HHS, GSK In Strategic Development Alliance

The U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) and GlaxoSmithKline have entered a public-private partnership agreement to develop drugs to combat bioterrorism and antibiotic resistance.

“Working as strategic partners with a portfolio approach offers a new way to move forward in developing a robust pipeline of novel antibiotics that address gaps in our nation’s preparedness as well as the evolving threat of antibiotic resistance,” said BARDA director Robin Robinson, Ph.D.


BARDA and GSK’s antibiotic group will manage and fund the portfolio initially for 18 months and potentially as long as five years. As a cost-share arrangement, HHS will provide $40 million for the 18-month agreement and as much as a total of $200 million if the agreement is renewed. The partners will form an oversight committee for the semiannual review that determines which GSK drug candidates should be included in the portfolio for development.

GSK will conduct safety and toxicology testing, clinical pharmacology studies, clinical studies, and non-clinical studies to support approval to treat illnesses caused by bioterrorism agents like anthrax, plague and tularemia, as well as address antibiotic resistance. One of the antibiotics to be developed under the agreement is GSK’944, which targets bacterial DNA replication. Studies have shown GSK’944 protected or successfully treated animals suffering from anthrax, plague, or tularemia. Additional antibiotic candidates will be incorporated into the program during the first 18 months.

HHS entered into the agreement with GSK using an ‘other transactional authority’ (OTA), which was granted under the Pandemic and All Hazards Preparedness Act of 2006. Although not a contract, grant or cooperative agreement, the OTA provides a funding and collaboration vehicle to promote innovation for advanced R&D.