-- 85% of treatment-naïve, early-stage relapsing-remitting multiple 
      sclerosis (RRMS) patients achieved no evidence of disease activity (NEDA) 
      in open-label Phase IIIb ENSEMBLE study 
 
   -- OCREVUS significantly slowed loss of brain tissue within T2 MRI lesions 
      in primary progressive multiple sclerosis (PPMS) in post-hoc analysis of 
      Phase III ORATORIO study 
 
   -- OCREVUS-treated patients show highest adherence and persistence rates 
      compared with other disease-modifying therapies (DMTs) in two-year U.S. 
      claims analysis 
 
   Basel, 16 April 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today 
announced new OCREVUS(R) (ocrelizumab) analyses supporting its 
significant benefit on disease progression in early-stage 
relapsing-remitting multiple sclerosis (RRMS) and primary progressive MS 
(PPMS) as well as demonstrating high persistence and strong adherence to 
twice-yearly (six-monthly) dosing. These data are being presented 
virtually at the 73rd American Academy of Neurology (AAN) Annual Meeting 
from 17--22 April 2021. OCREVUS is the number one prescribed MS 
medication in the U.S. for patients starting a new treatment, and more 
than 200,000 people have now been treated with OCREVUS globally. 
 
 
 
   "All patients regardless of their form of MS experience disease 
progression from the start. Therefore, we are encouraged by these new 
analyses showing that early treatment with OCREVUS may significantly 
control disease progression in both relapsing-remitting MS and in 
primary progressive MS. Controlling progression can enable people with 
MS to maintain mobility and limit their disability," said Levi Garraway, 
M.D., Ph.D. Roche's Chief Medical Officer and Head of Global Product 
Development. "In addition, our data show that more people with MS are 
staying on OCREVUS, the only twice-yearly treatment for MS, compared 
with other therapies, which may translate to improved outcomes." 
 
 
 
   Interim analysis Phase IIIb ENSEMBLE: No evidence of disease progression 
in early-stage RRMS 
 
   OCREVUS treatment provided consistent benefit over one year in patients 
who were recently diagnosed with RRMS and had not received prior disease 
modifying treatment (DMT) in an interim analysis of open-label Phase 
IIIb study ENSEMBLE. After 48 weeks, 85% of OCREVUS-treated patients 
achieved no evidence of disease activity (NEDA; no relapses, worsening 
of disability or new or enlarging brain lesions with pre-specified MRI 
re-baselining at 8 weeks). The average annualised relapse rate across 
all patients was very low (0.005) and their mean change in Expanded 
Disability Status Scale score (EDSS) from baseline significantly 
improved from 1.71 to 1.55 (p=0.002). Additionally, neurofilament light 
chain (NfL), a marker of nerve cell damage, was reduced to nearly 
healthy control levels with OCREVUS treatment (10.5 pg/mL at baseline to 
4.55 pg/mL at 48 weeks with OCREVUS vs. 4.12 pg/mL in healthy controls). 
The safety profile of OCREVUS in this trial was consistent with its 
overall favourable safety profile. 
 
 
 
   Post-hoc analysis Phase III ORATORIO: Slowed atrophied T2-lesion 
accumulation in PPMS 
 
   OCREVUS treatment significantly slowed accumulation of atrophied 
T2-lesion volume (aT2-LV) compared with placebo at 120 weeks in a 
post-hoc analysis of the ORATORIO study in PPMS (319 mm3 vs. 366 mm3 
with placebo, p<0.015). AT2-LV is a measure that reflects the volume of 
T2 lesions in brain tissue that is replaced by cerebrospinal fluid, and 
is believed to be a marker of disease progression in MS. People with 
PPMS experience three to five times higher accumulation of aT2-LV than 
people with relapsing MS and these data suggest that OCREVUS may 
favourably impact the underlying progressive biology of MS. 
 
