Regeneron and its partner Roche have new phase III clinical data to show that they can treat sick patients and protect people who have not been vaccinated.
Some analysts estimate that if approved by regulatory agencies, the antibody cocktail therapy REGEN-C0V in the hands of these two companies will become a blockbuster product.
REGEN-COV consists of two monoclonal antibodies casirivimab and imdevimab.
According to the announcement issued by both parties, REGEN-COV reduces the risk of hospitalization or death of high-risk non-hospital patients by 70% compared with placebo.
Importantly, REGEN-COV also retains its effectiveness against five major COVID-19 variants, including those originating from South Africa, the United Kingdom, and New York.
In addition, REGEN-COV is effective in 3 different doses.
In November 2020, REGEN-COV was granted an emergency use authorization (EUA) by the US FDA.
The agency said that this is currently the only antibody therapy that can be used against new variants.
With the support of the new data released this time, the Regeneron Program requested the FDA to update its guidance to include the minimum dose of 1200mg tested in the phase 3 clinical trial.
But REGEN-COV also faces competition from Eli Lilly's antibody cocktail.
In another phase 3 clinical trial, Eli Lilly's antibody cocktail therapy consisting of two monoclonal antibodies bamlanivimab and etesevimab treated high-risk patients at an early stage of infection, reducing the risk of hospitalization and death by 87%.
Previously, the antibody cocktail therapy has also been granted EUA by the US FDA for the treatment of high-risk patients.
Roche and Regeneron emphasized the relevance of the latest clinical trial results to protect high-risk populations from COVID-19 and emerging virus variants.
All patients enrolled in this phase 3 clinical trial have at least one risk factor that may lead to serious complications of the virus.
For example, nearly 60% of patients are obese, while more than half of patients are over 50 years old, and 36% of patients have cardiovascular disease.
An investigator of the trial, Suraj Saggar, director of infectious diseases at the Holy Name Medical Center in Teaneck, New Jersey, said in a statement, “Because there are still so many people infected, and recent data show that REGEN-COV is treating The ability of new variants, these data emphasize the need to quickly adopt REGEN-COV as the standard of care to provide high-risk patients with the best opportunity to reduce serious consequences such as hospitalization or death.
Regeneron said that the company expects REGEN-COV to reach US$260 million in sales in the US market in the first quarter of this year.
US investment bank SVB Leerink analysts issued a report to clients on Tuesday, estimating that the sales of this antibody cocktail therapy in the second quarter may reach 2.
6 billion US dollars.
International authoritative rating agency Morningstar analyst Karen Andersen said last fall that REGEN-COV may achieve sales of $6 billion in 2021.
This figure is her expected peak sales of Gilead’s antiviral drug remdesivir (remdesivir).
In the cooperation between Regeneron and Roche, Regeneron is responsible for the development and commercialization of the US market, while Roche is responsible for markets outside the US.
Currently, the European Medicines Agency (EMA) is conducting a rolling review of this antibody cocktail, but the agency said in February that this drug can be used to treat high-risk patients who have progressed to severe COVID-19 before the review is completed.
Roche said in a statement that data from the Phase 3 clinical trial is shared with regulatory authorities around the world.
However, given that the supply of vaccines will increase significantly in the next few months, is there still a need for COVID-19 treatments globally? Dr.
Levi Garraway, Roche's chief medical officer and head of global product development, pointed out that there were 3 million new cases of COVID-19 reported worldwide last week.
Therefore, antibody cocktails can find a market, "especially in light of recent evidence that REGEN-COV retains activity against major emerging variants.
Currently, other clinical trials of REGEN-COV are being conducted around the world, including a Phase 3 trial for the treatment of hospitalized COVID-19 patients in the UK, and a preventive trial in the family members of COVID-19 patients to test REGEN- The therapeutic and protective effects of COV.
Reference source: Regeneron, Roche COVID-19 antibody cocktail slashes hospitalizations and tackles variants in phase 3Reference source: Regeneron, Roche COVID-19 antibody cocktail slashes hospitalizations and tackles variants in phase 3