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U.S. Department of Health and Human Services

May 22, 2013: HHS forms strategic alliance to develop new antibiotics

Date: May 22, 2013 

Company: GlaxoSmithKline of North Carolina

Contract amount: This agreement is not a contract; other transactional authority was used to create a strategic alliance. BARDA will contribute $40 million over 18-months. The agreement can be extended up to five years and up to a total of $200 million

 

About the contract: The agreement is the first in which BARDA has taken a portfolio approach with a private sector company instead of contracting to develop a single medical countermeasure. The agreement is flexible, allowing drug candidates to be moved in or out of the portfolio, based on advanced development stage and technical considerations, during joint semi-annual portfolio reviews. Under the agreement, GSK researchers 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 further developed under this agreement is GSK’944, the first in class of drugs that targets bacterial DNA replication in a unique fashion. GSK has conducted studies in which GSK’944 protected or successfully treated animals suffering from anthrax, plague, or tularemia.

Additional information: The partnership with GSK is funded by BARDA’s Broad Spectrum Antimicrobials Program. BARDA is seeking additional proposals for broad-spectrum antimicrobials that could potentially treat or prevent illness due to biological threat agents. Proposals are accepted through the Broad Agency Announcement BARDA-BAA-12-100-SOL-00011 at www.fbo.gov.

Press Release: HHS forms strategic alliance to develop new antibiotics