RT-qPCR test and a negative antibody test) at randomization 
 
   Adverse events (AEs) occurred in 34% (n=52 out of 155) of REGEN-COV 
patients and 48% (n=75 out of 156) of placebo patients, and serious AEs 
occurred in 0% (n=0) of REGEN-COV patients and 3% (n=4) of placebo 
patients. Injection site reactions, all of which were grades 1-2, 
occurred in 4% (n=6) of REGEN-COV patients and 1% (n=1) of placebo 
patients. No patients from either group withdrew from the trial due to 
AEs, and there were no deaths. 
 
 
 
   About REGN-COV 2069 
 
   REGN-COV 2069 is a phase III, randomised, double-blind, 
placebo-controlled multi-part study assessing the efficacy and safety of 
casirivimab and imdevimab in preventing symptomatic infection in 
household contacts of individuals infected with COVID-19. 
 
 
 
   In January 2021, initial data from the trial showed that there was a 
reduction in overall infections seen with casirivimab and imdevimab 
within the first week, with approximately 50% lower overall rates of 
infection (symptomatic and asymptomatic) and 100% prevention of 
symptomatic infections. Casirivimab and imdevimab showed efficacy when 
administered via a low-dose (1,200 mg) subcutaneous route. 
 
 
 
   In the safety assessment of these patients, adverse events occurred more 
frequently in participants on placebo during the efficacy analysis 
period (12% in the casirivimab and imdevimab group and 18% in the 
placebo group) and during the follow-up period (11% in the casirivimab 
and imdevimab group and 20% in the placebo group). 
 
 
 
   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 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 
Science publications. 
 
 
 
   The cocktail of casirivimab and imdevimab has not been granted a 
marketing authorisation by any health authority. In November 2020, the 
antibody cocktail was authorised by the United States (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. 
 
 
 
   In February 2021, the European Medicines Agency's (EMA) Committee for 
Medicinal Products for Human Use (CHMP) issued a scientific opinion 
under Article 5(3) of Regulation 726/2004 supporting the use of 
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 scientific opinion 
can 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) was separate, but ran in parallel 
to the rolling review of casirivimab and imdevimab, which is currently 
ongoing by the EMA. 
 
 
 
   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 US Department of Health 
and Human Services under OT number: HHSO100201700020C. 
 
   About U.S. FDA EUA status 
 
   Casirivimab and imdevimab have not been Food and Drug Administration 
(FDA) cleared or approved in the United States (US). It has been 
authorised by the FDA under an Emergency Use Authorization (EUA) during 
the current public health emergency 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. Please see the Fact Sheet for 
Healthcare Providers for more information, including important safety 
information. The cocktail is only authorised for the duration of the 
declaration that circumstances exist justifying the authorisation of the 
emergency use under section 564(b)(1) of the Act, 21 U.S.C. -- 
360bbb3(b)(1), unless the declaration is terminated or authorisation 
revoked sooner. 
 
 
 
   About Roche's response to the COVID-19 pandemic 
 
   As a leading healthcare company we are doing all we can to support 
countries in their fight against COVID-19 and minimising its impact. We 
have developed a growing number of diagnostic solutions that help to 
detect and diagnose the infection, as well as providing digital support 
to healthcare systems. We also continue to identify, develop and support 
potential therapies which can play a role in treating the disease. 
 
 
 
   The impact of COVID-19 goes beyond those who contract it. That is why we 
are working with healthcare providers, laboratories, authorities and 
organisations to help make sure patients continue to receive the tests, 
treatment and care they need during these challenging times.  Building 
on a longstanding tradition of partnerships, we are working together 
with governments and others to make healthcare stronger and more 
sustainable in the future. 
 
 
 
   Reliable, high-quality testing is essential to help healthcare systems 
overcome this pandemic and Roche has so far launched 16 diagnostics 
solutions to help minimise the impact of COVID-19. As soon as the novel 
SARS-CoV-2 virus was sequenced in early 2020, we got to work. On 13 
March 2020 we became the first company to receive U.S. Food and Drug 
Administration (FDA) Emergency Use Authorization (EUA) for a high-volume 
molecular test to detect the virus. Since then, we have continued to add 
a range of diagnostics solutions to our global portfolio to help in the 
fight against COVID-19. In addition to the gold standard PCR test, we 
have developed antigen tests to help diagnose the virus in settings 
where there is limited molecular laboratory infrastructure, rapid 
antigen where the virus can be detected on the spot, tests that can test 
for both flu and COVID-19 at the same time, both high throughput and at 
the point of care, and tests that can detect virus antibodies that can 
help monitor the spread of the virus and can also support in vaccine 
development. On 16 March 2021 the SARS-CoV-2 variant test was launched, 
designed to detect key spike mutations. 
 
 
 
   Aside from these tests we have also looked at how we can support care 
for patients who have COVID-19, receiving an FDA EUA for the Elecsys(R) 
IL-6 test to assist in identifying severe inflammatory response in 
patients with confirmed COVID-19, as well as launching Roche v-TAC, a 
digital algorithm that could help simplify the screening, diagnosis and 
monitoring of respiratory-compromised patients with COVID-19. Roche is 
working closely with governments and health authorities around the world, 
and has significantly increased production to support availability of 
tests globally. 
 
 
 
   Roche is actively involved in understanding the potential of the 
existing portfolio and is researching options for the future. In 2020, 
Roche entered into a number of new partnerships, including with Gilead, 
Regeneron and Atea, to develop, manufacture and distribute molecules 
that can potentially both treat and prevent COVID-19. 
 
 
 
   In October, Roche announced a partnership with Atea Pharmaceuticals to 
jointly develop the investigational compound AT-527. If approved, Atea 
will distribute AT-527 in the United States (US) and Roche will be 
responsible for global manufacturing and distribution outside the US. 
Atea's compound has the potential to be the first oral antiviral to 
treat COVID-19 patients outside the hospital setting as well as in the 
hospital. Its anticipated formulation (pill) could allow for large-scale 
manufacturing and may help to facilitate access to a broad patient 
population. 
 
 
 
   In November, our partner Regeneron received FDA EUA for casirivimab and 
imdevimab, its investigational antiviral antibody combination, for the 
treatment of recently diagnosed patients with mild to moderate COVID-19 
who are at high risk of progressing to severe COVID-19 and/or 
hospitalisation. The antibody cocktail is currently being studied in two 
phase I-III adaptive clinical trials for the treatment of COVID-19 and 
in a phase III trial for the prevention of the disease. As part of the 
global partnership with Regeneron, we are committing a significant 
amount of manufacturing capacity and are working to expand supply of 
this antibody combination beyond the US to as many people as possible. 
 
 
 
   In addition, we are exploring the potential of our investigational 
molecules and existing portfolio: For example, Roche has initiated three 
global phase III clinical trials investigating the safety and efficacy 
of Actemra/RoActemra in COVID-19 associated pneumonia (COVACTA, EMPACTA 
and REMDACTA). Following initial interactions with health authorities, 
Roche will continue to monitor the evolving clinical evidence for 
Actemra/RoActemra in this setting. 
 
 
 
   About Roche

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April 12, 2021 01:00 ET (05:00 GMT)