PINE BROOK, NJ, NOVEMBER 12, 2015 – Elusys Therapeutics, Inc. (Elusys) today announced it 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. 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.
“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,” said Elizabeth Posillico, PhD, President and Chief Executive Officer 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.”
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.
Anthim is a high-affinity monoclonal antibody in development for the treatment and prevention of inhalational anthrax, a top bioterror threat. Anthim is the only anthrax anti-toxin in advanced stages of development that is being investigated for intravenous (IV) treatment and prophylaxis and intramuscular (IM) prophylaxis administration. IV administration is being evaluated for the treatment of patients who have established infection and are symptomatic for anthrax disease, as well as for prophylaxis. Prophylaxis includes immediate pre-exposure prophylaxis (as in the case of emergency personnel responding to an event) and post-exposure prophylaxis (when there is reason to believe a person may have been exposed to anthrax but prior to signs/symptoms of infection). The ability to administer an anti-toxin via IM injection for prophylaxis may provide a valuable alternative to IV infusion in an emergency where medical resources and personnel may be limited or when IV administration is not available or feasible.
The efficacy of Anthim has been studied in two animal models of inhalation anthrax where improved survival rates were demonstrated when Anthim was administered both in combination with antibiotics and as monotherapy. Anthim safety has been evaluated in 320 healthy adult volunteers treated with the proposed therapeutic dose. The most frequently reported adverse reactions (greater than or equal to 1.5%) were headache, pruritus (itching), cough and urticaria (hives).
The costs of production and delivery of Anthim under this delivery order will be fully financed with federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), within the Department of Health and Human Services (HHS) under Contract No. HHSO100201300010I.
Elusys Therapeutics, a private company based in Pine Brook, NJ, is focused on the development of antibody therapeutics for the treatment of infectious disease. Elusys has been engaged in the development of Anthim® (obiltoxaximab), an anthrax biowarfare countermeasure, since 2002. The company has received multiple grants and contracts totaling over $220 million to support the development of Anthim to protect people in the event of an anthrax attack. Today, Anthim has advanced to the final stages of development, and received its first procurement contract for acquisition into the Strategic National Stockpile. For more information, please visit www.elusys.com
Elusys Therapeutics, Inc.
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