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Press Release: EMA issues advice on casirivimab -2-

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Press Release: EMA issues advice on casirivimab and imdevimab antibody cocktail for the treatment of mild-to-moderate COVID-19

CHMP has completed a review of available data for investigational
antibody cocktail casirivimab and imdevimab (REGN-COV2) to be considered
for the treatment of confirmed COVID-19

CHMP scientific opinion supports national decision making within EU
states on the use of the antibodies before a formal authorisation is
granted during a public health emergency

Roche and Regeneron are collaborating on developing and manufacturing
casirivimab and imdevimab; Roche will be responsible for distribution in
Europe and other countries outside the US

Basel, 26 February 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) confirmed
today that the European Medicines Agency's (EMA) Committee for Medicinal
Products for Human Use (CHMP) has issued a scientific opinion supporting
the use of the investigational antibody cocktail, casirivimab and
imdevimab, as a treatment option for patients with confirmed COVID-19
who do not require oxygen supplementation and who are at high risk of
progressing to severe COVID-19.

The CHMP's scientific opinion (under Article 5(3) of Regulation
726/2004) provides a harmonised, EU-level opinion on the efficacy,
quality and safety of casirivimab and imdevimab. This review took place
in parallel to the EMA's ongoing rolling review process, which is used
to speed up the formal marketing application assessment of a promising
medicine during a public health emergency. Under Article 5(3), the CHMP
assessed available data in patients with COVID-19, including data from
the REGN-COV2 2067 trial, as well as supportive data from other

"This advice by the CHMP regarding casirivimab and imdevimab is an
important step towards addressing the COVID-19 pandemic in the EU," said
Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global
Product Development. "Initial data showed that patients treated with
this investigational antibody cocktail saw a reduction in both viral
loads and medically-attended visits. Together with our partner Regeneron,
we will continue working with the EMA, governments and other health
authorities across the globe to bring this antibody cocktail to as many
patients as possible."

Roche and Regeneron are collaborating to develop, manufacture and
distribute casirivimab and imdevimab, to people around the globe, with
the aim of having more than two million doses available in 2021.
Regeneron will be responsible for distributing the antibody cocktail in
the US and Roche will be responsible for distribution outside the US,
with the first Roche-manufactured doses already being distributed.
Casirivimab and imdevimab could provide a much-needed treatment option
for infected individuals already experiencing symptoms of COVID-19, and
may be able to prevent infection in people exposed to the virus, and
hopefully help slow the spread of the global pandemic.

The investigational antibody cocktail of casirivimab and imdevimab
continues to be evaluated in clinical trials in multiple settings for
COVID-19: in non-hospitalised and certain hospitalised patients,
including the open-label RECOVERY trial of hospitalised patients in the
UK, and a trial for the prevention of COVID-19 in household contacts of
infected individuals. As of February 2021, approximately 23,000 people
have participated in casirivimab and imdevimab clinical trials. Lower
doses of casirivimab and imdevimab are also being studied with the aim
of increasing the number of patients who could potentially be treated if
the cocktail is approved.

In these exceptional times, Roche stands together with society,
governments, healthcare providers and all those working to overcome the

About the CHMP's review under Article 5(3) of Regulation 726/2004

The intent of the Article 5(3) referral procedure is for the CHMP to
develop a harmonised scientific opinion at the EU level on the quality,
safety and efficacy of a medicine based on the currently available data.
The scientific opinions can then be considered by EU member states when
making decisions on the use of medicines at a national level before a
formal authorisation is issued.

The review under Article 5(3) of Regulation 726/2004 was requested by
the EMA's Executive Director following preliminary discussions with the
COVID-19 EMA pandemic task force (COVID-ETF), which brings together
experts from across the European medicines regulatory network to advise
on the development, authorisation and safety monitoring of medicines and
vaccines for COVID-19.

About casirivimab and imdevimab

Casirivimab and imdevimab is a cocktail of two monoclonal antibodies
(also known as REGN10933 and REGN10987, respectively) and was designed
by Regeneron scientists to block infectivity of SARS-CoV-2, the virus
that causes COVID-19. They evaluated thousands of fully-human antibodies
produced by the company's proprietary VelocImmune(R) mice, which have
been genetically modified to have a human immune system, as well as
antibodies identified from humans who have recovered from COVID-19.

The two potent, virus-neutralising antibodies that form casirivimab and
imdevimab are believed to bind non-competitively to the critical
receptor binding domain of the virus's spike protein, which is
hypothesised to diminish the ability of mutant viruses to escape
treatment and to protect against spike variants that may arise in the
human population, as detailed in recent Science publications.

Casirivimab and imdevimab have not been approved by any health
authority. In November 2020, the antibody cocktail was authorised by the
U.S. Food and Drug Administration (FDA) under an Emergency Use
Authorization (EUA) for the treatment of mild to moderate COVID-19 in
adults and paediatric patients (12 years of age and older weighing at
least 40 kg) with positive results of direct SARS-CoV-2 viral testing,
and who are at high risk for progressing to severe COVID-19 and/or
hospitalisation. The US EUA is temporary and does not take the place of
the formal biologics license application (BLA) submission, review and
approval process.

Casirivimab and imdevimab's development, manufacturing and clinical
trials have been funded in part by the Biomedical Advanced Research and
Development Authority (BARDA), part of the Office of the Assistant
Secretary for Preparedness and Response at the U.S. Department of Health
and Human Services under OT number: HHSO100201700020C.

