A crisis has arisen from the simultaneous decrease in the
number of pharmaceutical companies developing antibiotics and the dramatic
increase in the prevalence of infections and deaths caused by antibiotic
resistant pathogens. Due to the genetic promiscuity of bacteria, the same
genetic markers that give rise to antibiotic resistance in hospital acquired
infections can be transferred to biothreat pathogens (e.g. Y. pestis, B.
anthracis, F. tularensis, B. mallei and/or B. pseudomallei).
Therefore, the threat of naturally-occurring or
intentionally-engineered antibiotic-resistant biothreat pathogens potentially
impacts the effectiveness of the current stockpile of antibiotic medical
countermeasures (MCMs) to treat these threats.
The year-over-year increase in hospital and community
acquired bacterial infections due to antibiotic resistant bacteria and the
transmissibility of these resistant markers to sensitive bacteria represents a
serious threat to the national health security of the United States. These
health challenges also place a substantial health and economic burden on our
society and will continue to do so if not adequately addressed.
Using Project BioShield funds, the Biomedical Advanced
Research and Development Authority (BARDA) seeks to develop candidate
antibiotics which have received marketing authorization from the U.S. Food and
Drug Administration (FDA) for a pulmonary indication or are in Phase 3 clinical
development for a pulmonary indication, and eligible for Emergency Use
Authorization (EUA) pre-approval by FDA for a biothreat indication. If the
antibiotic does not have FDA marketing authorization for a pulmonary
indication, the Offeror must seek development and FDA marketing authorization
for a pulmonary indication that could support EUA pre-approval or marketing
authorization for a biothreat indication.
BARDA will also support the necessary late-stage development
to complete the regulatory pathway for a biothreat indication for the antibiotics
being procured (if applicable) and efforts related to post-marketing
Supporting the development and stockpiling of medical
countermeasures that treat antibiotic resistant bacteria including biothreats
will augment the U.S. response to any biothreat agent or public health
Additional details are available via Solicitation Number: 19-100-SOL-00011.