Multiple drugs to combat bioterrorism threats and other life-threatening bacterial infections will be developed under a public-private partnership agreement between the U.S. Department of Health and Human Services' 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 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 U.S. Food and Drug Administration 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.

The first drug candidate in the portfolio combines two antibiotics, Aztreonam and Avibactam, known together as ATM-AVI. The new drug is being developed to treat Gram-negative infections for which there are currently limited treatment options. Under today's agreement, the company 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 and the 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.

"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," said BARDA director Robin Robinson, Ph.D. "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."

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.

CDC has estimated that in the U.S. 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," Dr. Robinson 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."

9/16/15