Multiple drug countermeasures 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’ Office of the Assistant Secretary for Preparedness and Response (ASPR) and biopharmaceutical company AstraZeneca.
“The partnership agreement with AstraZeneca uses Other Transaction Authority granted to the Secretary of HHS under the Pandemic and All Hazards Preparedness Act of 2006,” HHS said in announcing the partnership. “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.”
Within ASPR, BARDA develops and procures medical countermeasures – vaccines, medicines, diagnostics and medical equipment – that address the public health and medical consequences of chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks, pandemic influenza and emerging infectious diseases.
Antimicrobial resistance has been described as the biggest threat to global security.
The Centers for Disease Control and Prevention (CDC) has estimated that in the US, antibiotic-resistant bacteria are responsible for two million infections and 23,000 deaths annually with an estimated annual economic burden of $35 billion on the healthcare system.
“We have a perfect storm forming with a rise in antibiotic resistant infections at a time when most pharmaceutical companies have decreased or halted investment in antibacterial R&D,” BARDA director Robin Robinson, Ph.D. explained. “We’re using our experience in public-private partnerships and unique legislative authority to rejuvenate the interest of pharmaceutical companies in developing such products.”
“This agreement demonstrates our commitment to sustaining the development and approval of new drugs which can help us address our biodefense needs but are also desperately needed to address the rising threat of antibiotic resistance,” Robinson said. “We are especially excited to be working jointly with IMI to promote the development of new antibiotics. Antibiotic resistance is a global problem, and international collaborations must be part of the solution.”
Meanwhile, if America were to be beset by a biological or chemical weapons attack, “The federal government doesn’t have a good answer” for whom would be in charge of responding, according to the consensus of the post-9/11 Commission Blue Ribbon Study Panel on Biodefense during its fourth and final meeting last April.
Furthermore, as Homeland Security Today has repeatedly reported, in the event of a mass casualty terrorist attack or natural disaster that sends floods of victims to regional hospital emergency rooms and trauma units, the risk of antimicrobial resistant – and even antiviral resistant – pathogens would quickly emerge and spread, exacerbating the impact of the event, emergency public health authorities have said.
The National Action Plan for Combating Antibiotic-Resistant Bacteria, released in March 2015, called for establishing international collaborations and public-private partnerships to incentivize the development of new therapeutics to counter antibiotic resistance. The plan also called for BARDA to create at least one additional portfolio partnership with a pharmaceutical or biotechnology company by March 2016 to accelerate development of new antibacterial drugs.
“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 US Food and Drug Administration approval of the drug,” HHS said, noting, “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.”
HHS said 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.”
The first drug candidate in the portfolio combines two antibiotics, Aztreonam and Avibactam, known together as ATM-AVI. This new drug is being developed to treat Gram-negative infections for which there are currently limited treatment options. Under the new partnership, AstraZeneca also will conduct studies evaluating ATM-AVI and other antibiotic candidates for use in treating illnesses caused by deadly bioterrorism threats such as meliodosis, glanders and plague.
The European Union’s Innovative Medicines Initiative (IMI), a partnership between the European Union andthe European pharmaceutical industry, currently is supporting the Phase 2 clinical study of ATM-AVI in Europe under a project called COMBACTE-CARE. The IMI will join BARDA and AstraZeneca in funding additional clinical studies needed to apply for regulatory approval of ATM-AVI.
For more on this issue, read the report, The Fall of Antibiotics … and the Rise of Resistance, in the Aug./Sept. issue of Homeland Security Today.