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news.Elusys Therapeutics has been awarded its first delivery order under a procurement contract for Anthim (obiltoxaximab), an investigational agent for the treatment of inhalational anthrax infection, valued at $44.9M.
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The delivery order was issued by the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (HHS ASPR), for acquisition of Anthim into the Strategic National Stockpile (SNS) as a countermeasure against a potential bioterrorist attack.
Elusys president and CEO Elizabeth Posillico said: "Since 2002, Elusys has received over $220 million in grants and contracts from the U.S. Department of Defense (DoD), National Institutes of Health (NIH) 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.
"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."
The U.S. Food and Drug Administration (FDA) is currently reviewing Elusys’ Biologics License Application (BLA) for the liquid formulation of Anthim for the treatment of inhalational anthrax in combination with appropriate antibiotics and prophylaxis when alternative therapies are not available or are not appropriate. Inhalational anthrax is a top bioterror threat. Anthim was granted Fast-Track status and Orphan Drug Designation by the FDA.
Inhalation anthrax is a life-threatening infectious disease caused by the bacterium Bacillus anthracis. Much of the morbidity and mortality of anthrax can be attributed to anthrax toxins. Inhaled anthrax is often fatal, despite treatment with antibiotics.
In the 2001 anthrax letter attacks, inhalational anthrax had a fatality rate of approximately 45% in humans infected, even when victims were given antibiotics and supportive hospital care. Under current guidelines, CDC recommends the use of anthrax antitoxins with antibiotics in cases where there is a high level of clinical suspicion for systemic anthrax.