-- New agreement covers 1.25 million additional doses of the antibody 
      cocktail, bringing the total potential US supply to over 1.5 million 
      doses 
 
   -- Casirivimab and imdevimab were granted U.S. FDA Emergency Use 
      Authorization for recently-diagnosed, high-risk, mild to moderate 
      COVID-19 patients 
 
   -- Roche and Regeneron are collaborating on developing and manufacturing 
      casirivimab and imdevimab; Regeneron is distributing the antibody 
      cocktail in the US and Roche will be responsible for distribution outside 
      the US 
 
   Basel, 12 January 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today 
confirmed that the U.S. Department of Health and Human Services (HHS) 
and the Department of Defense (DOD) will purchase additional supply of 
Regeneron's casirivimab and imdevimab antibody cocktail for use in 
non-hospitalised COVID-19 patients as part of Operation Warp Speed. The 
US government said it will provide these additional doses at no cost to 
patients, though healthcare facilities may charge fees related to 
administration, and will continue to coordinate allocation of the 
antibody cocktail to state and territorial health departments. 
 
 
 
   Under the new agreement, the US government will purchase up to 1.25 
million finished doses of casirivimab and imdevimab by 30 June 2021. 
Regeneron is already supplying doses to treat approximately 300,000 
people, bringing the total potential purchase to over 1.5 million doses 
in the US. 
 
 
 
   "We are doing all we can to lessen the impact of the ongoing COVID-19 
pandemic, and we remain committed to collaborating with Regeneron to 
increase supply of their antibody cocktail," said Bill Anderson, Chief 
Executive Officer of Roche Pharmaceuticals. "Casirivimab and imdevimab 
will be critically important to help address the pandemic if approved, 
and we will continue to work with regulators and governments across the 
globe to bring the medicine to as many people as possible." 
 
 
 
   The efficacy and safety of casirivimab and imdevimab continue to be 
evaluated in clinical trials for the treatment of COVID-19 in certain 
hospitalised and non-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. 
Lower doses of casirivimab and imdevimab are also being studied with the 
aim of increasing supply and offering the therapy to more patients. To 
date, nearly 15,000 people have participated in casirivimab and 
imdevimab clinical trials. 
 
 
 
   Roche is collaborating with Regeneron to increase global supply of 
casirivimab and imdevimab, with the aim of having more than 2 million 
treatment doses available annually. Regeneron is responsible for the 
development and distribution of the treatment in the US, and Roche is 
primarily responsible for the development and distribution outside the 
US. Roche is actively working with governments outside of the US on 
potential supply agreements. The companies share a commitment to making 
the antibody cocktail available to COVID-19 patients around the globe if 
approved and will support access in low- and lower-middle-income 
countries through drug donations to be made in partnership with public 
health organisations. 
 
 
 
   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'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 Emergency Use Authorization status 
 
   Casirivimab and imdevimab have not been FDA cleared or approved. They 
have 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. -- 360bbb- 
3(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 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 
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.

(MORE TO FOLLOW) Dow Jones Newswires

January 12, 2021 17:55 ET (22:55 GMT)