GlaxoSmithKline and Vir Biotechnology are rushing to speed up production of their COVID-19 therapy, now that they’re the only companies with an antibody that appears to be truly effective against omicron.
The FDA on Dec. 30 cleared a Samsung Biologics site as a second manufacturing facility to make GSK and Vir’s Xevudy (sotrovimab), a GSK spokesperson told Fierce Pharma.
Along with adding the new facility, GSK and Vir worked with external partners to secure additional batches of drug substance to support supply this year, the spokesperson said via email.
GSK had been planning to commission a new production facility to scale up production and establish a second manufacturing site amid pandemic uncertainty, the spokesperson said. But omicron’s emergence suddenly pushed the acceleration button.
GSK and Vir recently found that sotrovimab retains its strength against omicron in cell cultures, while lab data showed that Eli Lilly’s antibody combo of bamlanivimab and etesevimab and Regeneron’s REGEN-COV cocktail are unlikely to be able to tackle the new variant.
That means, among the three FDA-authorized antibody drugs to treat infected patients, only sotrovimab is still powerful enough to fight omicron. AstraZeneca’s Evusheld is authorized as a prevention method for immuno-compromised people.
After those lab tests, the U.S. government in December temporarily halted distribution of Lilly’s and Regeneron’s offerings. Although the two products are now shipping again, their ability to fight the now-dominant omicron remains questionable.
Demand naturally started to shift to Xevudy. Last week, the Biden administration signed a deal to buy 600,000 additional doses for distribution this quarter.
“We were on the phone with the U.S. government immediately, sharing the data, discussing what was possible from a supply perspective,” said Bart Murray, who leads GSK’s COVID operation in the U.S., as quoted by The Wall Street Journal.
Other countries have also been snagging supplies of Xevudy. A few days ago, Canada signed on for 20,000 doses. GSK also has agreements with Japan, U.K., Singapore, Australia and others. All told,
GSK and Vir have said they expect to manufacture about 2 million doses globally in the first half of 2022.
Before the new deal, GSK had delivered the 440,000 doses it agreed to supply to the U.S. in 2021. The government is still allocating that supply to healthcare facilities. The company now expects to start shipping the 600,000 doses in February and March, the spokesperson said.
Both Regeneron and Eli Lilly have started developing new antibody treatments that could neutralize omicron.
Meanwhile, China’s Brii Biosciences is seeking an FDA green light for its antibody combo of amubarvimab and romlusevimab, which won Chinese approval in December. The company recently said its cocktail also held up against omicron. The U.S. doesn’t yet have any supply agreement with Brii.