HHS Adds Two Anthrax Drugs to National Stockpile

Anthim from Elusys Therapeutics and Raxibacumab from GlaxoSmithKilne are monoclonal antibody therapeutics. HHS’ BARDA is spending $54.6 million in support of them, the agency announced Nov. 12.

The U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response announced it is spending a total of $54.6 million to add two anthrax antitoxin drugs to the Strategic National Stockpile for treating inhalational anthrax. They are Elusys Therapeutics, Inc.'s Anthrim and Raxibacumab from GlaxoSmithKline; both are monoclonal antibody therapeutics.

This was Pine Brook, N.J.-based Elusys' first delivery order under a procurement contract for Anthim (obiltoxaximab) and is a five-year agreement valued at $44.9 million. ASPR’s Biomedical Advanced Research and Development Authority (BARDA) has funded advanced development and procurement of Raxibacumab under Project Bioshield since 2009, and it became the first anthrax antitoxin to be approved by the FDA in 2012. Now, BARDA will provide $9.7 million to ensure a continued supply of Raxibacumab to the stockpile through 2019.

"Anthrax remains a bioterrorist threat, and the actions we are taking today will help protect our nation against that threat," said Robin Robinson, Ph.D., director of BARDA. "By expanding the treatment options available within the SNS, we can help meet the diverse needs of the American people in an anthrax-related emergency."

"Since 2002, Elusys has received over $220 million in grants and contracts from the U.S. Department of Defense, National Institutes of Health, and BARDA, representing a unique — and successful — collaboration with three government agencies from early-stage development through submission and acceptance of our Biologics License Application (BLA), and now procurement. This is a major milestone for our company and a significant realization for the U.S. government," said Elizabeth Posillico, Ph.D., president and CEO of Elusys. "Anthim helps the government diversify its anthrax treatment options and provides an important alternative for protecting military, first responders, and U.S. citizens in an emergency. We are very proud to help protect U.S. citizens against the threat of biowarfare."

According to Elusys, anthrax toxin is composed of three proteins secreted by bacteria. The toxins are not affected by antibiotics that target bacterial cells. Obiltoxaximab binds to the protective antigen component of anthrax toxin, one of the three essential components of anthrax toxin that is necessary for bacterial virulence and ability to harm the host. The toxin-neutralizing activity of obiltoxaximab inhibits entry of anthrax toxin into susceptible cells, averting cell and tissue injury, according to the company.

The secretary of Homeland Security determined anthrax to be a material threat to national security in 2004, and it is labeled a "Category A" biowarfare threat by the US government.

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