Eli Lilly Secures $375M U.S. Government Order for COVID-19 Antibody; GSK/Sanofi Commit 200M Doses to COVAX

Compiled by Fan Dongdong

Currently, major pharmaceutical companies worldwide are actively advancing the research and development of treatments for COVID-19. Recently, two additional drugs have secured orders from government and public health agencies.

On Wednesday, Eli Lilly announced that the U.S. government had reached a deal worth up to $375 million with the company to purchase 300,000 doses of its antibody therapeutic drug bamlanivimab (LY-CoV555).

It is reported that the prerequisite for closing this transaction is the FDA’s Emergency Use Authorization (EUA) for LY-CoV555. Furthermore, the agreement grants the U.S. government an option to purchase an additional 650,000 doses and ensures that patients will not incur any out-of-pocket costs for this medication.

Despite Eli Lilly’s LY-CoV555 having previously suspended research due to a lack of evidence for efficacy, this does not appear to have deterred the U.S. government from placing a significant bet on the drug. The trial was halted because “there is a low likelihood that clinical benefit would be observed with LY-CoV555 treatment intervention in the hospitalized patient population.” The regulatory committee, NIAID, noted that LY-CoV555 is unlikely to help hospitalized COVID-19 patients recover from the later stages of the disease. [Related Reading:Eli Lilly’s Global Revenue in Q3 Reaches $5.741 Billion; Hospitalized Patient COVID-19 Antibody Trial Suspended】

However, Eli Lilly had already applied to the FDA for emergency use authorization of LY-CoV555 in early October. Eli Lilly stated that it remains confident in LY-CoV555’s ability to prevent disease progression in patients with early-stage COVID-19. According to previously released trial data from Eli Lilly and Incyte Corporation, LY-CoV555 in combination with Gilead’s remdesivir reduced patients’ recovery time and improved clinical outcomes in COVID-19 patients, compared with remdesivir monotherapy.

The government procurement agreement is undoubtedly good news for LY-CoV555. However, even if LY-CoV555 receives FDA approval, Eli Lilly will still lag behind Regeneron, which signed a $450 million supply deal with the U.S. government this July. Regeneron has already ramped up production capacity to ensure it can manufacture up to 300,000 doses of COVID-19 therapeutic drugs and 1.3 million doses of COVID-19 prophylactic drugs.

On the other hand, although Sanofi and GlaxoSmithKline are not the frontrunners in the race to develop COVID-19 vaccines, the two companies recently announced that they will provide 200 million doses of their jointly developed experimental COVID-19 vaccine to the COVAX Facility.

The financial details of the agreement reached between the two companies and COVAX have not yet been disclosed. COVAX, co-led and implemented by Gavi, the Vaccine Alliance (GAVI), the World Health Organization (WHO), and the Coalition for Epidemic Preparedness Innovations (CEPI), aims to accelerate the development and manufacturing of COVID-19 vaccines and ensure equitable access for all countries, including facilitating access to safe and effective vaccines for nations with no vaccine development capabilities or those with low incomes.

Although Sanofi and GlaxoSmithKline’s COVID-19 vaccines have not yet reached late-stage clinical trials, experts state that the two pharmaceutical giants’ reliable proprietary platforms and global supply capabilities position them to become key players in COVID-19 vaccination programs in the long term. Currently, both companies expect to initiate late-stage clinical trials of their COVID-19 vaccines before the end of this year. Pending successful clinical trial results, they plan to submit regulatory approval applications in the first half of next year. Meanwhile, both companies are scaling up production with the goal of achieving an annual manufacturing capacity of up to 1 billion doses.

In addition to the agreement reached with COVAX, the two companies have also partnered with the European Union to supply 300 million vaccine doses, and will provide up to 600 million doses to the U.S. market. Meanwhile, Pfizer, Johnson & Johnson, AstraZeneca, Moderna, and Novavax are conducting late-stage clinical trials of their respective vaccine candidates. The novel mRNA vaccines developed by Pfizer and Moderna are progressing more rapidly; some experts indicate that these vaccines could potentially be authorized for use as early as late 2020 or early 2021.

References:

1.Eli Lilly nabs $375M deal to supply COVID-19 antibody to U.S. government despite trial failure

2.Sanofi, GSK to provide 200M coronavirus vaccines to COVAX for equitable distribution

Original Title:Eli Lilly’s COVID-19 Antibody Secures $375 Million Government Order; GSK/Sanofi to Provide 200 Million Doses of COVID-19 Vaccine to COVAX