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OCREVUS (ocrelizumab) data show early initiation of treatment reduces disability progression over five years in relapsing and primary progressive multiple sclerosis

F. Hoffmann-La Roche Ltd /
OCREVUS (ocrelizumab) data show early initiation of treatment reduces disability
progression over five years in relapsing and primary progressive multiple
sclerosis
. Processed and transmitted by West Corporation.
The issuer is solely responsible for the content of this announcement.

* People with relapsing MS (RMS) treated sooner with OCREVUS had earlier
reduction in disease activity and less disability progression vs. those who
switched from interferon beta-1a
* People with primary progressive MS (PPMS) treated with OCREVUS earlier had
less disability and upper limb progression than those who switched from
placebo
* Longer-term safety data are consistent with OCREVUS' favourable benefit-risk
profile for both RMS and PPMS
* OCREVUS approved in 68 countries, with over 70,000 patients treated globally

Basel, 10 October 2018 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that
new OCREVUS® (ocrelizumab) data will be presented at the 34(th) Congress of the
European Committee for the Treatment and Research in Multiple Sclerosis
(ECTRIMS) from 10 October to 12 October in Berlin, Germany. Five-year data from
the Phase III open-label extension studies of OPERA I, OPERA II and ORATORIO
show OCREVUS efficacy is maintained on key measures of disease activity and that
people treated earlier with OCREVUS had superior disability progression outcomes
compared with RMS patients who switched from interferon beta-1a or PPMS patients
who switched from placebo.

"From the moment of diagnosis, reducing disease progression is an important goal
for people with MS. The new data presented at ECTRIMS demonstrate that OCREVUS'
efficacy continued over five years in relapsing and primary progressive MS, and
notably, include the largest body of evidence for any medicine to significantly
slow disability progression in primary progressive MS," said Stephen Hauser, MD,
chair of the Scientific Steering Committee of the OPERA studies, professor of
neurology at the University of California, San Francisco, and director of the
UCSF Weill Institute for Neurosciences. "The data also suggest that OCREVUS
rapidly suppressed relapse and MRI disease activity in people with relapsing MS
who switched from interferon beta-1a, and additionally, that earlier treatment
with OCREVUS reduced disability progression and brain atrophy."


Multimedia asset:


Delaying disease progression in MS



In the open-label extension of the Phase III OPERA I and OPERA II trials, people
with RMS who had continuous OCREVUS treatment over five years had better
outcomes in brain atrophy and confirmed disability progression (CDP) than
patients who switched to OCREVUS after the first two years of interferon beta-
1a treatment. People with RMS who initiated OCREVUS two years earlier maintained
lower whole brain, white matter and cortical grey matter tissue loss after five
years of continuous treatment. People with RMS who initiated OCREVUS treatment
two years earlier achieved significant and sustained reductions in 24-week CDP
compared to those who switched from interferon beta-1a (16.1 percent vs. 21.3
percent progression after Year 5, respectively, p=0.014).

Additionally, people with RMS who switched to OCREVUS from interferon beta-1a
after the controlled trial period had a rapid suppression of disease activity,
measured with annualized relapse rate and MRI measures of T1-gadolinium
enhancing (T1-Gd+) lesions and new/enlarging T2 (N/E T2) lesions. Switching to
OCREVUS reduced the annualized relapse rate from 0.2 pre-switch to 0.07 after
three years of OCREVUS treatment. People also experienced near-complete
suppression of T1-gadolinium enhancing (T1-Gd+) lesions from 0.49 lesions/scan
on interferon beta-1a treatment to 0.004 lesions/scan after three years of
OCREVUS treatment. Similarly, the number of new or enlarging T2 (N/E T2) lesions
were suppressed from 2.58 to 0.038 lesions/scan.

PPMS patients who were treated with OCREVUS three to five years earlier had less
disability progression in the open-label extension study of the Phase III
ORATORIO trial. Disability progression was significantly reduced by 9.6 percent
in people who were continuously treated with OCREVUS compared with those who
switched from placebo as measured by 24-week CDP (p=0.023). Upper limb
disability progression, measured by the nine-hole peg test (9-HPT), was
significantly reduced by 13.4 percent in people who were continuously treated
with OCREVUS compared with those who switched from placebo (p=0.001).

