-- 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 
settings. 
 
   "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 
pandemic. 
 
   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 
molecules. 
 
   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

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