Basel, 19 March 2020- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced
we are working with the Food & Drug Administration (FDA) to initiate a
randomised, double-blind, placebo-controlled Phase III clinical trial in
collaboration with the Biomedical Advanced Research and Development
Authority (BARDA), a part of the US Health and Human Services Office of
the Assistant Secretary for Preparedness and Response (ASPR), to
evaluate the safety and efficacy of Actemra(R)/RoActemra(R)
(tocilizumab) plus standard of care in hospitalised adult patients with
severe COVID-19 pneumonia compared to placebo plus standard of care.

This is the first global study of Actemra/RoActemra in this setting and
is expected to begin enrolling as soon as possible in early April with a
target of approximately 330 patients globally, including the US. The
primary and secondary endpoints include clinical status, mortality,
mechanical ventilation and intensive care unit (ICU) variables.

“We are initiating a clinical trial to study Actemra/RoActemra for the
treatment of people hospitalised with COVID-19 pneumonia, so that we can
better establish the potential role for Actemra/RoActemra in fighting
this disease,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical
Officer and Head of Global Product Development. “In these unprecedented
times, today’s announcement is an important example of how industry and
regulators can collaborate quickly to address the COVID-19 pandemic, and
we will share the results as soon as possible.”

To date, there are several independent clinical trials exploring the
efficacy and safety of Actemra/RoActemra for the treatment of patients
with COVID-19 pneumonia. Actemra/RoActemra has been included in the 7th
updated diagnosis and treatment plan for COVID-19 issued by China’s
National Health Commission (NHC) on March 3, 2020.

However, this new trial is vital because there are no well-controlled
studies and limited published evidence on the safety or efficacy of
Actemra/RoActemra in the treatment of patients suffering from COVID-19.
In addition, Actemra/RoActemra is not currently approved for this use by
any health authorities, including the US Food and Drug Administration
(FDA).

In addition to initiating this trial, Roche received FDA Emergency Use
Authorisation for the cobas(R) SARS-CoV-2 Test on March 13, 2020, to
detect the novel virus that causes COVID-19 disease.
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Learn more here.

About the Clinical Trial

Roche is initiating a randomised, double-blind, placebo-controlled Phase
III study (COVACTA) to evaluate the safety and efficacy of intravenous
Actemra/RoActemra added to standard of care in adult patients
hospitalised with severe COVID-19 pneumonia compared to placebo plus
standard of care. The primary and secondary endpoints include clinical
status, mortality, mechanical ventilation and intensive care unit (ICU)
variables. Patients will be followed for 60 days post-randomisation, and
an interim analysis will be conducted to look for early evidence of
efficacy.

About Actemra/RoActemra

Actemra/RoActemra was the first approved anti-IL-6 receptor biologic
available in both intravenous (IV) and subcutaneous (SC) formulations
for the treatment of adult patients with moderate-to-severe active
rheumatoid arthritis (RA). Actemra/RoActemra can be used alone or with
methotrexate (MTX) in adult RA patients who are intolerant to, or have
failed to respond to, other disease-modifying anti-rheumatic drugs
(DMARDs). In Europe, RoActemra IV and SC are also approved for use in
adult patients with severe, active and progressive RA who previously
have not been treated with MTX. Actemra/RoActemra IV and SC are approved
globally for polyarticular juvenile idiopathic arthritis (pJIA) and in
the US and Europe for systemic juvenile idiopathic arthritis (sJIA) in
children two years of age and older. Actemra/RoActemra SC injection is
also the first approved therapy for the treatment of giant cell
arteritis (GCA) in more than 40 countries, including the US and Europe.
In the US and Europe, Actemra/RoActemra IV injection is approved for the
treatment of chimeric antigen receptor (CAR) T-cell-induced severe or
life-threatening cytokine release syndrome (CRS) in people two years of
age and older. Actemra/RoActemra was the first approved treatment for
CRS in this setting. A prefilled autoinjector ACTPen has been approved
in the US and Europe. In Japan, Actemra is also approved for the
treatment of Castleman’s Disease and Takayasu Arteritis.
Actemra/RoActemra is part of a co-development agreement with Chugai
Pharmaceutical Co., Ltd and has been approved in Japan since April 2005.
Actemra/RoActemra is approved in more than 110 countries worldwide.

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
eleventh 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 2019 employed about 98,000 people worldwide. In
2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF
61.5 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
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www.roche.com.