BARDA supports first Project BioShield contract for smallpox drug
Contract funds late-stage development, future acquisition of antiviral drug to treat smallpox
May 13, 2011: The Biomedical Advanced Research and Development Authority (BARDA) today announced a five-year, $433 million contract for late-stage development of an antiviral drug to treat individuals infected with smallpox. The contract with SIGA Technologies Inc., of New York City also includes procurement of 1.7 million treatment courses of the drug, ST-246, within five years.
Today’s contract is the first for smallpox antiviral drug development to be supported through Project BioShield, managed by BARDA within the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response.
The contract supports the final stages of ST-246 drug development needed to apply for U.S. Food and Drug Administration approval, including the development of techniques for scale-up manufacturing, a Phase III safety study which tests the drug in a large number of healthy human volunteers to be sure there are no adverse reactions to the drug, and studies in animals to demonstrate product efficacy.
Under the contract, the company also will develop a pediatric oral formulation of the drug, in compliance with requirements of the Pandemic and All-Hazards Preparedness Act of 2006.
Project BioShield, as amended by the Pandemic and All-Hazards Preparedness Act, provides additional and more flexible authorities and funding to support and expedite the development and acquisition of medical countermeasures against chemical, biological, radiological, and nuclear threats.
The work that will take place under this contract will build upon the initial drug research and development supported by the National Institute of Allergy and Infectious Diseases and the U.S. Department of Defense. This initial work, with support from the Centers for Disease Control and Prevention, and with World Health Organization assent, demonstrated effectiveness against the live variola virus, which causes smallpox. ST-246 is the first antiviral drug to transition from such support to BARDA for to continued development onward to ward acquisition and regulatory approval licensure under the Project BioShield Act of 2004.
“Today’s contract represents an important milestone in the path from discovery to approval of a medical countermeasure against a potentially deadly bioterrorism threat,” said Dr. Robin Robinson, deputy assistant secretary for preparedness and response and BARDA director. “Adding antiviral drugs to the health care provider's toolbox is an important part of being prepared for bioterrorism. Antiviral drugs can save lives so we look forward to the final stages of development and future acquisition of this product.”
Routine smallpox vaccination ended in the United States in the early 1970s, so people born after routine vaccination ended are not immune to the disease. If the virus were used in a bioterrorism attack, HHS estimates that up to 1.7 million people or more could need treatment.
Although the Strategic National Stockpile (SNS) includes smallpox vaccine, vaccines only protect against disease if a person is vaccinated before or very soon after being exposed to the virus. Historically, approximately one-third of people who become ill with smallpox died from the virus. ST-246 is being developed to treat people who already have smallpox symptoms.
The U.S. strategy includes having two smallpox antiviral drugs for protecting the public against intentional or unintentional release of the smallpox virus. The development of these drugs supports not only U.S. national health security, but also global public health security, since any confirmed case of smallpox in the world would become a cause for international concern.
Today’s contract is part of BARDA’s comprehensive integrated portfolio approach to the advanced research and development, stockpile acquisition, innovation, and manufacturing infrastructure for medical countermeasures. BARDA supports development and acquisition of the necessary vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products such as ventilators for public health and medical emergencies including chemical, biological, radiological and nuclear treats, pandemic influenza, and emerging infectious diseases.
The SNS, operated by the CDC, has large quantities of medicine and medical supplies to protect the American public if there is a public health emergency, such as a terrorist attack or flu outbreak, severe enough to cause local supplies to run out. Once federal and local authorities agreed that the SNS supplies were needed medicines could be delivered to any state in the U.S. within 12 hours. Each state has plans to receive and distribute SNS medicine and medical supplies to local communities as quickly as possible.
For more information about BARDA and ASPR preparedness efforts for public health and medical emergencies, including Project BioShield contracts, visit www.phe.gov. More information about the Strategic National Stockpile is available at http://www.cdc.gov/phpr/stockpile.htm.
# # #
Note: All HHS press releases, fact sheets and other press materials are available at http://www.hhs.gov/news.