HHS aids development of next generation broad spectrum antibiotic

The U.S. Department of Health and Human Services today issued a contract for advanced development of a novel antibiotic that potentially could treat illnesses caused by biological threats, such as anthrax and plague, as well as treat bacterial pneumonia and certain life-threatening bacterial infections associated with prolonged hospitalization.

The advanced research and development of the new drug, called TP-434, is being supported under a contract to CUBRC, Inc. of Buffalo, N.Y., in partnership with Tetraphase Pharmaceuticals of Watertown, Mass. The contract, supported and managed by the HHS Biomedical Advanced Research and Development Authority (BARDA), is for $11.4 million in the first year and can be extended an additional four years, for a total of five years and up to a total value of $67.2 million.

Tetraphase Pharmaceuticals currently is developing TP-434, a member of the tetracycline class of antibiotics, to treat complicated intra-abdominal infections. Early research and development indicates that TP-434 also could be effective against bacteria known to be resistant to many other antibiotics, including other tetracyclines approved by the U.S. Food and Drug Administration. Antibiotic resistance is a major concern in the healthcare community as well as a concern in responding to biological attacks.

The BARDA contract will support testing of TP-434 in clinical and animal studies as well as the fine-tuning of drug manufacturing. The contract also supports development of both oral and intravenous formulations of TP-434. Developing TP-434 in both oral and intravenous formulations will make it appropriate for use in severely ill patients who require intravenous treatment and during their recovery when oral therapy is appropriate.

“Protecting the nation against biological threats requires a wide variety of countermeasures, and we’ve found that an efficient way to develop such countermeasures is to focus on products that have both commercial and biodefense uses,” BARDA Director Robin Robinson explained. “This approach was recommended by the Public Health Emergency Medical Countermeasure Enterprise Review which the Secretary released in 2010, and supporting the development of TP-434 reflects our ongoing commitment to multi-purpose products and the expansion of our antimicrobial portfolio for national preparedness.”

TP-434 is the fourth to be funded under the Broad Spectrum Antimicrobials Program led by BARDA. Recognizing the critical linkage to national bioterrorist preparedness, the Pandemic and All Hazards Preparedness Act of 2006 specifically identifies BARDA’s role in the development of broad spectrum antimicrobials. 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-CBRN-BAA-11-100-SOL-00009 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. 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.

Within ASPR, BARDA 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.

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. The Public Health Emergency Medical Countermeasure Enterprise Review is available at http://www.phe.gov/preparedness/mcm/enterprisereview/Pages/default.aspx.