-- If approved, ENSPRYNG will be the first and only treatment available to 
      both adults and adolescents from 12 years of age with anti-aquaporin-4 
      antibody (AQP4-IgG) seropositive NMOSD in the EU 
 
   -- ENSPRYNG is the only subcutaneous treatment option for NMOSD that can be 
      administered at home every four weeks 
 
   -- Recommendation is based on results from the two pivotal Phase III 
      SAkuraStar and SAkuraSky studies, in which ENSPRYNG demonstrated robust 
      and sustained efficacy in reducing the risk of relapse and a favourable 
      safety profile 
 
   -- NMOSD is a rare, lifelong and debilitating autoimmune disorder of the 
      central nervous system that can cause blindness, muscle weakness and 
      paralysis 
 
   Basel, 23 April 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced 
today that the European Medicines Agency's (EMA) Committee for Medicinal 
Products for Human Use (CHMP) has recommended the approval of 
ENSPRYNG(R) (satralizumab) as the first subcutaneous treatment option 
for adults and adolescents from 12 years of age living with 
anti-aquaporin-4 antibody (AQP4-IgG) seropositive neuromyelitis optica 
spectrum disorder (NMOSD), as a monotherapy or in combination with 
immunosuppressive therapy (IST). AQP4-IgG are present in around 70-80% 
of people with NMOSD, who tend to experience a more severe disease 
course. 
 
   NMOSD is a rare, lifelong and debilitating autoimmune disorder of the 
central nervous system, often misdiagnosed as multiple sclerosis, that 
primarily damages the optic nerve(s) and spinal cord, causing permanent 
blindness, muscle weakness and paralysis. The disease is characterised 
by unpredictable relapses and severe disability often occurs following 
the first NMOSD attack, accumulating with each subsequent relapse. 
Preventing these relapses is the primary goal for disease management. 
ENSPRYNG has been recommended for use in people who have only 
experienced a single NMOSD attack and adolescents, currently unserved 
NMOSD populations, as well as those with more advanced disease. 
 
   "Today's positive CHMP opinion is an important step toward bringing 
ENSPRYNG to people in the EU living with NMOSD who have limited 
treatment options," said Levi Garraway, M.D., Ph.D., Chief Medical 
Officer and Head of Global Product Development. "ENSPRYNG has been shown 
to reduce the risk of relapse significantly, while also offering a 
favourable safety profile. Additionally, if approved, ENSPRYNG would be 
the first and only treatment that can be self-administered 
subcutaneously at home following appropriate training." 
 
   ENSPRYNG is a humanised monoclonal antibody designed to target and 
inhibit interleukin-6 (IL-6) receptor activity, believed to play a key 
role in the inflammation associated with NMOSD. The treatment was 
designed by Chugai, a member of the Roche Group, using novel recycling 
antibody technology which, compared to conventional technology, allows 
for longer duration of antibody circulation and subcutaneous dosing 
every four weeks after an initial loading dose. 
 
   The CHMP recommendation is based on the results of the Phase III 
SAkuraStar and SAkuraSky studies in which ENSPRYNG showed robust and 
sustained efficacy results in reducing the risk of relapse and a 
favourable safety profile in people with AQP4-IgG seropositive NMOSD. A 
final decision regarding the approval is expected from the European 
Commission in the near future. 
 
   About SAkuraStar and SAkuraSky in NMOSD 
 
   SAkuraStar was a pivotal Phase III study evaluating the efficacy and 
safety of ENSPRYNG monotherapy administered to adults with neuromyelitis 
optica spectrum disorder (NMOSD). In the anti-aquaporin-4 antibody 
(AQP4-IgG) seropositive subgroup, 83% treated with ENSPRYNG remained 
relapse free at 48 weeks, compared with 55% of those treated with 
placebo. At 96 weeks, 77% of those treated with ENSPRYNG remained 
relapse free, compared with 41% with placebo. 
 
   SAkuraSky was a pivotal Phase III study evaluating the efficacy and 
safety of ENSPRYNG in combination with baseline immunosuppressive 
therapy in adults and adolescents with NMOSD. Overall, 92% of 
AQP4-seropositive participants receiving ENSPRYNG in combination with 
immunosuppressants remained relapse free at 48 and 96 weeks, compared 
with 60% and 53% with placebo at 48 and 96 weeks. 
 
   The primary endpoint of both the SAkuraStar and SAkuraSky studies was 
time to first protocol-defined relapse (PDR) adjudicated by an 
independent review committee in the double-blind period. 
 
   ENSPRYNG demonstrated a favourable safety and tolerability profile in 
the Phase III studies. 
 
   The most common adverse reactions observed in the safety population 
were: headache, arthralgia, white blood cell count decrease, 
hyperlipidaemia and injection-related reactions. 
 
   About neuromyelitis optica spectrum disorder (NMOSD) 
 
   NMOSD is a rare, lifelong and debilitating autoimmune condition of the 
central nervous system that primarily damages the optic nerve(s) and 
spinal cord, causing permanent blindness, muscle weakness and paralysis. 
People with NMOSD experience unpredictable, severe relapses directly 
causing cumulative, permanent, neurological damage and disability. In 
some cases, relapse can result in death. NMOSD affects over 10,000 
people in Europe, up to 15,000 people in the US and approximately 
200,000 people worldwide. NMOSD can affect individuals of any age, race 
and gender, but is most common among women in their 30s and 40s, and 
appears to occur at higher rates in people of African or Asian 
background. There is some evidence that people of African or Asian 
descent may also experience a more severe disease course. 
 
   NMOSD is commonly associated with pathogenic antibodies (AQP4-IgG) that 
target and damage a specific cell type, called astrocytes, resulting in 
inflammatory lesions of the optic nerve(s), spinal cord and brain. 
AQP4-IgG antibodies are detectable in the blood serum of around 70-80% 
of people with NMOSD. 
 
   Although most cases of NMOSD can be confirmed through diagnostic tests, 
people living with the condition are still frequently misdiagnosed with 
multiple sclerosis. This is due to overlapping characteristics of the 
two disorders, including a higher prevalence in women, similar symptoms 
and the fact that people can experience relapses in both conditions. 
 
   About ENSPRYNG(R) (satralizumab) 
 
   ENSPRYNG, which was designed by Chugai, a member of the Roche Group, is 
a humanised monoclonal antibody that targets interleukin-6 (IL-6) 
receptor activity. The cytokine IL-6 is believed to be a key driver in 
NMOSD, triggering the inflammation cascade and leading to damage and 
disability. ENSPRYNG was designed using novel recycling antibody 
technology which, compared to conventional technology, allows for longer 
duration of the antibody and subcutaneous dosing every four weeks. 
 
   Positive Phase III results for ENSPRYNG, as both monotherapy and in 
combination with baseline immunosuppressive therapy, suggest that IL-6 
inhibition is an effective therapeutic approach for NMOSD. The Phase III 
clinical development programme for ENSPRYNG includes two studies: 
SAkuraStar and SAkuraSky. 
 
   ENSPRYNG is currently approved in 20 countries, including the United 
States, Canada, Japan and Switzerland. Applications are under review 
with numerous regulators. 
 
   ENSPRYNG has been designated as an orphan drug in the U.S., Europe and 
Japan. In addition, it was granted Breakthrough Therapy Designation for 
the treatment of NMOSD by the FDA in December 2018. 
 
   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 multiple sclerosis, 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.that 
 
   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 
antibiotics, antimalarials and cancer medicines. Moreover, for the 
twelfth consecutive year, Roche has been recognised as one of the most 
sustainable companies 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 2020 employed more than 100,000 people worldwide. 
In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 
58.3 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.

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