About Roche's response to the COVID-19 pandemic

As a leading healthcare company we are doing all we can to support
countries in minimising the impact of COVID-19. We have developed a
growing number of diagnostic solutions that help to detect and diagnose
the infection in patients, as well as providing digital support to
healthcare systems, and we continue to identify, develop and support
potential therapies which can play a role in treating the disease.

We understand the impact of COVID-19 goes beyond those who contract it,
which is why we are working with healthcare providers, laboratories,
authorities and organisations to help make sure that patients continue
to receive the tests, treatment and care they need during these
challenging times. As we learn from the pandemic, we are partnering with
governments and others to make healthcare stronger and more sustainable
in the future.

Our diagnostics solutions:

Reliable, high-quality testing is essential to help healthcare systems
overcome this pandemic. Our portfolio includes:

a high-volume molecular test to detect SARS-CoV-2, the virus that causes
COVID-19, (FDA Emergency Use Authorisation (EUA) and available in
countries accepting the CE Mark)

a SARS-CoV-2 laboratory-based antibody test, aimed at detecting the
presence of antibodies in the blood targeting the nucleocapsid (FDA EUA
and CE Mark)

an IL-6 test to assist in identifying severe inflammatory response in
patients with confirmed COVID-19 (FDA EUA and CE Mark)

Roche v-TAC, which could help simplify the screening, diagnosis and
monitoring of patients with respiratory compromise in the current
COVID-19 pandemic

a SARS-CoV-2 rapid antibody test to help determine at the point of care
whether a person has been exposed to the virus (CE Mark)

a rapid antigen test to support in the detection of SARS-CoV-2 at the
point of care within 15 minutes (CE Mark)

a high-volume molecular test to simultaneously detect and differentiate
between SARS-CoV-2 and influenza A/B, as the symptoms are similar for
both (FDA EUA and CE Mark)

a second SARS-CoV-2 antibody test, aimed at measuring the spike protein
to support vaccination development and complement our existing portfolio

a point-of-care molecular PCR test that simultaneously detects and
differentiates between SARS-CoV-2 and influenza A/B infections to support
urgent triage and diagnosis (FDA EUA and CE Mark)

Our research into therapies:

Roche is committed to improving the treatment of COVID-19. We are
actively involved in understanding the potential of our existing
portfolio and are exploring the potential of our investigational

There have been/are a number of clinical trials with an external 3rd
party as the sponsor exploring the efficacy and safety of Actemra
(tocilizumab) for the treatment of COVID-19 associated pneumonia.
COVACTA and EMPACTA, sponsored by Roche, are the first global phase III,
multi-centre, randomised, placebo-controlled studies evaluating Actemra
in this setting.

We continue to evaluate the data from the global COVACTA study, which
did not meet its primary endpoint as announced on 29 July 2020, in
conjunction with results from the global EMPACTA study of Actemra in
COVID-19 pneumonia, which met its primary endpoint as announced on 17
September 2020, as well as additional data sources that are in the

(MORE TO FOLLOW) Dow Jones Newswires

February 26, 2021 07:12 ET ( 12:12 GMT)

public domain to determine whether a population can be defined based on
patient and disease characteristics in which Actemra on top of usual
care may provide a favourable benefit risk profile.

Roche remains committed to continuing the Actemra clinical trial
programme in COVID-19 to further explore Actemra in other treatment
settings, including in combination with an antiviral.

In August 2020 we signed a collaboration agreement with Regeneron on
developing, manufacturing and significantly increasing global supply of
an investigational antibody cocktail for COVID-19 if it proves safe and
effective in clinical trials and regulatory approvals are granted.

In October 2020 we signed an agreement with Atea to jointly develop
AT-527, an orally administered direct-acting antiviral (DAA) currently
in phase II clinical trials. AT-527 has the potential to be the first
novel oral antiviral to treat COVID-19 patients outside the hospital
setting, as well as in the hospital, and may also be used in
post-exposure prophylactic settings.

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.

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

Dr. Nicolas Dunant Patrick Barth
Phone: +41 61 687 05 17 Phone: +41 61 688 44 86

Dr. Daniel Grotzky Karsten Kleine
Phone: +41 61 688 31 10 Phone: +41 61 682 28 31

Nina Mählitz Nathalie Meetz
Phone: +41 79 327 54 74 Phone: +41 61 687 43 05

Dr. Barbara von Schnurbein
Phone: +41 61 687 89 67

Roche Investor Relations

Dr. Karl Mahler Jon Kaspar Bayard
Phone: +41 61 68-78503 Phone: +41 61 68-83894
e-mail: karl.mahler@roche.com e-mail: jon_kaspar.bayard@roche.com

Dr. Sabine Borngräber Dr. Bruno Eschli
Phone: +41 61 68-88027 Phone: +41 61 68-75284
e-mail: sabine.borngraeber@roche.com e-mail: bruno.eschli@roche.com

Dr. Birgit Masjost Dr. Gerard Tobin
Phone: +41 61 68-84814 Phone: +41 61 68-72942
e-mail: birgit.masjost@roche.com e-mail: gerard.tobin@roche.com

Investor Relations North America
Loren Kalm Dr. Lisa Tuomi
Phone: +1 650 225 3217 Phone: +1 650 467 8737
e-mail: kalm.loren@gene.com e-mail: tuomi.lisa@gene.com


26022021_MR_EMA CHMP review casirivimab and imdevimab_en

(END) Dow Jones Newswires

February 26, 2021 07:12 ET ( 12:12 GMT)

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