Factbox-Front runners in development of antibody drugs against COVID-19

FILE PHOTO: A company logo is seen at the AstraZeneca site in Macclesfield, Britain, May 11, 2021. REUTERS/Phil Noble

(Reuters) - AstraZeneca, Eli Lilly, Regeneron and GlaxoSmithKline are among the biggest pharmaceutical companies to have developed COVID-19 treatments using a class of drugs called monoclonal antibodies.

Laboratory-made monoclonal antibodies mimic natural antibodies in fighting off infections. Unlike vaccines, they do not rely on the body to create an immune response, and can therefore help individuals with weak or compromised immune systems.

Below is an outline of where the major drugmakers are in the development and regulatory process:

ASTRAZENECA

* AstraZeneca's antibody cocktail AZD7442 is delivered by intramuscular shot.

* On Oct. 5 the company requested emergency use approval (EUA) from U.S. regulators for the therapy, as a preventative drug.

* On Oct. 14, the EU drug regulator said it had started a real-time review of the treatment.

TRIALS:

* In June, AstraZeneca said a late-stage trial had not showed the therapy could stop individuals exposed to the virus from contracting it.

* In August, another trial showed it reduced the risk of people developing any COVID-19 symptoms by 77%.

* On Oct. 11, data showed AZD7442 reduced the risk of severe COVID-19 or death by 50% in non-hospitalised patients who have had symptoms for seven days or less.

SUPPLY DEALS:

* AstraZeneca said in March it would supply up to 500,000 more doses of the therapy to the United States, extending a prior agreement. The deal is contingent on an EUA from the FDA.

* Britain also has an in-principle agreement for over a million doses.

ELI LILLY & CO

* The U.S. pharmaceutical group's treatment, a combination of the antibodies bamlanivimab and etesevimab, is meant for patients with mild-to-moderate COVID-19.

* It so far given by infusion, or drip, only.

* In February it was granted an EUA by the FDA for treatment of patients at high risk of severe illness who have not been hospitalised or require oxygen therapy.

* The U.S. Department of Health and Human Services paused distribution in June after the drug failed to show effectiveness against several COVID-19 variants, but resumed it for some states at the end of August.

* In September, the FDA revised its EUA to include use in at-risk patients who have been exposed to the virus.

* In late October, Eli Lilly withdrew its request for EU authorisation, saying lack of demand in the bloc did not justify submitting further data.

TRIALS:

* The combination helped cut risk of hospitalisation and death in patients by 70%, early data from a late-stage trial showed in January.

* January data from a trial of one of the therapy's components, bamlanivimab, showed it could cut the risk of infection by 80% for nursing home residents.

SUPPLY DEALS:

* Eli Lilly announced in September an agreement to supply up to 220,000 doses to the European Union.

* The United States bought 100,000 doses of the antibody cocktail in February, followed by 388,000 doses of etesevimab in September. The country had already committed to buying a total of 1,450,000 doses of bamlanivimab alone.

GLAXOSMITHKLINE

* GlaxoSmithKline and Vir Biotechnology partnered to develop the COVID-19 antibody drug sotrovimab.

* It was shown in a trial to work as well when given as a shot in the arm as when administered as an infusion.

* In May, the FDA granted sotrovimab an EUA for treating mild-to-moderate COVID-19 in people aged 12 years and older.

* The EU's drug regulator in June backed its use for patients at risk of severe disease who do not need supplemental oxygen.

* It received approval as a COVID-19 treatment in Japan in September and in Britain in December.

TRIALS:

* Laboratory analysis indicates the drug is effective against the new Omicron variant.

* The treatment resulted in a 79% reduction in risk of hospitalisation for more than 24 hours or death due to any cause, a late-stage study showed in June.

SUPPLY DEALS:

* The United States has signed contracts worth about $1 billion to secure the treatment, with supply expected by Dec. 17.

* The EU signed in July a contract with GSK for the supply of up to 220,000 doses of sotrovimab.

* It also signed a deal to supply 10,000 doses to Canada.

REGENERON

* The single-dose antibody cocktail Ronapreve, known as REGEN-COV in the U.S. and developed by Regeneron and Roche is a combination of two antibodies (casirivimab and imdevimab) and can be taken via injection or infusion.

* In mid-July, Japan became the first country to authorise the treatment, swiftly followed by the United States and Britain.

* REGEN-COV has received emergency approval from more than 20 countries for both the prevention and treatment of COVID-19.

* The EU drug regulator recommended Ronapreve for treatment in patients over 12 who do not require oxygen support and are at high risk of severe disease, and for prevention in people over 12 weighing at least 40 kilograms (88 lb).

* The therapy could be less effective against Omicron, the company said on Nov. 30.

TRIALS:

* Regeneron said on Nov. 8 that a single dose reduced the risk of contracting COVID-19 by 81.6% in a late-stage trial, in the two to eight months following the drug's administration.

* In June, a late-stage trial showed it reduced the risk of death by 20% for hospitalised patients whose own immune systems had not produced a response.

* Earlier in April, it was announced REGEN-COV helped cut the risk of symptomatic infections by 81% among people in households where another member had become ill.

* It is also effective in preventing COVID-19 in people exposed to COVID-19, while a separate study indicated it could fight the Beta variant.

SUPPLY DEALS:

* As of September, the U.S. government had purchased nearly 3 million doses.

* In June, the EU secured 55,000 doses for 37 countries, including Britain and other non-EU nations.

(Compiled by Lucinda Langlands-Perry and Valentine Baldassari in Gdansk; Editing by Milla Nissi and Catherine Evans)

(c) Copyright Thomson Reuters 2021. Click For Restrictions -
https://agency.reuters.com/en/copyright.html