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Regeneron (REGN), Roche Get EC Nod for COVID-19 Cocktail

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Regeneron Pharmaceuticals, Inc. (REGN - Free Report) and partner Roche (RHHBY - Free Report) recently announced that the European Commission (“EC”) has approved the casirivimab and imdevimab antibody cocktail for people aged 12 years and older. It will be used for the treatment of non-hospitalized patients (outpatients) with confirmed COVID-19 who do not require oxygen supplementation and who are at increased risk of progressing to severe COVID-19, and to prevent the disease.

The cocktail is known as REGEN-COV in the United States and Ronapreve in the European Union and other countries.

The approval comes close on the heels of a positive opinion by the European Medicines Agency's (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”).

The EC approval is based on positive data from two phase III studies involving more than 6,000 individuals that evaluated the efficacy and safety of the antibody cocktail to treat non-hospitalized patients already infected with SARS-CoV-2, and to prevent symptomatic infection in asymptomatic household contacts of SARS-CoV-2 infected individuals.

Data from various studies showed that the antibody cocktail reduced the risk of hospitalization or death by 70%. It reduced the risk of symptomatic infections by 82% in the prevention setting. Regeneron also reported that recently released data, which is not yet reviewed by the EMA, suggest that a single dose provided long-term protection against COVID-19, beyond the currently authorized once-monthly dosing.

Regeneron and Roche intend to submit a future type II variation to the EMA that seeks to expand the indication to include the treatment of patients hospitalized because of COVID-19.

We note that the cocktail is not approved by the FDA, but is currently authorized under an Emergency Use Authorization (EUA) for use in certain post-exposure prophylaxis settings and as a treatment for non-hospitalized people with mild to moderate COVID-19 who are at high risk of serious consequences from COVID-19.

Last month, the FDA accepted for priority review the first of two Biologics License Applications (BLAs) for REGEN-COV to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals. The second BLA submission will focus on those hospitalized because of COVID-19 and is expected to be completed later this year.

Given a surge in cases in some European countries, sales from the cocktail should see a steady increase.

Global sales from the cocktail came in at $4.7 billion in the first nine months of 2021. Regeneron invented the antibody cocktail. Roche is primarily responsible for the development and distribution of the cocktail outside the United States.

Regeneron’s shares have gained 30.7% in the year so far against the industry’s decline of 14.2%.

 

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In September, Regeneron announced a new agreement with the U.S. government to supply an additional 1.4 million 1,200 mg doses of REGEN-COV by January 2022.

The cocktail has significantly boosted Regeneron’s top line this year and the momentum is expected to continue.

Meanwhile, the FDA has also issued an EUA for Vir Biotechnology (VIR - Free Report) and GlaxoSmithKline’s (GSK - Free Report) investigational monoclonal antibody therapy sotrovimab for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients. The CHMP is conducting a rolling review of data on sotrovimab to support a forthcoming application.

Vir and Glaxo now plan to submit a BLA to the FDA in the first half of 2022.

Vir and Glaxo also continue to advance trials evaluating intramuscular (IM) administration of sotrovimab to increase patient access and convenience.

Regeneron currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.


 

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