MabThera Significantly Reduces Risk of Serious Bleeding in People With Life-Threatening Autoimmune Disorder

Basel, Switzerland (ots/PRNewswire) -

- For Non-US and Non-UK Media Only

- Abstract Number: 1

- New Phase III Data Suggest Potential Role for MabThera in
Treating Blood Disorder

New data presented at the 50th Annual Meeting of the American
Society of Hematology (ASH) today, show that people living with a
previously untreated bleeding disorder, idiopathic thrombocytopenic
purpura (ITP), who received MabThera (rituximab) in combination with
standard management were able to prevent bleeding for longer than
those receiving standard treatment alone.

Data from the phase III study, which is the first randomised
study to evaluate the use of MabThera in treating platelet disorders,
shows that patients with ITP who were given MabThera and standard
treatment were able to maintain their blood platelet count for longer
thereby avoiding potentially life threatening bleeding in vital
organs such as the brain.

"People with chronic ITP and very low platelet counts live with
the threat of bleeding. The aim of treatment is to stop blood
platelet counts falling to help prevent this from happening. These
data show that patients receiving MabThera experience an immediate
benefit" said Francesco Zaja from the University of Udine, Italy, and
principle investigator for the study.

ITP is an autoimmune disease in which the body attacks its own
blood cells (platelets) or does not produce enough blood cells to
protect itself. This means the blood does not clot properly and can
result in easy bruising, nose bleeds, bleeding from the gums, gut,
and bleeding in the brain. ITP is either an acute condition in
children or a chronic condition in adults. Chronic ITP predominantly
affects adults (median age around 50 years) and is more common in
women.

"The long period of time without the disease recurring shows that
in some patients MabThera offers the potential for cure," said
Francesco Zaja. "This is extremely good news for people with this
potentially life-threatening condition as current forms of treatment
only aim to relieve symptoms rather than cure the condition itself."

About the study

The study is a phase III study designed to assess the monoclonal
antibody MabThera in combination with oral corticosteroid
dexamethasone in adult patients with previously untreated ITP. 101
patients previously untreated for ITP with a blood platelet count of
less than 20 x 10 to the power of 9/L were involved in the study,
which was conducted between July 2005 and June 2007. Of these, 49
patients received MabThera in combination with dexamethasone and 52
patients received dexamethasone alone. The primary endpoint was
sustained response rate, i.e. a blood platelet count of more than 50
x 10 to the power of 9/L after six months. The results were analysed
by an intention to treat (ITT) and by a per protocol (PP) analysis.

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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
Mobile: +41-7957-25193
Email: peter.bayliss@roche.com
Amber Bradbury
Ketchum
Phone: +44-7793-681615
Email: amber.bradbury@ketchum.com

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

Contact:
For more information, please contact: Peter Bayliss, Roche, Mobile:
+41-7957-25193, Email: peter.bayliss@roche.com; Amber Bradbury,
Ketchum, Phone: +44-7793-681615, Email: amber.bradbury@ketchum.com