Regeneron and recently signed-on partner Roche, with additional help from the National Institutes of Health, are leading the global race to develop antibody programs against COVID-19. By one analyst’s estimate, their candidate alone could bring in more sales next year than what Regeneron recorded for all of its products in 2019.
The Regeneron-Roche COVID-19 antibody cocktail, dubbed REGN-COV2, could see sales as high as $6 billion next year, according to Morningstar analyst Karen Andersen. That number factors in a 60% probability for approval this year, which means that if the cocktail scores a green light before 2021, the drug could even hit $10 billion.
The $6 billion was double the $3 billion in peak sales Andersen pegged for Gilead Sciences’ small-molecule drug Veklury (remdesivir), and it also topped Regeneron’s total product sales in 2019, which tallied $4.8 billion.
“We see targeted antibody programs like Regeneron/Roche’s REGN-COV2 cocktail as a powerful way to treat or prevent COVID-19 in immune compromised or elderly populations,” Andersen wrote in a report, though she did say she expects the high-flying sales success to be short-lived; sales will rapidly decline after 2021 and practically disappear in 2023 as herd immunity is built, she figures.
Experts that SVB Leerink analyst Geoffrey Porges recently interviewed shared her positive view. “[O]ur KOLs praised Regeneron’s cocktail antibody approach, and believe the passive immunization through [monoclonal antibodies] could play a major role in COVID prevention in addition to treatment use,” Porges wrote in an investor note last week.
Compared with vaccines, which are being supplied to the U.S. government at $24 on average for a two-dose regimen, antibody drugs could be way more expensive, as they are typically priced well into the thousands, Andersen noted. But antibodies could be particularly useful for older adults, whose immune systems may not respond as well to vaccination.
REGN-COV2 is currently being evaluated in several mid- and late-stage trials, both for its ability to prevent infection among people who have had close contact to infected individuals and for treating hospitalized and non-hospitalized COVID-19 patients.
The hope is that combining two monoclonal antibodies targeting two different sites of the spike protein on the surface of SARS-CoV-2 will prevent the virus from becoming resistant to treatment. That approach was previously validated with the clinical success of Regeneron’s Ebola program, REGN-EB3, a mixture of three monoclonal antibodies that’s under FDA priority review for a target decision date in October.
Production scale-up is also a major hurdle for antibody therapies and part of the reason why they're so pricey. With Roche having signed on a few days ago, the pair is aiming to increase the manufacturing capacity by at least 3.5 times. “The expanded drug supply from Roche is likely to provide much greater capacity to supply international markets, which otherwise could be constrained or crowded out by U.S. government orders,” Porges said in a note at the time.
The U.S. Department of Health and Human Services and Department of Defense previously tapped Regeneron to supply up to 1.6 million doses of REGN-COV2 for the U.S. in a deal worth $450 million.
Regeneron’s program is currently the most advanced in COVID-19 antiviral antibody drugs, but many other companies are not too far behind.
Last month, Eli Lilly pushed its AbCellera-partnered LY-CoV555 into a phase 3 trial for the prevention of SARS-CoV-2 infection or COVID-19 disease in residents and staff at nursing homes. Lilly is also developing LY-CoV016 through a licensing deal with China’s Junshi Biosciences. Now, a phase 2 trial is testing a combination of the two antibodies in patients with early mild to moderate COVID-19.
AstraZeneca, which is also a frontrunner in the vaccine field, just launched a phase 1 trial of its own two-antibody COVID-19 cocktail, AZD7442. China’s Brii Biosciences, in collaboration with Tsinghua University and Shenzhen No.3 People’s Hospital, has two monoclonal antibodies, BRII-196 and BRII-198, in phase 1 testing, with potential for a combination.