- 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 andRoche will be responsible for distribution outside the US
Under the new agreement, the US government will purchase up to 1.25 million finished doses of casirivimab and imdevimab by
“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
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
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® 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
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)
·
· 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:
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
We continue to evaluate the data from the global COVACTA study, which did not meet its primary endpoint as announced on
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Attachment
- 12012021_MR_BARDA supply agreement
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