Ex-FDA chief Gottlieb pushes for antibody manufacturing scale up as 2021 pandemic ‘insurance policy’
Even as COVID-19 vaccines start to creep across the regulatory finish line, supplies will be limited for months at least. Meanwhile, antibody drugs, hailed as a crucial stopgap treatment since the pandemic’s early days, are scarce, thanks to federal manufacturing missteps earlier this year.
But the U.S. government has the power to ratchet up production of COVID-19 antibody therapies—a move it should pursue if it hopes to snare an “insurance policy” against the pandemic in 2021, former FDA Commissioner Scott Gottlieb, M.D., wrote in The Wall Street Journal.
The two antibodies sporting an emergency nod in the U.S.—Regeneron’s cocktail REGN-COV2 and Eli Lilly’s bamlanivimab—aren’t that difficult to make, but supplies are tight because the government failed to lock down sufficient manufacturing space in the spring, Gottlieb said.
While the companies have taken it upon themselves to boost production—freeing up domestic manufacturing space by shifting other drugs to places like Europe and inking deals with large manufacturers—Regeneron and Lilly together are expected to produce a slim 6 million to 7 million doses next year.
That’s not nearly enough for a drug that many have touted as a necessary backup treatment before vaccines are widely available, Gottlieb said.
All is not lost, though. The government could pay companies for access to their manufacturing space, and it could step in to assuage the risks for companies willing to become contract manufacturers for the COVID-19 treatments, Gottlieb argued.
Further, the government could agree to buy the antibodies and stockpile them at a “worthwhile” price. Plus, Regeneron and Lilly could be paid to license their drugs, he said.
A manufacturer can’t suddenly start pumping out antibodies overnight, Gottlieb conceded. It takes about six months to convert a facility to produce the COVID-19 treatments and another six months to convert it back to its original purpose, he said. A big facility moving at full speed for about eight months could churn out some 2.5 million doses—more than a third of the volume Lilly and Regeneron have planned for 2021.
And many drugmakers already safeguard against disruption by manufacturing their most profitable drugs ahead of time and freezing them, Gottlieb said. The government could pursue this strategy by freezing some of the active pharmaceutical ingredient (API) for Lilly and Regeneron’s drugs, storing it away ahead of next winter.
The API would remain stable at freezer temperatures for at least three years and the process of thawing the drug and turning it into a finished product would take less than a month, he said.
Antibody therapies “were always the best bet for reducing the death and suffering from COVID-19 this fall,” Gottlieb wrote. “Yet supply is severely constrained, and the two available drugs must be rationed, somewhat arbitrarily, because the government didn’t do everything possible last spring to ramp up manufacturing.”
Regeneron in August teamed up with Swiss pharma juggernaut Roche to triple production of its antibody cocktail, REGN-COV2—a combination of the monoclonal antibodies casirivimab and imdevimab.
Under the seven-year licensing deal, both companies agreed to reserve manufacturing capacity for the therapy, with Regeneron tackling the U.S. rollout and Roche on deck to handle distribution elsewhere. In late November, the FDA cleared the drug for emergency use in non-hospitalized patients at least 12 years of age who are at high risk for progressing to severe COVID-19.
Lilly, for its part, has enlisted Amgen to assist with production of bamlanivimab, which snared an emergency OK about a week before Regeneron’s cocktail.