US Senate hearing on plan to research, manufacture and distribute coronavirus vaccine, on Capitol Hill in Washington.
WASHINGTON: The US Department of Justice on Thursday (Jul 23) said it will not stand in the way of efforts by companies, including Eli Lilly and Co and Amgen, to share information to help scale up capacity to manufacture antibody treatments for COVID-19.
In a letter to Lilly, Amgen, AbCellera Biologics, AstraZeneca, Roche Holding’s Genentech unit and GlaxoSmithKline, the DOJ said demand for monoclonal antibodies targeting COVID-19 is likely to exceed what one firm could produce on its own.
The drugmakers are in various stages of developing experimental monoclonal antibodies – manufactured proteins designed to bind to a targeted cell, neutralise it and mark it for destruction by the immune system – for treatment, or even prevention, of COVID-19.
Monoclonal antibodies are among the most common type of biotech medicines, used for cancer, rheumatoid arthritis and many other conditions.
The DOJ did not include Regeneron Pharmaceuticals, which expects to have definitive trial results for its dual-antibody treatment by late summer or early fall.
The Department of Health and Human Services in June awarded Regeneron a US$450 million contract and the company has cleared the way for US manufacturing of its antibody cocktail by moving production of its other products to a plant in Ireland.
“Waiting until regulators approve specific treatments before scaling up manufacturing might delay access to these potentially life-saving medicines by many months,” the agency said in its letter.
The DOJ said the companies have committed not to exchange information related to the prices of any monoclonal antibodies that are eventually shown to be safe and effective and approved for use.
