Vir Biotechnology : GSK and Vir Biotechnology announce Joint Procurement Agreement with European Commission for COVID-19 treatment sotrovimab
July 29, 2021 at 10:36 am EDT
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GlaxoSmithKline plc and Vir Biotechnology, Inc. today announced they have signed a Joint Procurement Agreement with the European Commission to supply up to 220,000 doses of sotrovimab, an investigational single dose SARS-CoV-2 monoclonal antibody for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with COVID-19 who do not require oxygen supplementation and who are at risk of progressing to severe COVID-19.
The Joint Procurement Agreement enables participating European Union (EU) Member States to quickly purchase sotrovimab, following local emergency authorisation or authorisation at the EU level, to treat high-risk patients with COVID-19 who may benefit from early treatment with sotrovimab.
This action follows the positive scientific opinion issued by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP), under Article 5(3) of Regulation 726/2004, which can be considered by the national authorities in EU Member States when taking evidence-based decisions on the early use of the medicine prior to marketing authorisation. 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 authorisation application for sotrovimab is under rolling regulatory review with the EMA. In June, the companies announced confirmatory full results for the Phase 3 COMET-ICE trial, which resulted in a 79% reduction (adjusted relative risk reduction) (p
Vir Biotechnology, Inc. is an immunology company, which is focused on combining cutting-edge technologies to treat and prevent serious infectious diseases and other serious conditions. The Company's clinical development pipeline consists of product candidates targeting hepatitis delta virus (HDV), hepatitis B virus (HBV), and human immunodeficiency virus (HIV). It also has several preclinical candidates in its pipeline including those targeting influenza A and B, COVID-19, respiratory syncytial virus and human metapneumovirus (RSV and MPV), and human papillomavirus (HPV). The Company's pipeline includes VIR-1949, VIR-7229, VIR-2981, VIR-8190, and HIV Cure. It also engaged in developing tobevibart, a monoclonal antibody also known as VIR-3434, and Elebsiran, an siRNA also known as VIR-2218, for the treatment and suppression of chronic HDV. Its Elebsiran is an investigational HBV-targeted siRNA that reduces HBsAg, a protein which is required for the HDV viral life cycle.
VIR BIOTECHNOLOGY, INC. 
