The Department of Justice (DOJ) will let drug manufacturers share details on capacity, raw materials and supplies so that they can collaborate, given that demand for a successful antibody to treat COVID-19 could outstrip any one company’s ability to supply it, according to a July 23 business review letter to six manufacturers.
The companies cannot, however, share information related to the prices of the treatments, commercial terms of arrangements for the raw materials and supplies, or cost for the inputs or the production of the therapies.
“The demand for monoclonal antibodies targeting COVID-19 is likely to exceed what any one firm could produce on its own,” the DOJ said in a press statement accompanying the letter. “Moreover, waiting until regulators approve specific treatments before scaling up manufacturing might delay access to these potentially life-saving medicines by many months, which adversely could affect the nation’s efforts to fight COVID-19.”
Typically, companies that share such information with one another could run afoul of antitrust issues because the collaboration could lead to collusion and reduced output, the DOJ said. However, in this instance, the information sharing is likely to have the opposite effect, the department concluded.
The DOJ also said the collaboration would not affect competition for the markets in which the companies manufacture other monoclonal antibodies (mAbs) because the companies will not disclose their total production capacity. Instead, each will decide independently how much capacity they will dedicate to COVID-19 mAbs.
The companies requested the review on July 15 under the expedited temporary review procedure outlined in a March joint antitrust statement regarding COVID-19 from the DOJ and the Federal Trade Commission. The pathway is designed to evaluate COVID-19-related business review requests within seven calendar days.
There are more than 40 mAbs in the clinic to treat COVID-19. But, because of the manufacturing complexities and the limited number of facilities that can produce them at scale, there is growing concern that the existing capacity will not be able to satisfy the global demand if any treatments prove effective.
An analysis of production capacity by the Duke-Margolis Center for Health Policy found that with COVID-19 therapeutics, these resources could be stretched to the limit.
Based on the current rates of infection, hospitalization and symptomatic cases of SARS-CoV-2 infections, and assuming just one dose per infected patient, the group estimated that over 25 million doses of a therapeutic mAb could be needed. That would require an almost 50% increase in manufacturing output from 2019, when 53 million therapeutic mAbs were sold in the US.
The researchers also analyzed the bioreactor capacity in the US and found that an overwhelming majority of it was used for in-house manufacture of therapeutic antibodies, meaning that companies will have to collaborate to share infrastructure for COVID-19 manufacturing.
In addition to working with the DOJ to address potential antitrust issues, the researchers recommended that the federal government play a coordinating role, similar to what it’s doing with vaccine research and manufacturing, and that consideration be given to expanding manufacturing capacity on a short-term basis via replicate, single-use modular platforms or other methods.