The market for biodefense countermeasures has grown dramatically as a result of the increased awareness of the threat of global terror activity in the wake of the September 11, 2001 terrorist attacks. The U.S. government is now the largest source of development and procurement funding for academic institutions and biotechnology companies conducting biodefense research to treat chemical, biological, radiological or nuclear threats.
There are three primary markets for medical countermeasures:
- U.S. Civilian: The U.S. civilian market includes funds to protect the U.S. population from biological agents and is largely funded by the Pandemic All-Hazards Preparedness Reauthorization Act of 2013 (“PAHPRA”). Passed by Congress in 2013, PAHPRA reauthorizes the work begun under the Project BioShield Act of 2004 and the Pandemic and All-Hazards Preparedness Act of 2006. In particular, the act reauthorizes the Special Reserve Fund at $2.8 billion for five years. The SRF is administered by BARDA and used to purchase medical countermeasures for the Strategic National Stockpile. The majority of BARDA procurements to date have been made prior to FDA approval using the Emergency Use Authorization pathway.
- U.S. Military: The DoD is responsible for the development and procurement of countermeasures for the military segment which focuses on providing protection for military personnel and civilians who are on active duty. In general, research and development funding has been transitioned to BARDA in recent years as DoD budgets have been targeted for reduction.
- Non-U.S. Markets: Non-U.S. markets address protection against biowarfare agents for both civilians and military personnel in foreign countries. We anticipate that foreign countries will want to procure biodefense products as they are developed and validated by procurement by the U.S. government. If sales of AEOL 10150 commence under an Emergency Use Authorization, it will be necessary to address regulatory regimes for the use of unapproved drugs, if any, in each country individually.
History of Biodefense
Project BioShield became law in 2004 and authorized the procurement of countermeasures for chemical, biological, radiological and nuclear attacks for the Strategic National Stockpile. Project BioShield provided appropriations of $5.6 billion to be expended over ten years.
The Pandemic and All-Hazards Preparedness Act (“PAHPA”), passed in 2006, established BARDA as the agency responsible for awarding procurement contracts for biomedical countermeasures and providing development funding for advanced research and development in the biodefense arena, and supplemented the funding available under Project BioShield for chemical, biological, radiological and nuclear countermeasures. These programs were reauthorized for an additional five years in 2013 under the Pandemic All-Hazards Preparedness Reauthorization Act.
Funding for BARDA and the Special Reserve Fund is provided by annual appropriations by Congress within the parameters set by PAHPRA.