U.S. Food And Drug Administration Accepts Biologics License Application For Anthim (Obiltoxaximab)
PINE BROOK, N.J., June 1, 2015 /PRNewswire/ -- Elusys Therapeutics, Inc. (Elusys) today announced the U.S. Food and Drug Administration (FDA) has accepted for filing and review its Biologics License Application (BLA) for Anthim® (obiltoxaximab) for the treatment and prevention of inhalational anthrax, a top bioterror threat which was submitted on March 20, 2015. Anthim is a candidate for future acquisition into the Strategic National Stockpile, the U.S. government's repository of critical medical supplies for biowarfare preparedness. Anthim has been developed under Fast-Track status and Orphan Drug Designation by the FDA.
"FDA acceptance of our BLA submission is an important milestone toward our goal of supplying Anthim for the Strategic National Stockpile to help protect the U.S. public from the potential deadly bioterror threat of anthrax," said Elizabeth Posillico, PhD, President and Chief Executive Officer of Elusys. "Anthim has been developed under two contracts with the Biological Advanced Research and Development Authority (BARDA), and we look forward to continuing to work with BARDA in the interest of our nation's security."
Inhalation anthrax is a life-threatening infectious disease caused by the bacterium Bacillus anthracis and remains one of the nation's top biowarfare threats. 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 50% 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.
The filing acceptance is based on submission of efficacy data studied in animal models of inhalational anthrax and safety data from 350 healthy human volunteers receiving the proposed human therapeutic dose of Anthim administered intravenously. Efficacy and safety data obtained on intramuscular administration of Anthim were also included in the application. The more common treatment emergent adverse events occurring in clinical trials of Anthim administered by IV infusion compared to placebo included headache, pruritus, cough, urticaria and rash.
About Anthim
Anthim is a high-affinity monoclonal antibody in development for the treatment and prevention of inhalational anthrax, a top bioterror threat. Anthim is formulated as a solution and is the only anthrax anti-toxin in advanced stages of development that is being investigated for intravenous (IV) treatment 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 may provide a valuable alternative to IV injection in an emergency where medical resources and personnel may be limited or when IV administration is not feasible.
Anthim® (obiltoxaximab) was granted Fast Track status and Orphan Drug Designation by the FDA.
This program is supported with federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), the Department of Health and Human Services (HHS) under Contract Nos. HHSO100201000026C and HHS0100201100034C.
About Elusys Therapeutics, Inc.
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 $200 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 is closer to achieving the company's goals of receiving FDA licensure and becoming part of the Strategic National Stockpile. For more information, please visit www.elusys.com.
SAFE HARBOR STATEMENT
This announcement includes statements that are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. This release includes forward looking statements. Any statements, other than statements of historical fact, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, and any other statements containing the words "believes", "expects", "anticipates", "plans", "estimates" and similar expressions, are forward-looking statements. Such statements are based upon the current beliefs and expectations of management that are subject to risks, uncertainties and other important factors that could cause the company's actual results to differ materially from those indicated by such forward-looking statements. The guidance in this presentation is only effective as of the date given and will not be updated or affirmed unless and until the Company publicly announces updated or affirmed guidance.
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SOURCE Elusys Therapeutics, Inc.
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