* OCREVUS subcutaneous (SC) injection offers a new, 10-minute administration

    of OCREVUS with comparable efficacy and safety to intravenous infusion (IV)
  * OCREVUS SC provides an additional treatment option without the need for IV
    facilities, expanding accessibility for patients
  * Roche is working closely with national health systems in Europe to ensure
    people with multiple sclerosis can access OCREVUS SC as quickly as possible

Basel, 25 June 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that
the European Commission has granted marketing authorisation for OCREVUS®
(ocrelizumab) subcutaneous (SC) for the treatment of relapsing multiple
sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). OCREVUS SC is
a 10-minute injection that maintains the same twice-yearly schedule as the
previously approved intravenous (IV) infusion. More than 350,000 people with
multiple sclerosis have been treated with OCREVUS IV globally.
"OCREVUS transformed the way multiple sclerosis is treated as the first anti-
CD20 therapy approved in this disease. Now, people in the EU with multiple
sclerosis can have their medicine administered in just 10 minutes twice per year
without needing an IV facility," said Levi Garraway, M.D., Ph.D., Roche's Chief
Medical Officer and Head of Global Product Development. "This makes it easier
for more people with multiple sclerosis to access their treatment, while also
saving time for providers."
The approval is based on pivotal data from the Phase III OCARINA II trial, which
showed non-inferior levels of OCREVUS in the blood, when administered
subcutaneously, and a safety and efficacy profile comparable to the IV
formulation in patients with RMS and PPMS. OCREVUS SC was well tolerated and no
new safety concerns were identified. More than 92% of patients who were surveyed
as part of the study reported being satisfied or very satisfied with the SC
administration of OCREVUS.
OCREVUS SC was developed to provide an alternative twice-a-year treatment
option, in addition to IV, so that the administration of OCREVUS can be matched
to the individual needs of patients and healthcare professionals (HCPs). The SC
injection was designed to be HCP administered, with the flexibility to
administer either in the clinic or in settings outside the clinic. Roche is
committed to advancing innovative clinical research programmes to broaden the
scientific understanding of multiple sclerosis, further reduce disability
progression in RMS and PPMS and improve the treatment experiences for those
living with multiple sclerosis.
About OCREVUS SC
OCREVUS SC combines OCREVUS with Halozyme Therapeutics' ENHANZE® drug delivery
technology.
OCREVUS is a humanised 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. 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.
The ENHANZE® drug delivery technology is based on a proprietary recombinant
human hyaluronidase PH20 (rHuPH20), an enzyme that locally and temporarily
degrades hyaluronan - a glycosaminoglycan or chain of natural sugars in the body
- in the subcutaneous space. This increases the permeability of the tissue under
the skin, allowing space for OCREVUS to enter, and enabling it to be rapidly
dispersed and absorbed into the bloodstream.
OCREVUS is the first and only therapy approved for both RMS (including
relapsing-remitting multiple sclerosis (RRMS) and active, or relapsing secondary
progressive multiple sclerosis (SPMS), as well as clinically isolated syndrome
(CIS) in the U.S.) and PPMS.
About the OCARINA II study
OCARINA II (NCT05232825) was a Phase III, global, multicentre, randomised study
that evaluated the pharmacokinetics, safety and clinical and radiological
efficacy of the subcutaneous (SC) formulation of OCREVUS compared with OCREVUS
intravenous (IV) infusion in 236 patients with relapsing multiple sclerosis
(RMS) or primary progressive multiple sclerosis (PPMS).
The trial met its primary and secondary endpoints, demonstrating SC injection
was non-inferior to IV infusion based on OCREVUS levels in the blood, and
comparable control of clinical (relapses) and radiological (MRI lesions) disease
activity. The safety profile of OCREVUS SC was also consistent with the well-
established safety profile of OCREVUS IV.
About multiple sclerosis
Multiple sclerosis is a chronic disease that affects more than 2.9 million
people worldwide. Multiple sclerosis 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 weakness, fatigue and difficulty seeing, and may eventually
lead to disability. Most people with multiple sclerosis 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 multiple sclerosis experience disease progression -
permanent loss of nerve cells in the central nervous system - from the beginning
of their disease even if their symptoms aren't apparent or don't appear to be
getting worse. Delays in diagnosis and treatment can negatively impact people
with multiple sclerosis, in terms of their physical and mental health, and
contribute to the negative financial impact on the individual and society. An
important goal of treating multiple sclerosis is to slow, stop and ideally
prevent progression as early as possible.
Relapsing-remitting multiple sclerosis (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
multiple sclerosis are initially diagnosed with RRMS. The majority of people who
are diagnosed with RRMS will eventually transition to secondary progressive
multiple sclerosis (SPMS), in which they experience steadily worsening
disability over time. Relapsing forms of multiple sclerosis (RMS) include people
with RRMS and people with SPMS who continue to experience relapses. Primary
progressive multiple sclerosis (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 multiple sclerosis 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 and
OCREVUS is still the only approved treatment for PPMS.
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 neuromuscular diseases: Duchenne muscular dystrophy,
facioscapulohumeral muscular dystrophy and spinal muscular atrophy; neuro immune
diseases: multiple sclerosis and neuromyelitis optica spectrum disorder; and
neurodegenerative diseases: Alzheimer's disease, Huntington's disease and
Parkinson's disease. 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
Founded in 1896 in Basel, Switzerland, as one of the first industrial
manufacturers of branded medicines, Roche has grown into the world's largest
biotechnology company and the global leader in in-vitro diagnostics. The company
pursues scientific excellence to discover and develop medicines and diagnostics
for improving and saving the lives of people around the world. We are a pioneer
in personalised healthcare and want to further transform how healthcare is
delivered to have an even greater impact. To provide the best care for each
person we partner with many stakeholders and combine our strengths in
Diagnostics and Pharma with data insights from the clinical practice.
In recognising our endeavour to pursue a long-term perspective in all we do,
Roche has been named one of the most sustainable companies in the
pharmaceuticals industry by the Dow Jones Sustainability Indices for the
fifteenth consecutive year. This distinction also reflects our efforts to
improve access to healthcare together with local partners in every country we
work.
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 (http://www.roche.com).
All trademarks used or mentioned in this release are protected by law.
Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com
(mailto:media.relations@roche.com)

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