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Eli Lilly (LLY - Free Report) announced a combination of its antibody drugs, bamlanivimab (700 mg) and etesevimab (1400 mg) reduced hospitalizations and death in a phase III study evaluating the cocktail therapy in high-risk patients recently diagnosed with COVID-19.
This data from a new cohort of the BLAZE-1 phase III study showed that the bamlanivimab/etesevimab cocktail reduced risk of hospitalizations and death by 87% in the said patient group. The antibody combination also demonstrated statistically significant improvements on key secondary endpoints. Meanwhile, there were four deaths in this new cohort, all of which were assumed to be related to COVID-19 and all of which occurred in patients taking placebo. There were no deaths in patients receiving the bamlanivimab/etesevimab cocktail therapy.
The new data support the efficacy and safety of the combination of bamlanivimab 700 mg and etesevimab 1400 mg, the dose granted emergency use authorization (EUA), last month, for the treatment of mild-to-moderate COVID-19 in patients who are at high risk of progressing to severe COVID-19. The EUA was based on data from another cohort of the BLAZE-1 study.
Earlier this month, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) also gave a position opinion recommending approval of bamlanivimab, as a monotherapy as well as in combination with etesevimab for the treatment of confirmed COVID-19 in Europe.
Lilly’s stock has risen 22.2% this year so far against 0.7% decrease of the industry.
Bamlanivimab was granted EUA by the FDA in November 2020 as a monotherapy for high-risk patients recently diagnosed with mild-to-moderate COVID-19. Bamlanivimab alone is now authorized for emergency/temporary use in numerous countries.
Meanwhile, other studies are ongoing on bamlanivimab in other patient populations and also in combination with etesevimab. In February, Lilly announced a deal with Vir Biotech (VIR - Free Report) and Glaxo (GSK - Free Report) to expand its ongoing BLAZE-4 study to evaluate bamlanivimab (700mg) with Vir Biotech/Glaxo’s investigational COVID-19 antibody, VIR-7831 (500mg) in low-risk patients with mild-to-moderate COVID-19.
The FDA also granted EUA to Lilly and Incyte’s (INCY - Free Report) oral JAK inhibitor Olumiant for use in combination with Gilead’s remdesivir to treat hospitalized COVID-19 patients in November 2020.
Bamlanivimab was a key driver of Lilly’s sales growth in the fourth quarter, contributing $871.2 million in sales due to a key supply contract with the U.S. government. Sales should be higher in 2021 with emergency approval received for bamlanivimab/etesevimab cocktail.In fact, in 2021, Lilly expects to generate revenues in the range of $1-$2 billion from COVID-19 therapies.
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Lilly (LLY) COVID-19 Antibody Combo Cuts Death/Hospitalization
Eli Lilly (LLY - Free Report) announced a combination of its antibody drugs, bamlanivimab (700 mg) and etesevimab (1400 mg) reduced hospitalizations and death in a phase III study evaluating the cocktail therapy in high-risk patients recently diagnosed with COVID-19.
This data from a new cohort of the BLAZE-1 phase III study showed that the bamlanivimab/etesevimab cocktail reduced risk of hospitalizations and death by 87% in the said patient group. The antibody combination also demonstrated statistically significant improvements on key secondary endpoints. Meanwhile, there were four deaths in this new cohort, all of which were assumed to be related to COVID-19 and all of which occurred in patients taking placebo. There were no deaths in patients receiving the bamlanivimab/etesevimab cocktail therapy.
The new data support the efficacy and safety of the combination of bamlanivimab 700 mg and etesevimab 1400 mg, the dose granted emergency use authorization (EUA), last month, for the treatment of mild-to-moderate COVID-19 in patients who are at high risk of progressing to severe COVID-19. The EUA was based on data from another cohort of the BLAZE-1 study.
Earlier this month, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) also gave a position opinion recommending approval of bamlanivimab, as a monotherapy as well as in combination with etesevimab for the treatment of confirmed COVID-19 in Europe.
Lilly’s stock has risen 22.2% this year so far against 0.7% decrease of the industry.
Bamlanivimab was granted EUA by the FDA in November 2020 as a monotherapy for high-risk patients recently diagnosed with mild-to-moderate COVID-19. Bamlanivimab alone is now authorized for emergency/temporary use in numerous countries.
Meanwhile, other studies are ongoing on bamlanivimab in other patient populations and also in combination with etesevimab. In February, Lilly announced a deal with Vir Biotech (VIR - Free Report) and Glaxo (GSK - Free Report) to expand its ongoing BLAZE-4 study to evaluate bamlanivimab (700mg) with Vir Biotech/Glaxo’s investigational COVID-19 antibody, VIR-7831 (500mg) in low-risk patients with mild-to-moderate COVID-19.
The FDA also granted EUA to Lilly and Incyte’s (INCY - Free Report) oral JAK inhibitor Olumiant for use in combination with Gilead’s remdesivir to treat hospitalized COVID-19 patients in November 2020.
Bamlanivimab was a key driver of Lilly’s sales growth in the fourth quarter, contributing $871.2 million in sales due to a key supply contract with the U.S. government. Sales should be higher in 2021 with emergency approval received for bamlanivimab/etesevimab cocktail.In fact, in 2021, Lilly expects to generate revenues in the range of $1-$2 billion from COVID-19 therapies.
Lilly currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Breakout Biotech Stocks with Triple-Digit Profit Potential
The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases.
Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +50%, +83% and +164% in as little as 2 months. The stocks in this report could perform even better.
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