is available on the Internet at
http://www.roche.com. All trademarks used or mentioned in this
release are legally protected.

Further Information:

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

- Lymphoma: http://www.lymphoma-net.org
- The Lymphoma Coalition: http://www.lymphomacoalition.org
- Cancer: http://www.health-kiosk.ch/start_krebs.htm
- World Health Organization: http://www.who.int
For more information, please contact:
Peter Bayliss
Roche
Phone: +41-61-687-97-35
Email: peter.bayliss@roche.com
Natalie Fairbank
Ketchum
Phone: +44-207-611-3660
Email: natalie.fairbank@ketchum.com

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

Contact:
For more information, please contact: Peter Bayliss, Roche, Phone:
+41-61-687-97-35, Email: peter.bayliss@roche.com. Natalie Fairbank,
Ketchum, Phone: + 44-207-611-3660, Email:
natalie.fairbank@ketchum.com