|FOR IMMEDIATE RELEASE
Tuesday, June 25, 2013
Contact: HHS Press Office
BARDA supports new broad-spectrum antibiotic
Drug could be first against two bioterrorism threats as well as common drug-resistant infections
|To protect the public against two bioterrorism threats, melioidosis and glanders, the U.S. Department of Health and Human Services will support the advanced research and development of a new antibiotic called BAL30072. If approved by the U.S. Food and Drug Administration, BAL30072 would be the first antibiotic approved to treat these bioterrorism threats and could provide new options for treating other severe infections caused by antibiotic-resistant bacteria.
Melioidosis, also called Whitmore's disease, can be mistaken for other diseases such as tuberculosis and common forms of pneumonia. The bacteria that causes melioidosis can be found in water and soil and cause infection when a person touches or inhales the bacteria. Glanders is a respiratory disease that can affect humans, although it is primarily found in animals. The bacteria that cause glanders can affect skin, blood, lungs, or muscles and may be transmitted through direct contact with infected animals or by inhaling contaminated aerosols or dust.
“Increasing the pipeline of products available to respond to bioterrorism threats is a top priority,” said Robin Robinson, Ph.D., director of the Biomedical Advanced Research and Development Authority (BARDA), which will oversee the program. “In addition, antibiotic resistance poses an increasing risk to public health and could impact our nation’s ability to respond effectively to a bioterrorism attack."
HHS will support the advanced research and development of BAL30072 through contract with Basilea Pharmaceutica International Ltd., a pharmaceutical company headquartered in Basel, Switzerland. The contract creates a cost-sharing public-private partnership between BARDA and Basilea that can be extended up to a total of six years. Under this partnership, BARDA will contribute $16.8 million in the first phase of the program to develop BAL30072 and up to a total of $89 million if the contract is extended for the full six years.
In addition to showing promise in treating melioidosis and glanders, early studies of BAL30072 have demonstrated the drug’s potential in treating a broad range of multidrug-resistant Gram-negative bacteria commonly found in hospitals. Gram-negative bacteria are one two common groups of bacteria distinguished by the structures of their cell walls. The majority of Gram-negative bacteria cause disease.
The drug also has shown promise as part of a combination therapy with other licensed antibiotics in treating severe infections including hospital-acquired pneumonia, complicated intra-abdominal infections, cystic fibrosis lung infections, and complicated urinary tract infections.
Under the contract, BARDA will support Basilea to conduct studies evaluating the safety and efficacy of BAL30072 to treat Gram-negative infections including melioidosis, glanders, hospital-acquired pneumonia, and complicated urinary tract infections. Results from these studies will support the eventual filing of a new drug application with the FDA.
The contract is funded under BARDA’s Broad Spectrum Antimicrobials Program and is the third public-private agreement forged this year to support development of new classes of antibiotics and the fifth since the program began in 2010.
The first was an innovative partnership with GSK to support a portfolio of antibiotic candidates
, and the second was with Cempra
to support the development of solithromycin to treat community acquired bacterial pneumonia, anthrax and tularemia. These new drugs in development complement BARDA’s existing projects with Achaogen
and CUBRC/Tetraphase, adding to a diverse portfolio of candidate antibiotics to treat infections from bioterrorism agents and drug-resistant infections.
BARDA is seeking additional proposals for broad-spectrum antimicrobials that potentially could treat or prevent diseases caused by bacterial and viral threat agents, and clinically relevant emerging and drug resistant pathogens that through the Broad Agency Announcement BARDA CBRN BAA-12-100-SOL-00011
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
) leads the efforts 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.
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