GlaxoSmithKline Races to Fill Gap in Supply of Antibody Drug

"GlaxoSmithKline PLC and partner Vir Biotechnology Inc. are straining to meet soaring demand for their Covid-19 antibody treatment after the highly mutated Omicron variant knocked out the two competing products.

Demand has jumped in recent weeks for the treatment, called sotrovimab, because it is the only antibody drug authorized in the U.S. for the newly infected that has been found to work against Omicron.

Glaxo and Vir, which were using one manufacturing plant, say they have raced to add another and taken other steps to roughly double the number of doses they can deliver to the U.S. in the first quarter to 600,000.

The federal government purchases doses, which it distributes to state health departments based on need. Last week, the Biden administration agreed to pay $945.1 million for the 600,000 doses.

The companies expect deliveries to start in February, which doctors say should help to ease the U.S. shortages, though supplies still won't be enough.

"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 Glaxo's Covid-19 business in the U.S.

Other countries are also seeking to lock up more sotrovimab doses. Australia said early this month it had reached a deal for about 45,000 doses, nearly doubling its supply. Around the same time, Canada secured 20,000 doses, adding to an earlier order for 10,000.

The scramble to expand manufacturing underscores the challenges that health authorities and drugmakers face staying ahead of an evolving virus as they roll out drugs and vaccines.

Antibody drugs are designed to mimic a part of the body's natural immune response to Covid-19. Since first going into use in November 2020, the therapies have played an important role in pandemic treatment.

Doctors have been giving the drugs, which are administered by IV infusion, to people who are at high risk of severe disease shortly after infection, to cut the chances they will need to be hospitalized.

Three of the drugs -- the other two made by Regeneron Pharmaceuticals Inc. and Eli Lilly & Co. -- were authorized in the U.S. for use in people soon after infection at high risk of severe disease. A fourth, made by AstraZeneca PLC, has been authorized for preventive use in people with weakened immune systems, more akin to a vaccine.

Before Omicron, the U.S. relied more heavily on the Regeneron and Lilly products.

In the three months to Dec. 12, the federal government distributed 1.1 million courses of Regeneron's and 582,072 courses of Lilly's cocktail, compared with 179,880 courses of sotrovimab, according to data from the U.S. Department of Health and Human Services.

That left a huge supply hole for Glaxo and Vir to fill when Omicron emerged, because the new variant can evade the Regeneron and Lilly drugs.

"For the world, it'd be better if they all kept activity. We know we don't have enough, and we can't supply the need," said Vir Chief Executive George Scangos.

Two newly authorized Covid-19 pills, from Pfizer Inc. and from Merck & Co. and partner Ridgeback Biotherapeutics LP, also have been found to work against Omicron, but they are in short supply as the companies increase production.

"While we're doing everything we can to treat as many patients as possible, it's so overwhelming, the numbers right now," said Amanda Peppercorn, who leads Covid-19 antibody development at Glaxo.

In Texas, where case numbers are nearly quadruple the levels during the Delta peak, demand is outstripping supply by around 10 times. That shortage is leading hospitals to ration doses of sotrovimab for the most at-risk patients." [1]

1. U.S. News: GlaxoSmithKline Races to Fill Gap in Supply of Antibody Drug
Roland, Denise. Wall Street Journal, Eastern edition; New York, N.Y. [New York, N.Y]. 22 Jan 2022: A.6.