 
 
   Two-year US claims analysis: Highest adherence and persistence rates 
 
   Approximately 80% of patients adhered to twice-yearly (six-monthly) 
dosing of OCREVUS after their second year of treatment compared with 
other DMTs, which were grouped by administration route (35% adherence to 
injectables, 55% to orals and 54% to other infusions), in a new analysis 
of U.S. commercial and insurance claims databases. OCREVUS also had the 
highest proportion of patients (75%) persist with therapy at two years 
(33% with injectables, 54% with orals and 55% with other infusions). 
 
 
 
   With rapidly growing real-world experience and more than 200,000 people 
treated globally, OCREVUS is the first and only therapy approved for 
relapsing MS (RMS; including RRMS and active, or relapsing, secondary 
progressive MS [SPMS], in addition to clinically isolated syndrome [CIS] 
in the U.S.) and PPMS. At Roche, we are constantly striving to optimise 
the care for people with MS and a shorter two-hour OCREVUS infusion time, 
dosed twice yearly (six-monthly), is now approved for eligible people 
with RMS or PPMS in the U.S. and EU. 
 
 
 
   OCREVUS is approved in 95 countries across North America, South America, 
the Middle East, Eastern Europe, as well as in Australia, Switzerland, 
the United Kingdom and the European Union (EU). 
 
 
 
   About multiple sclerosis 
 
   Multiple sclerosis (MS) is a chronic disease that affects up to a 
million people in the U.S. and more than 2.8 million people worldwide. 
MS occurs when the immune system abnormally attacks the insulation and 
support around nerve cells (myelin sheath) in the central nervous system 
(brain, spinal cord and optic nerves), causing inflammation and 
consequent damage. This damage can cause a wide range of symptoms, 
including muscle weakness, fatigue and difficulty seeing, and may 
eventually lead to disability. Most people with MS experience their 
first symptom between 20 and 40 years of age, making the disease the 
leading cause of non-traumatic disability in younger adults. 
 
 
 
   People with all forms of MS experience disease progression -- permanent 
loss of nerve cells in the central nervous system and gradual worsening 
of disability -- at the beginning of their disease even if their 
clinical symptoms aren't apparent or don't appear to be getting worse. 
Delays in diagnosis and treatment can negatively impact people with MS, 
both in terms of their physical, mental and financial health. An 
important goal of treating MS is to slow the progression of disability 
as early as possible. 
 
 
 
   Relapsing-remitting MS (RRMS) is the most common form of the disease and 
is characterised by episodes of new or worsening signs or symptoms 
(relapses) followed by periods of recovery. Approximately 85% of people 
with MS are initially diagnosed with RRMS. The majority of people who 
are diagnosed with RRMS will eventually transition to secondary 
progressive MS (SPMS), in which they experience steadily worsening 
disability over time. Relapsing forms of MS (RMS) include people with 
RRMS and people with SPMS who continue to experience relapses. Primary 
progressive MS (PPMS) is a debilitating form of the disease marked by 
steadily worsening symptoms but typically without distinct relapses or 
periods of remission. Approximately 15% of people with MS are diagnosed 
with the primary progressive form of the disease. Until the FDA approval 
of OCREVUS, there had been no FDA approved treatments for PPMS. 
 
 
 
   About OCREVUS (ocrelizumab) 
 
   OCREVUS is the first and only therapy approved for both RMS (including 
RRMS and active, or relapsing, SPMS) and PPMS, with six-month dosing. 
OCREVUS is a humanized monoclonal antibody designed to 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, suggesting that 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. Our 
goal is to pursue groundbreaking science to develop new treatments that 
help improve the lives of people with chronic and potentially 
devastating diseases. 
 
 
 
   Roche is investigating more than a dozen medicines for neurological 
disorders, including spinal muscular atrophy, multiple sclerosis, 
neuromyelitis optica spectrum disorder, Alzheimer's disease, 
Huntington's disease, Parkinson's disease, Duchenne muscular dystrophy 
and autism spectrum disorder. Together with our partners, we are 
committed to pushing the boundaries of scientific understanding to solve 
some of the most difficult challenges in neuroscience today. 
 
 
 
   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. More than thirty 
medicines developed by Roche are included in the World Health 
Organization Model Lists of Essential Medicines, among them life-saving

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April 16, 2021 01:00 ET (05:00 GMT)