Furthermore, data from the open-label Phase IIIb CHORDS study evaluating OCREVUS
in people with relapsing-remitting MS (RRMS) who had a suboptimal response to at
least six months of treatment with another disease-modifying therapy will be
presented. An interim analysis shows 59 percent of people who switched to
OCREVUS had no relapse, no T1-Gd+ lesion MRI activity, no N/E T2 lesion MRI
activity and no 24-week CDP at 48 weeks.

Ongoing safety data presented at ECTRIMS representing 3,811 RMS and PPMS
patients and 10,919 patient years of exposure to OCREVUS, across all OCREVUS
clinical trials, remain consistent with the medicine's favourable benefit-risk
profile.

A post-hoc analysis of the ORATORIO study demonstrating OCREVUS treatment
increased the proportion of patients with PPMS who achieved no evidence of
progression or active disease (NEPAD), a comprehensive measure of MS, compared
to placebo were published 29 August in Annals of Neurology.
https://onlinelibrary.wiley.com/doi/10.1002/ana.25313

OCREVUS is now approved in 68 countries across North America, South America, the
Middle East, Eastern Europe, as well as in Australia, Switzerland and the
European Union. As of October 2018, over 70,000 people have been treated
globally with OCREVUS. Marketing applications are currently under review in more
than 20 countries across the world.

About OCREVUS (ocrelizumab)
OCREVUS is a humanised monoclonal antibody designed to selectively target CD20-
positive B cells, a specific type of immune cell thought to be a key contributor
to myelin (nerve cell insulation and support) and axonal (nerve cell) damage.
This nerve cell damage can lead to disability in people with multiple sclerosis
(MS). Based on preclinical studies, OCREVUS binds to CD20 cell surface proteins
expressed on certain B cells, but not on stem cells or plasma cells, and
therefore important functions of the immune system may be preserved.

OCREVUS is administered by intravenous infusion every six months. The initial
dose is given as two 300 mg infusions given two weeks apart. Subsequent doses
are given as single 600 mg infusions.

About Roche in neuroscience
Neuroscience is a major focus of research and development at Roche. The
company's goal is to develop treatment options based on the biology of the
nervous system to help improve the lives of people with chronic and potentially
devastating diseases. Roche has more than a dozen investigational medicines in
clinical development for diseases that include multiple sclerosis, Alzheimer's
disease, spinal muscular atrophy, Parkinson's disease and autism.

About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on
advancing science to improve people's lives. The combined strengths of
pharmaceuticals and diagnostics under one roof have made Roche the leader in
personalised healthcare - a strategy that aims to fit the right treatment to
each patient in the best way possible.

Roche is the world's largest biotech company, with truly differentiated
medicines in oncology, immunology, infectious diseases, ophthalmology and
diseases of the central nervous system. Roche is also the world leader in in
vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in
diabetes management.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose
and treat diseases and make a sustainable contribution to society. The company
also aims to improve patient access to medical innovations by working with all
relevant stakeholders. Thirty medicines developed by Roche are included in the
World Health Organization Model Lists of Essential Medicines, among them life-
saving antibiotics, antimalarials and cancer medicines. Moreover, for the tenth
consecutive year, Roche has been recognised as the most sustainable company in
the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100
countries and in 2017 employed about 94,000 people worldwide. In 2017, Roche
invested CHF 10.4 billion in R&D and posted sales of CHF 53.3 billion.
Genentech, in the United States, is a wholly owned member of the Roche Group.
Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more
information, please visit www.roche.com.

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


Roche Group Media Relations
Phone: +41 -61 688 8888 / e-mail: media.relations@roche.com
- Nicolas Dunant (Head)
- Patrick Barth
- Ulrike Engels-Lange
- Simone Oeschger
- Anja von Treskow

Roche-Media-Release_ECTRIMS_Ocrevus_Data_EN:
http://hugin.info/174806/R/2219773/868365.pdf



This announcement is distributed by West Corporation on behalf of West Corporation clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: F. Hoffmann-La Roche Ltd via GlobeNewswire



 
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