[editing is mine]
US Department of Health and Human Services
FOR IMMEDIATE RELEASE Friday, May 24, 2013
Advanced research and development is underway for an antibiotic that
potentially could treat children infected with anthrax, tularemia or
community-acquired bacterial pneumonia. The U.S. Department of Health
and Human Services’ Biomedical Advanced Research and Development
Authority (BARDA) will support this advanced research and development
under a two-year, $17.7 million contract with Cempra Pharmaceuticals of
Chapel Hill, N.C.
“The needs of special populations including children are paramount in
public health emergency preparedness,” said BARDA Director Robin
Robinson, Ph.D. “The development of this new antibiotic could help
address a gap in our nation’s preparedness and could bolster clinicians’
ability to treat drug-resistant bacterial infections, which represent a
growing public health threat.”
The contract supports studies needed to request U.S. Food and Drug
Administration (FDA) approval of a drug called solithromycin. If
approved, the drug would be the first orally administrated antibiotic
(taken by mouth) approved in decades to treat children who develop
community acquired bacterial pneumonia. This type of pneumonia is
developed in the community rather than in a hospital.
Studies of the drug’s use in treating anthrax or tularemia will be
conducted under the FDA’s Animal Efficacy Rule and could provide
additional treatment options for clinicians’ use in a public health
emergency involving these bioterrorism infections. The FDA’s Animal
Efficacy Rule allows efficacy findings from adequate and well-controlled
animal studies to support FDA approval when it is not feasible or
ethical to conduct trials in humans.
Solithromycin has demonstrated efficacy in adults with community
acquired bacterial pneumonia and uncomplicated urogenital gonorrhea. In
late 2012, Cempra initiated a global multi-center clinical trial of
orally administered solithromycin in patients with community acquired
bacterial pneumonia. The study will be complete in the first half of
2014, and data from the study will be used, in part, to determine the
advanced research and development activities supported under the
The project with Cempra is one of several new projects supporting antibiotic candidates added to the existing BARDA antimicrobial
drug portfolio this year. 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 a
Broad Agency Announcement BARDA-BAA-12-100-SOL-00011 at www.fbo.gov.
HHS is the principal federal agency
for protecting the health of all Americans and providing essential
human services, especially for those who are least able to help
themselves. BARDA, within the HHS Office of the Assistant Secretary for
Preparedness and Response, provides a comprehensive integrated portfolio
approach to the advanced research and development, innovation,
acquisition, and manufacturing infrastructure for vaccines, drugs,
therapeutics, diagnostic tools, and non-pharmaceutical products for
public health emergency threats. These threats include chemical,
biological, radiological, and nuclear threats, pandemic influenza, and
emerging infectious diseases.
The Office of the Assistant Secretary for Preparedness and Response (ASPR)
is an HHS leader in preparing the nation to respond to and recover from
adverse health effects of emergencies, supporting communities’ ability
to withstand adversity, strengthening health and response systems, and
enhancing national health security.
For more information on national public health and medical preparedness, visit www.phe.gov and to learn more about partnering with BARDA in public health preparedness visit www.medicalcountermeasures.gov.