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

GlaxoSmithKline plc GSK and Vir Biotechnology Inc 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.