Benzinga | Jul 28, 2021 07:13AM EDT

European Commission To Procure 220K Doses Of Glaxo-Vir Biotech's COVID-19 Antibody

* GlaxoSmithKline plc (NYSE:GSK) and Vir Biotechnology Inc (NASDAQ:VIR) have signed a Joint Procurement Agreement with the European Commission to supply up to 220,000 doses of COVID-19 antibody.

* The agreement covers sotrovimab, an investigational single dose monoclonal antibody for treating adults and adolescents (aged 12 years and over and weighing at least 40 kg) with COVID-19 who do not require oxygen supplementation and are at risk of progressing to severe COVID-19.

* This action follows the positive scientific opinion issued by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP).

* Sotrovimab is included in the European Commission's portfolio of promising candidate therapies as part of its COVID-19 Therapeutics Strategy.

* In addition, the documentation to support the forthcoming marketing authorization for sotrovimab is under rolling regulatory review with the EMA.

* In June, full results from the Phase 3 COMET-ICE trial showed a 79% reduction in hospitalizations for more than 24 hours or death due to any cause by Day 29 compared to placebo, meeting the primary endpoint of the trial.

* GSK and Vir plan to submit a marketing application to the FDA in 2H of 2021.

* In May, sotrovimab received an emergency use nod from the FDA for treating mild-to-moderate COVID-19.

* Price Action: VIR shares closed at $36.44 on Tuesday, while GSK stock is up 0.58% at $39.75 during the premarket session on the last check Wednesday.