Multiple drugs to combat bioterrorism threats and other life-threatening bacterial infections will be developed under a public-private partnership agreement between the Department of Health and Human Services (HHS), its Office of the Assistant Secretary for Preparedness and Response (ASPR), and AstraZeneca, a global biopharmaceutical company.
The partnership agreement with AstraZeneca uses Other Transaction Authority granted to the HHS secretary of HHS under the Pandemic and All Hazards Preparedness Act of 2006. The agreement becomes the second such strategic alliance ASPR’s Biomedical Advanced Research and Development Authority (BARDA) has forged with a private company to develop a portfolio of drug candidates with dual uses in treating illnesses caused by bioterrorism agents and antibiotic-resistant infections.
Traditionally, BARDA supports development of individual products. Supporting development of multiple drug candidates increases the likelihood that one or more will advance to the level at which the company can apply for Food and Drug Administration (FDA) approval of the drug. In addition, novel antibiotics developed under the agreement may become available in the commercial marketplace, which diminishes the federal government’s need to stockpile these products for biodefense and reduces long-term costs for taxpayers.
BARDA and AstraZeneca will manage and fund the portfolio over the next five years. In the cost-sharing arrangement, BARDA initially will provide $50 million toward product development and could provide up to a total of $170 million for development of additional products in the portfolio during the five-year period. During joint annual portfolio reviews, BARDA and AstraZeneca will determine which drug candidates move in or out of the portfolio based on technical and financial considerations and each drug candidate’s development progress.