Oct 06 2015
PINE BROOK, New Jersey—Elusys Therapeutics, Inc. (Elusys) today announced it has been awarded $16 million of additional funding from the U.S. Government to further advance development of a lyophilized form of Anthim® (obiltoxaximab), an investigational agent for the treatment of inhalational anthrax infection following a biowarfare attack. The company has now received total authorized funding of $195 million under two advanced development contracts for Anthim from the Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.
Lyophilization (freeze drying) of the current liquid formulation of Anthim has the potential to extend product shelf-life once in the Strategic National Stockpile (SNS), the U.S. Government’s repository of critical medical supplies for biowarfare and public health emergency preparedness. Lyophilization also has the potential to improve tolerance of Anthim to extreme temperatures during shipping and field use. These improvements could enhance operational flexibility and improve life cycle management.
The funds will be used to continue Elusys’ lyophilization development program and validation of the commercial production process. In addition to BARDA, Elusys has received prior funding from the U.S. Department of Defense and the National Institutes of Health to support the development of its liquid form of Anthim.
“We are pleased to have the ongoing support of the U.S. Government, to further improve the potential usefulness of Anthim to protect the American public, military personnel and first responders in an emergency,” said Elizabeth Posillico, PhD, President and Chief Executive Officer of Elusys. “A lyophilized form of Anthim has the potential for longer shelf life and improved temperature stability in the field, as well as greater efficiencies in managing anthrax antitoxins in the SNS.”
The U.S. Food and Drug Administration (FDA) is currently reviewing Elusys’ Biologics License Application (BLA) for the liquid form of Anthim for treatment of inhalational anthrax in combination with appropriate antibiotics and prophylaxis when alternative therapies are not available or are not appropriate. Anthim is a candidate for future acquisition into the SNS. 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 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.
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 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). 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 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.
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 $230 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.
Elusys Therapeutics, Inc.
e: [email protected]
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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