HHS enters strategic alliance with AstraZeneca to accelerate new antibiotic development

Anglo-Swedish pharma major AstraZeneca (LSE: AZN) has joined with the US Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) in a public-private partnership to develop multiple drugs to combat bioterrorism threats and other life-threatening bacterial infections.

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.

BARDA could provide up to $170 million

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 this US agreement, the company will also 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 II clinical study of ATM-AVI in Europe under a project called COMBACTE-CARE (The Pharma Letter March 25). The IMI will join BARDA and AstraZeneca in funding additional clinical studies needed to apply for regulatory approval of ATM-AVI.