In October of 2020, the FDA approved the antibody cocktail of Regeneron to treat COVID-19 infection. This antibody cocktail could only be used in the case of mild to moderate infections of the SARS-CoV-2 virus in pediatric, adult, and senior patients who were at a high risk of developing severe COVID-19 symptoms. This cocktail, called REGEN-COV, was made of monoclonal imdevimab and casirivimab.
Later in May of 2021, more patients became eligible for this monoclonal drug when the threshold for the “unhealthy weight” criterion was lowered by the FDA. The FDA also started including ethnicity and race as factors to make the treatment more inclusive. The pool of potentially eligible people who can take the drug has now increased to 75 percent of the total adult American population. It became easier for doctors to dispense this drug further in June 2021, when the FDA approved the administration of REGEN-COV through injections rather than as an antibody cocktail infusion.
When infections because of the Delta variant surged among the unvaccinated population in the US, REGEN-COV started being used even more. The potential of using REGEN-COV as a prophylactic soon became apparent too.
According to the Phase 3 data, scientists realized that they could reduce the risk of infections by as much as 80 percent if they administered REGEN-COV to people who had been in close contact with COVID-19 positive individuals. Therefore, FDA approved the administration of the drug as a prophylactic to not just recently infected individuals but also to people who were at the risk of exposure to the virus in crowded institutional spaces like nursing homes or prisons.
The Boom Of Regen-Cov Sales In 2021
During the second quarter of 2021, the sale of monoclonal drugs soared. Regeneron made $2.6 billion in Q2 of 2021 through the sale of REGEN-COV alone. Compared to the $2.53 billion that it made for the sale of all of its other products combined in the first quarter of 2021, this is a stupendous performance.
Though US citizens themselves did not need to pay for the drug if they were at the risk of developing severe symptoms, the US government had to pay Regeneron $2,100 for every dose of treatment. Multiply that to the 600,000 doses that have been administered since then and you will see how they made such an enormous profit. Ever since its prophylactic usage was discovered, sales have soared even higher. From 25,000 doses being sold per week, the number rose to 50,000 per week during the end of July to 100,000 doses being sold during the beginning of August. The number of REGEN-COV doses sold in the second week of August boomed to 135,000.
There was another reason why REGEN-COV overtook the market. Its competitor Eli Lilly’s antibody cocktail for COVID-19 was pulled from the market by the FDA after scientists realized that it had no effects on the coronavirus variants that have been found in South Africa and Brazil. Previously, Eli Lilly’s antibody cocktail had been preferred over Regeneron’s cocktail because it was cheaper. Currently, the sales of Eli Lilly have plummeted to zero.
However, the elimination of the competition from the market has increased the demand for REGEN-COV even further. Concerns have been raised over whether Regeneron can keep up its supply through possible surges of infection in the future. Though Regeneron reported that they still had ample supplies left, they also did admit that the current supply could run out by the end of the year. However, if they keep manufacturing fresher batches of the antibody cocktail, there is no looming danger of a shortage crisis on the horizon.
The Critical Shortage Of Monoclonal Drugs
REGEN-COV is not the only monoclonal drug that is vulnerable to the danger of a shortage crisis. Actemra from Roche/Genentech was a monoclonal drug that was being used to treat patients with severe COVID-19 symptoms. It had previously been a drug that was used to treat rheumatoid arthritis.
It did so by blocking the IL-6 receptor. Actemra attacked the COVID-19 virus by counteracting the cytokine storm which was suspected to be the real cause of death among COVID-19 patients with severe complications. Actemra, unlike REGEN-COV, is used together with corticosteroids because it cannot attack the virus directly.
Though China had already proposed this treatment as a solution in the early months of 2020, the FDA finally gave Actemra the Emergency Use Authorization (EUA) in June of 2021. Only the patients who were on oxygen support could receive the drug.
However, the critical shortage of Actemra became obvious during the Delta variant surge, when a large number of patients had to be hospitalized at once. There was another adverse impact of this shortage. The patients with rheumatoid arthritis started finding it almost impossible to get their hands on this drug which was part of their routine treatment.
The Role Of Marine Bio In This Crisis
Since REGEN-COV is the only viable monoclonal drug on the market now, other options must be discovered as well. Especially ones that can treat the severe symptoms of COVID-19 like Actemra could, without interfering with the health of the patients who needed the drug for its original purpose (that is, to treat rheumatoid arthritis). For this purpose of experimentation, contract lab services are necessary.
As most scientists and researchers will already know, the FDA has some very strict guidelines on what makes contract lab services eligible for the production of life-saving drugs. MarinBio Laboratory is an FDA-registered contract lab service that provides companies with highly qualified researchers who make sure that all tests are performed in the most speedy, secure, and accurate way possible.
Good contract lab services make sure that the drug production process is flexible, efficient, and safe. This is exactly what you can expect from MarinBio, which makes its contract lab services a suitable option for such research.
