Project BioShield

Medical Countermeasures with Broad Spectrum Activities
The Threats

The U.S. Department of Health and Human Services has a requirement to develop broad spectrum antimicrobials for the following biological threat agents: Bacillus anthracis, Yersinia pestis, Francisella tularensis, Burkholderia mallei, Burkholderia pseudomallei, Rickettsia prowazekii, orthopoxviruses, filovirus, and Arenavirus (Junin virus). The Biomedical Advanced Research and Development Authority (BARDA) is expanding its role in the development of these medical countermeasures by concurrently providing funding to develop novel therapies to address the public health threat of naturally occurring antibiotic/antiviral resistance.

Broad Spectrum Antimicrobials Medical Countermeasure Efforts

The Broad Spectrum Antimicrobials (BSA) program is actively seeking collaboration through public-private partnerships. Through these agreements, BARDA supports the development of candidate products for commercial use in addition to the advanced research and development activities supporting biodefense indications. This nondilutive funding strategy provides our partners with capital to support product development and supplements existing equity.

Advanced Research and Development Funding

BARDA is funding advanced research and development for broad spectrum antimicrobials using yearly congressional appropriations. The advanced research and development funds are distinct from the Project Bioshield Special Reserve Fund. Advanced research and development funds support products through the "valley of death" with the intent to build a sustainable medical countermeasure pipeline for future Project Bioshield procurements.

The BSA program is responsible for incentivizing the antimicrobial product pipeline with the goal to increase ongoing research and development of broad spectrum products that are effective against biodefense pathogens as well as antimicrobial resistant, clinically prevalent, infectious diseases. In an effort to engage all industry partners, the BSA strategy includes supporting commercial development in tandem with biodefense development. Through the support of preclinical and clinical studies and manufacturing activities, the BSA program will expedite antimicrobial development. This strategy has the potential to increase the robustness of the developmental pipeline to address both naturally occurring antimicrobial resistance and bioterrorism threat agents.

The BSA program has funded the following contract(s) through the BARDA Broad Agency Announcement (BAA) (BARDA-CBRN-BAA-00009) and anticipates funding additional contracts on a quarterly basis:

  • August 30, 2010: Achaogen, Inc. (ACHN-490) - A $26 million, 2-year contract with options that support the development of a novel, next-generation aminoglycoside antibiotic to treat plague, tularemia infections as well as complicated urinary tract infections, and ventilator-acquired pneumonia.
  • February 16, 2011: Chimerix, Inc. (CMX-001) - A $24.8 million, 1-year contract with options that support the development of a broad spectrum antiviral with potential dual utility against variola virus (causative agent of Smallpox) and double-stranded DNA (dsDNA) viruses like adenovirus, cytomegalovirus, and BK virus.
  • May 5, 2011: SIGA Technologies, Inc. (ST-246) - National Institute of Allergy and Infectious Diseases (NIAID) transitioned the SIGA advanced research and development contract supporting "Expanded Utility and Additional Indications" for the novel therapeutic agent against smallpox disease to BARDA in May 2011. BARDA is now managing the contract awarded by NIAID in September 2008.   BARDA is providing technical and financial support towards the development of an intravenous (I.V) formulation and post-event prophylactic (PEP) treatment indication for ST-246.
  • May 13, 2011: SIGA Technologies, Inc. (ST-246) - A $433 million, 5-year contract with options that support the development and procurement of 1.7 million treatment courses of a novel therapeutic agent against variola virus (causative agent of Smallpox).  This contract for late stage development and procurement is funded through Project Bioshield.
  • September 6, 2011: GlaxoSmithKline, LLC (GSK2251052) - A $38.5 million, 2-year contract with options that support the development of a novel first-in-class leucyl tRNA synthetase inhibitor.   GSK'052 will be developed for biodefense applications including prophylaxis and treatment of infections caused by B. anthracis, F. tularensis, and Y. pestis.   In parallel, GSK'052 will also be developed to treat complicated urinary tract infections, complicated intra-abdominal infections, and hospital- or ventilator-acquired pneumonia.

Industry partners are encouraged to visit the BARDA BAA and sign up for a tech watch meeting.