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From Health Law Daily, September 17, 2015

HHS and AstraZeneca team up, advisory council formed to fight antibiotic resistance

By Mary Damitio, J.D., and Kayla R. Bryant, J.D.

In order to combat the forming “perfect storm” of antibiotic-resistant infections, HHS’s Office of the Assistant Secretary for Preparedness and Response (ASPR) is joining forces with the global biopharmaceutical company, AstraZeneca, to accelerate the development of drugs to treat multi-drug resistant bacterial infections. HHS announced the creation of the public-private partnership agreement, which will work to develop a portfolio of drugs that can be used to treat illnesses caused by both bioterrorism agents and antibiotic-resistant infections. A presidential advisory council, which will include nationally recognized experts appointed by HHS, the Department of Agriculture (USDA), and the Department of Defense (DOD), has also been formed to address the problem of antibiotic-resistant bacteria.

Partnership authority. The partnership was created under the HHS Secretary’s “other transaction authority,” which was granted under the Pandemic and All Hazards Preparedness Act of 2006 (P.L. 109-417). The partnership is the second strategic alliance between ASPR’s Biomedical Advanced Research and Development Authority (BARDA) and a private company. While BARDA has traditionally supported the development of only individual products, HHS states that supporting the development of multiple drug candidates will increase the likelihood of one or more of the drugs advancing to the FDA drug approval stage. According to HHS, the new antibiotics that are developed under the agreement may be available in the commercial marketplace, which would diminish the need to stockpile the drugs for biodefense and would result in the reduction of long-term taxpayer costs.

Drug portfolio. Under the terms of the agreement, BARDA and AstraZeneca will fund and manage the portfolio for the next five years. BARDA will initially provide $50 million toward product development and may provide up to $170 million for additional product development over the five-year period. BARDA and AstraZeneca will conduct joint annual portfolio reviews, during which time drug candidates will be moved in or out of the portfolio based on technical and financial considerations.

First candidate. The portfolio already has its first drug candidate, a combination of two antibiotics, Aztreonam and Avibactam (ATM-AVI), which is being developed to treat Gram-negative infections, for which treatment options are limited. The European Union’s Innovative Medicines Initiative (IMI), which is a similar partnership between the European Union and the European pharmaceutical companies, is supporting a Phase 2 clinical study of ATM-AVI. The IMI will join BARDA and AstraZeneca in funding additional clinical studies for the drug. Additionally, AstraZeneca will study ATM-AVI and other antibiotics for use in treating deadly bioterrorism threats, including meliodosis, glanders and plague.

Antibiotic resistance. The Centers for Disease Control and Prevention (CDC) estimates that antibiotic-resistant bacteria cause two million infections and 23,000 deaths each year, costing the U.S. health care system $35 billion annually. In March, the National Action Plan for Combating Antibiotic-Resistant Bacteria looked to international collaborations and public-private partnerships to create incentives to develop antibiotic resistance treatments. Additionally, the plan also directed BARDA to create at least one additional partnership with a private company by March 2016 to accelerate new antibacterial drug development BARDA Director Robin Robinson, Ph.D., stated, “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.” Robinson added, “We’re using our experience in public-private partnerships and unique legislative authority to rejuvenate the interest of pharmaceutical companies in developing such products.”

Advisory council. The advisory council, which will include physicians, veterinarians, and other experts associated with various universities and organizations across the country, is just one part of the federal scheme to address the problem of bacterial resistance. There is also a National Strategy for Combating Antibiotic-Resistant Bacteria that coordinates investments to prevent, detect, and control outbreaks of these bacterial infections. HHS Secretary Burwell believes that the council will “provide invaluable advice” on the matter.

Companies: AstraZeneca

MainStory: TopStory AgencyNews ClinicalNews DrugBiologicNews PrescriptionDrugNews

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