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Glaxo (GSK), Vir to Supply COVID Drug Sotrovimab to Government
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GlaxoSmithKline (GSK - Free Report) and Vir Biotechnology (VIR - Free Report) announced that they have signed a contract agreement with the U.S. government for the supply of its monoclonal antibody for the early treatment of COVID-19, sotrovimab. Glaxo will supply doses of the candidate worth approximately $1 billion to the U.S. government by Dec 17, 2021.
We note that Glaxo and Vir Biotechnology’s sotrovimab, as an intravenous administration, was granted emergency use authorization (“EUA”) by the FDA for treating mild-to-moderate COVID-19 in adult and pediatric patients in May. The intravenous drug is available with the trade name of Xevudy.
Per the contract, the U.S. government has an option to purchase additional doses of the drug through March 2022. With this contract, Glaxo and Vir Biotechnology have agreements with several entities across the globe in place for supply of more than 750,000 doses of sotrovimab. The companies also have an agreement with the European Commission for additional doses.
These deals represent the potential of sotrovimab in treating COVID-19 and also boost prospects of both companies, especially the smaller biotech Vir Biotechnology, as they will generate significant revenues for the companies going forward.
Meanwhile, Glaxo and Vir Biotechnology have developed an intramuscular administration option for sotrovimab. Earlier this week, the companies announced data from a late-stage study demonstrating non-inferiority of intramuscular administration to intravenous administration in reducing hospitalization and risk of death.
Based on the non-inferiority of the intramuscular administration of sotrovimab, Glaxo and Vir Biotechnology are planning for regulatory submissions of the same globally. The companies are also in discussion with the FDA to include the intramuscular administration in the existing EUA for sotrovimab. A potential EUA for the intramuscular administration of sotrovimab will provide a more convenient administration option for COVID-19 patients compared to the intravenous administration.
So far this year, Glaxo’s shares have risen 15.6% compared with the industry’s 15.5% increase.
Image Source: Zacks Investment Research
We note that there are two other FDA-authorized treatment monoclonal antibodies available for non-hospitalized COVID-19 patients — Eli Lilly’s (LLY - Free Report) cocktail therapy, bamlanivimab plus etesevimab and Regeneron’s (REGN - Free Report) antibody cocktail, REGEN-COV (casirivimab and imdevimab).
Lilly’s COVID-19 antibody cocktail, bamlanivimab plus etesevimab, was granted emergency approval by the FDA in February 2021 to treat mild-to-moderate COVID-19 in high-risk patients based on data from the BLAZE-1 study.
In September, the FDA expanded the EUA for the cocktail antibody medicine to include the post-exposure prevention (prophylaxis) for COVID-19 indication. Lilly’s cocktail medicine generated revenues of $217.1 million in the third quarter of 2021.
Regeneron’s antibody cocktail, REGEN-COV comprises two monoclonal antibodies, casirivimab and imdevimab. It has become a significant contributor to Regeneron’s top line in the recent quarters.
Regeneron added $3.5 billion to its top line from sales of REGEN-COV, leading to more than 100% increase in total revenues in the first nine months of 2021.
In a separate press release, Glaxo announced that the European Commission has approved the label expansion of its asthma drug, Nucala, to include patients with hypereosinophilic syndrome, eosinophilic granulomatosis with polyangiitis and chronic rhinosinusitis with nasal polyps.
Image: Shutterstock
Glaxo (GSK), Vir to Supply COVID Drug Sotrovimab to Government
GlaxoSmithKline (GSK - Free Report) and Vir Biotechnology (VIR - Free Report) announced that they have signed a contract agreement with the U.S. government for the supply of its monoclonal antibody for the early treatment of COVID-19, sotrovimab. Glaxo will supply doses of the candidate worth approximately $1 billion to the U.S. government by Dec 17, 2021.
We note that Glaxo and Vir Biotechnology’s sotrovimab, as an intravenous administration, was granted emergency use authorization (“EUA”) by the FDA for treating mild-to-moderate COVID-19 in adult and pediatric patients in May. The intravenous drug is available with the trade name of Xevudy.
Per the contract, the U.S. government has an option to purchase additional doses of the drug through March 2022. With this contract, Glaxo and Vir Biotechnology have agreements with several entities across the globe in place for supply of more than 750,000 doses of sotrovimab. The companies also have an agreement with the European Commission for additional doses.
These deals represent the potential of sotrovimab in treating COVID-19 and also boost prospects of both companies, especially the smaller biotech Vir Biotechnology, as they will generate significant revenues for the companies going forward.
Meanwhile, Glaxo and Vir Biotechnology have developed an intramuscular administration option for sotrovimab. Earlier this week, the companies announced data from a late-stage study demonstrating non-inferiority of intramuscular administration to intravenous administration in reducing hospitalization and risk of death.
Based on the non-inferiority of the intramuscular administration of sotrovimab, Glaxo and Vir Biotechnology are planning for regulatory submissions of the same globally. The companies are also in discussion with the FDA to include the intramuscular administration in the existing EUA for sotrovimab. A potential EUA for the intramuscular administration of sotrovimab will provide a more convenient administration option for COVID-19 patients compared to the intravenous administration.
So far this year, Glaxo’s shares have risen 15.6% compared with the industry’s 15.5% increase.
We note that there are two other FDA-authorized treatment monoclonal antibodies available for non-hospitalized COVID-19 patients — Eli Lilly’s (LLY - Free Report) cocktail therapy, bamlanivimab plus etesevimab and Regeneron’s (REGN - Free Report) antibody cocktail, REGEN-COV (casirivimab and imdevimab).
Lilly’s COVID-19 antibody cocktail, bamlanivimab plus etesevimab, was granted emergency approval by the FDA in February 2021 to treat mild-to-moderate COVID-19 in high-risk patients based on data from the BLAZE-1 study.
In September, the FDA expanded the EUA for the cocktail antibody medicine to include the post-exposure prevention (prophylaxis) for COVID-19 indication. Lilly’s cocktail medicine generated revenues of $217.1 million in the third quarter of 2021.
Regeneron’s antibody cocktail, REGEN-COV comprises two monoclonal antibodies, casirivimab and imdevimab. It has become a significant contributor to Regeneron’s top line in the recent quarters.
Regeneron added $3.5 billion to its top line from sales of REGEN-COV, leading to more than 100% increase in total revenues in the first nine months of 2021.
In a separate press release, Glaxo announced that the European Commission has approved the label expansion of its asthma drug, Nucala, to include patients with hypereosinophilic syndrome, eosinophilic granulomatosis with polyangiitis and chronic rhinosinusitis with nasal polyps.
GlaxoSmithKline plc Price
GlaxoSmithKline plc price | GlaxoSmithKline plc Quote
Zacks Rank
Glaxo currently has a Zacks Rank #2 (Buy) while Vir Biotechnology carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.