The nation’s supply of anthrax antitoxin will be maintained until 2018 under Project BioShield contracts issued by the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR). Orders placed today will replenish the stockpile of anthrax antitoxin as doses currently in the Strategic National Stockpile expire. The contracts also establish, for the first time, a surge capacity to produce antitoxin if an anthrax attack occurs.
Project BioShield is the chief mechanism through which the U.S. government supports the advanced development and procurement of new medical countermeasures – drugs, vaccines, diagnostics, and medical supplies – to protect health against chemical, biological, radiological and nuclear threats.
Through the Project BioShield Act of 2004, ASPR’s Biomedical Advanced Research and Development Authority (BARDA) has supported the development and procurement of two anthrax antitoxins to treat people with anthrax disease and an anthrax vaccine, as well as drugs or medical products to protect health against smallpox, botulism, and radiation injury.
“Project BioShield’s long-term funding and planning encourage companies to partner with the federal government on products like anthrax antitoxin that they otherwise would not pursue, but that our nation would need in a crisis,” said BARDA Director Robin Robinson, Ph.D. “The acquisition of additional anthrax antitoxin to replenish expiring stocks will provide for greater national health security against this threat through 2018 and beyond.”
Anthrax antitoxins, vaccine and antibacterial drugs will be needed to protect health in an anthrax attack. In 2001, when anthrax-laden letters were sent through the mail, antibacterial drugs were the only products available to treat people who had been exposed to anthrax but were not yet showing signs of illness.
HHS awarded the Project BioShield contracts, valued a minimum of $100,000, to Cangene Corporation of Winnipeg, Canada; Elusys Therapeutics Inc. of Pine Brook, N.J.; Emergent Product Development of Gaithersburg, Md.; GlaxoSmithKline in Research Triangle Park, N.C., and PharmAthene of Annapolis, Md.
Under these contracts, HHS will order approximately $196 million in antitoxin from GlaxoSmithKline. In addition, HHS will purchase materials to manufacture antitoxin. The materials include blood plasma from Cangene for approximately $63 million and a total of $1.6 million in cells from GlaxoSmithKline, PharmAthene, and Emergent. PharmAthene and Emergent have antitoxin at earlier stages of development than the GlaxoSmithKline and Cangene products.
Today’s actions build on efforts by all five companies and the federal government to develop anthrax antitoxins. Human Genome Sciences (acquired by GlaxoSmithKline) and Cangene began delivering antitoxin to the stockpile in 2009 and 2007, respectively.
The U.S. Food and Drug Administration (FDA) approved GlaxoSmithKline’s Raxibacumab, in December 2012 to treat inhalational anthrax in combination with other antibiotics in people exposed to anthrax spores. The drug also is approved to prevent inhalational anthrax infection when alternative therapies are not available or cannot be used. Cangene’s Anthrax Immune Globulin Intravenous (AIGIV) could be used with emergency use authorization from the FDA. The development of both products was supported by Project BioShield funds.
To create surge capacity, the contracts allow HHS to place future delivery orders if an anthrax attack occurs, in addition to replenishing the current stockpile as needed over the next five years. The cost of future orders would be determined on a case-by-case basis, up to a maximum of $350 million per order. To receive a future order, the company must have antitoxin that is eligible for emergency use authorization or is FDA-approved at the time of the order.
The replenishment and surge capacity are part of a governmentwide effort to prepare the nation to respond to security threats from chemical, biological, radiological or nuclear weapons. Federal agencies, including HHS agencies and the departments of Homeland Security, Defense, and Veterans Affairs coordinate closely to ensure programs and requirements are aligned.
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. In addition to chemical, biological, radiological, and nuclear weapons, and these threats include pandemic influenza and emerging infectious diseases.