The good news just keeps coming for Regeneron Pharmaceuticals, a US biotech company whose potent cocktail of antibodies has been shown to not only treat Covid-19 infections, but also prevent them.
The cocktail, dubbed Regen-Cov, is not a vaccine but an effective treatment for mild to moderate Covid; it also prevents symptomatic Covid among those who have been exposed to it. Not just that, but in recent clinical trials it’s been proven to respond to highly transmissible new Covid variants.
That ’s good news for SA. A local variant, 501Y.V2, delivered all kinds of curve balls and fuelled the second wave of the virus in the country. The variant carries a mutation that appears to make the virus more contagious or easy to spread and may cause it to escape some of the antibodies vaccines will deliver.
Regen-Cov makes use of monoclonal antibodies, man-made proteins that act like human antibodies in the immune system. SA is no stranger to these antibody treatments. Recent successful trials used cocktails of monoclonal antibodies to block strains of HIV.
As Regeneron CEO Leonard Schleifer told CNBC: "If you have Covid and you’re an outpatient and you’re at risk, we can decrease the number of people who get hospitalised or die by 70% by treating these appropriate patients early ... And we can treat people before they’re infected. And we can show you can block 80% of infections in people who are at risk to be infected with the virus."
Schleifer said society needs to have other weapons besides just vaccination. The advantage of this cocktail is that it begins to protect from infection within days of being administered. As such, it has raised hopes that the treatment may be an alternative or complement to vaccination programmes — especially in countries such as SA, where the rollout has been sluggish.
The concept of monoclonal antibodies has been used in the treatment of cancer and autoimmune diseases and in HIV research in SA.
Monoclonal antibodies are manufactured in a lab and help our bodies fight infection; they are delivered through a vein or as an injection.
Using antibodies to prevent disease differs from vaccination. A vaccine instructs the body to create antibodies to fight an illness. Using antibodies as a treatment skips using a person’s body to manufacture them, giving lab-made antibodies directly to a patient.
One of the scientists involved in the Regeneron trial, Myron Cohen, tested monoclonal antibodies as a means of preventing an HIV infection in a trial that took place in 12 countries, including SA.
The Regen-Cov treatment has already secured emergency use authorisation from the Food & Drug Administration (FDA) in the US for treatment of mild to moderate Covid, and the company is now looking for an extended use of the treatment based on encouraging new findings from phase 3 clinical trials, which are still to be peer reviewed.
While Regeneron is focused on the US market for now, exporting its products to SA may not necessarily require that it be registered here. It could follow the route of the Pfizer-BioNTech Covid-19 vaccine (which also holds emergency use authorisation from the FDA) and bypass the lengthy drug registration process by applying to the SA Health Products Regulatory Authority for authorisation to sell the drug in SA under section 21 of the Medicines Act.
US investors are hoping to make a mint. While Regeneron is trading at $488 a share, it’s yet to climb back to $660 a share — a record high reached in July last year, when late stage clinical trials were launched.
With a target price as high as $675, according to Barclays analysts, there is still room for the share to rise, but there are of course risks too.
According to stock analysis service Trefis, Regeneron stock has had ups and downs based on developments around its Covid antibody cocktail, but "it isn’t really going to be a big boost for its top-line in the long run".
Rather, its non-Covid treatments are the major revenue drivers, including Eylea — a treatment for serious eye conditions — which is set to make close to $8bn in annual sales for the next few years, while eczema drug Dupixent is expected to have peak sales north of $10bn. The antibody drug meanwhile garnered just $146m in sales for the three months ended in December 2020.
According to Barclays analysts, consensus estimates for Regen-Cov sales sit at $512m and $1.2bn in the first and second quarters of 2021 respectively.
The US government is obligated to purchase all finished Regen-Cov doses supplied by June 30 2021 — up to 1.25-million at the same price point — which could provide a $2.6bn sales bonus for Regeneron in the second quarter.
With Katherine Child
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