Latest Data Show MabThera(R) Provides Significant and Sustained Relief From Signs and Symptoms of Rheumatoid Arthritis

Latest Data Show MabThera(R) Provides Significant and Sustained Relief From Signs and Symptoms of Rheumatoid Arthritis

June 13, 2007

Patients Experience Consistent Safety Profile With
Subsequent Courses of Therapy


    BARCELONA, Spain, June 13 /Xinhua-PRNewswire/ -- New
data presented at the EULAR meeting (European League
Against Rheumatism) demonstrate that MabThera's (rituximab)
effectiveness in relieving patients of the distressing
symptoms of rheumatoid arthritis (RA) is sustained or
further improved with subsequent courses of treatment, as
is the number of patients achieving remission(1).
Importantly, the safety profile of MabThera remained
unchanged in patients who had received as many as seven
courses of treatment at 6-12 month intervals.

    Commenting on the findings, Professor Keystone,
Rheumatology Department at the University of Toronto,
Canada, said: "As physicians gain experience with
MabThera and the long-term efficacy and safety data are
collected, we are able to make treatment decisions with
confidence for the ultimate benefit of our patients."

    Results following subsequent courses of therapy

    A total of 1053 RA patients was treated with MabThera
with almost 70% of patients followed up for more than two
years and 11% for more than three years. The study was
conducted in patients who had an inadequate response to
treatment with either tumour necrosis factor (TNF)
inhibitors or disease-modifying anti-rheumatic drugs
(DMARDs), both of which are commonly used classes of RA
drugs. All study patients received multiple courses of
MabThera (2 x1000mg infusion, 2 weeks apart) based on
disease activity.

    The data showed that after three courses of MabThera in
patients who had an inadequate response to TNF inhibitors:

    - The number of patients achieving the hard-to-reach
goal of a 70%
      improvement in disease signs and symptoms (ACR70
response(2)) almost 
      tripled from 11% to 25%

    - The number of patients achieving remission improved
from 6% to 12%

    Equally, in patients with an inadequate response or
intolerance to DMARDs, the remission rate increased almost
threefold from 5% to 14% confirming the benefit of
providing subsequent courses to responding patients.

    Long-term safety of MabThera

    Further pooled data examining the safety of MabThera
when used long-term revealed that the safety profile of
MabThera remained consistent with a low, unchanging rate of
serious infections in 1053 patients, receiving up to seven
treatment courses. These results add to the wealth of data
contributing to MabThera's safety profile with 2438
patient-years of follow-up now collected.

    Editor's Notes

    About Rheumatoid Arthritis and MabThera

    Rheumatoid arthritis is an autoimmune disease
characterised by inflammation that leads to stiff, swollen
and painful joints. Current treatments include
disease-modifying drugs (DMARDS) and biologic therapy such
as the TNF inhibitor drugs.

    MabThera is a first-in-class therapy that selectively
targets B cells early in the inflammatory cascade of
rheumatoid arthritis. B cells are known to play a key role
in the inflammation associated with rheumatoid arthritis
and MabThera breaks the inflammatory cascade of RA - a
series of reactions inflaming the synovia and leading to
the cartilage loss and bone erosion that is characteristic
of the disease, and may provide an innovative new treatment
even in patients with severe and long-standing disease. 
MabThera has a strong heritage in the treatment of a form
of lymphatic cancer called non-Hodgkin's lymphoma (NHL) and
the safety profile of MabThera has now been established in
more than 960,000 patient exposures over the last nine
years in oncology and autoimmune disease.

    About Roche in Rheumatoid Arthritis

    One of the most important drivers for growth at Roche
over the next few years is expected to be the company's
emerging franchise in autoimmune diseases with rheumatoid
arthritis as the first indication.  Following the launch of
MabThera, there are a number of projects in development,
potentially allowing Roche to build on further
opportunities.  MabThera is the first and only selective B
cell therapy for RA, providing a fundamentally different
treatment approach by targeting B cells, one of the key
players in the pathogenesis of RA. Actemra is Roche's
second novel medicine and is a humanised monoclonal
antibody to the interleukin-6 (IL-6) receptor, inhibiting
the activity of IL-6, a protein that plays a major role in
the RA inflammation process. Actemra is the result of
research collaboration by Chugai and is being co-developed
globally with Chugai.  Additional projects creating a rich
pipeline include compounds in Phase I, II and III clinical
trials. Notably, ocrelizumab, a fully humanised anti-CD20
antibody, is just entering phase III development for RA.

    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 the
world's biggest biotech company and an innovator of
products and services for the early detection, prevention,
diagnosis and treatment of diseases, the Group contributes
on a broad range of fronts to improving people's health and
quality of life. Roche is the world leader in in-vitro
diagnostics and drugs for cancer and transplantation, a
market leader in virology and active in other major
therapeutic areas such as autoimmune diseases,
inflammation, metabolism and central nervous system. In
2006 sales by the Pharmaceuticals Division totalled 33.3
billion Swiss francs, and the Diagnostics Division posted
sales of 8.7 billion Swiss francs. Roche employs
approximately 75,000 worldwide 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 at http://www.roche.com .

    All trademarks used or mentioned in this release are
protected by law.

    For a selection of broadcast footage clips relating to
MabThera and rheumatoid arthritis please visit
http://www.thenewsmarket.com/roche 

    To view and download high resolution stills and media
materials please visit the MabThera Virtual Press Office at
http://www.mabthera-ra.com 

    References

    (1) Disease activity is measured by a Disease Activity
Score (DAS), where
        low disease activity is defined as DAS 28 less than
or equal 3.2 and 
        remission is defined as DAS 28 less than or equal
to 2.6
    (2) The ACR response is a standard assessment used to
measure patients'
        responses to anti-rheumatic therapies, devised by
the American College 
        of Rheumatology (ACR). It requires a patient to
have a defined 
        percentage reduction in a number of symptoms and
measures of their 
        disease. For example, a 20%, 50% or 70% level of
reduction is 
        represented as ACR20, ACR50 or ACR70. An ACR70
response is exceptional 
        for existing treatments and represents a
significant improvement in a 
        patient's condition.

 


    For more information, please contact: 

    Roche:
     Jennifer Wilson (on site)
     International Communications Manager
     Tel: [phone]

    Cohn & Wolfe:

     Lucy Heaton (on site)
     Tel: [phone]

     Lynn Huynh (UK)
     Tel: [phone]