The U.S. Department of Health and Human Services (HHS) announces new details of its agreement with Regeneron to extend its public-private partnership to develop life-saving monoclonal antibodies as part of Project NextGen enhancing our preparedness for COVID-19 strains and variants.
The HHS is committed to lowering drug costs for all Americans. As part of that commitment, HHS and Regeneron announced an extension of their long-standing partnership to develop life-saving monoclonal antibodies. That modification to Regeneron’s contract with the Administration for Strategic Preparedness and Response’s (ASPR’s) Biomedical Advanced Research and Development Authority, is valued at $326M and supports the advanced development of a next generation monoclonal antibody for COVID-19 prevention under HHS’s Project NextGen.
This agreement included a clause where Regeneron committed that if a new product is commercialized, its list price in the United States will be equal to or less than its retail price in comparable markets globally. Inclusion of this clause is the result of HHS’s and Regeneron’s shared interest in ensuring enduring and equitable access to therapeutics developed under public-private partnerships for all Americans. An excerpt of this clause is provided below.
If Regeneron commercializes a product in the United States for prevention of SARS-CoV-2 comprised solely of a COVID-19 therapeutic for which BARDA invests [a minimum amount or more] under this Agreement, then, subject to applicable law, the list price (at wholesale acquisition cost) for commercial sales of such product in the United States following full licensure of the product, shall be substantially equivalent to or less than the approved price for commercial sales in High Income Countries outside of the United States; provided that such sales are comparable sales taking place within the same time period. Regeneron is permitted to take into account all relevant factors in determining whether sales are comparable sales, including volume commitments, timing of purchase and supply, the terms and conditions of purchase and supply, market conditions and epidemiology of SARS-CoV-2.
The Biden-Harris Administration would like to publicly thank Regeneron and ASPR for their leadership in advancing this critical Administration priority.
If you would like to learn more about Project NextGen, please visit medicalcountermeasures.gov/nextgen/.