Information Exchange on Manufacturing COVID-19 Antibodies Gets Green Light From DOJ

The Department of Justice (DOJ) said yesterday it will not stand in the way of pharmaceutical companies sharing information on the manufacturing of monoclonal antibodies for the treatment of COVID-19 patients.

DOJ’s Assistant Attorney General Makan Delrahim said the department does not intend to challenge the proposed conduct described in a July 15 letter from Eli Lilly, AbCellera Biologics, Amgen, AstraZeneca, Genentech and GlaxoSmithKline. He said the DOJ’s leniency in enforcing anticompetition rules will last one year.

“Exchanging this information in this context is unlikely to harm competition because the likely result is that the information exchange will expand output of these critical treatments,” Delrahim said, adding that the information exchange is unlikely to result in collusion in the markets for these treatments nor in monoclonal antibody treatments for other conditions, such as cancer or rheumatoid arthritis.

Numerous antibody studies for potential COVID-19 treatments are in the works. On June 1, Eli Lilly announced that the first patients had been dosed in a phase 1 study of LY-CoV555, the lead antibody from the company’s collaboration with AbCellera, and a week later, the drugmaker announced that the first healthy volunteer had been dosed with JS016, the lead antibody from Lilly’s collaboration with Junshi Biosciences.

The National Institutes of Health (NIH) highlighted the potential of monoclonal antibodies in a strategic plan to fight COVID-19 published this month, noting that they are among several promising therapeutic approaches that boost the immunity of people infected with the coronavirus.

“NIH researchers and partners from across the globe have begun isolating, cloning, producing and evaluating such protective, neutralizing antibodies from people who have recovered from COVID-19. Some of these monoclonal antibodies already are on a pathway to clinical testing,” the NIH said.

Red the DOJ’s letter to the drugmakers here: www.fdanews.com/07-24-20-Letter.pdf. — Martin Berman-Gorvine