Pine Brook, NJ – August 1, 2012 – Elusys Therapeutics, Inc. (Elusys), a biopharmaceutical company developing countermeasures for biodefense, announced today that it has been awarded additional funding from the U.S. Government, valued at $50.2 million, for the advanced development of ETI-204 (Anthim), an investigational agent for the treatment of anthrax infection following a biowarfare attack. 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. Anthrax remains one of the nation’s top biowarfare threats. Inhaled anthrax is often fatal, despite treatment with antibiotics. ETI-204 is an investigational anti-toxin and is a promising candidate for the treatment of inhalational anthrax in humans.
The $50.2 million awarded by 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, will be used to conduct definitive efficacy studies in animals and complete validation of the commercial manufacturing process for ETI-204. This third year of funding is in addition to $57.5 million the company already received under this contract and is part of a five year award totaling up to $143 million. This advanced product development contract is supporting Elusys’ efforts to gain U.S. Food and Drug Administration (FDA) licensure, including manufacturing activities, human safety trials and non-clinical effectiveness studies in animals.
“We are pleased that the U.S. Government is continuing to support our efforts to advance ETI-204 through the final stages of our development program, including validation of our commercial manufacturing processes,” said Elizabeth Posillico, PhD, President and Chief Executive Officer of Elusys. “We recently completed a clinical dose-escalation study and look forward to reviewing those data.” The company’s dose-escalation study, including a total of 108 human subjects, collected additional safety and pharmacokinetic (PK) data at doses up to 16 mg/kg, administered intravenously. Elusys has completed two other dose escalation safety studies in humans and a number of studies assessing activity of ETI-204 against anthrax in two animal species.
If all activities in the ETI-204 development program are completed to FDA’s satisfaction, the federal government could purchase ETI-204 for the Strategic National Stockpile (SNS) under Project BioShield. Project BioShield was established in 2004 to provide much needed funding to procure important countermeasures to protect the American public in the event of a biowarfare attack. ETI-204 was granted Fast-Track status and Orphan Drug Designation in 2006 by the FDA.
ETI-204 is a high-affinity, humanized and deimmunized monoclonal antibody that targets the protective antigen of B. anthracis and neutralizes the lethal effects of anthrax toxins by binding to Protective Antigen. It is an investigational agent being developed for treatment of inhalational anthrax following a biowarfare attack.
ETI-204 efficacy and safety is being studied in animals and safety studies are being conducted with human volunteers. To date, five studies assessing the efficacy and safety of ETI-204 in animals with inhalational anthrax have been completed. As previously mentioned, three studies assessing pharmacokinetics and safety of intravenous (IV) administration of ETI-204 in humans have been conducted. In the two completed studies the adverse event profile of ETI-204 was comparable to placebo and the more common adverse events related to ETI-204 administration were headache and upper respiratory tract infection. ETI-204 is formulated as a solution suitable for either IV or intramuscular (IM) administration. This project 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.
Elusys Therapeutics, a private company based in Pine Brook, NJ, is focused on the development of antibody therapeutics for the treatment of life-threatening disease. Elusys has been engaged in development of biodefense countermeasures since 2000. The company has established experience in government contract management and to date has received multiple grants and has the potential to receive, in total, up to $246 million in government funding. ETI-204, a highly effective, anthrax anti-toxin, is in late-stage development and is a strong candidate for future procurement into the Strategic National Stockpile. For more information, please visit www.elusys.com.
Elizabeth G. Posillico, PhD
President & CEO
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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