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PINE BROOK, N.J., Aug. 4 /PRNewswire/ --
Elusys Therapeutics, Inc. (Elusys), a privately-held biopharmaceutical company, announced today that it has been awarded a second contract year of funding valued at $40.6 million for the advanced development of Anthim for the prevention and treatment of anthrax infection following a biowarfare attack. This funding is in addition to $16.8 million already received under this contract and is part of a potential five year contract award totaling up to $143 million if all options are exercised by the Government. Funding will be provided 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. Anthrax is a life-threatening infectious disease caused by the bacteria Bacillus anthracis and remains one of the nation's top biowarfare threats. Inhaled anthrax is often fatal even if treated with antibiotics. Anthim is an anti-toxin that significantly increases survival in anthrax-infected animals and is a promising candidate for the treatment of anthrax infection in people.
If all activities in the development program are completed to the U.S. Food and Drug Administration's (FDA) satisfaction, the federal government could purchase Anthim for the Strategic National Stockpile 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.
"We are delighted by our continued progress with Anthim's development and BARDA's ongoing commitment to further support our efforts," said Elizabeth Posillico, PhD, President and Chief Executive Officer of Elusys. "Anthim consistently provides significant survival benefit in the treatment of anthrax infection in animal models and is well-tolerated when administered to human subjects. Anthim has the potential to deliver considerable therapeutic benefit to Americans infected with anthrax in a bioterrorism emergency."
The second year of the contract, one of the largest contracts awarded by BARDA for advanced product development, will support the company's efforts to gain FDA licensure, including manufacturing activities, human safety trials, and non-clinical effectiveness studies in animals. Elusys has completed two safety studies in humans with Anthim and numerous studies demonstrating safety and efficacy in animal models. Anthim has been granted Fast-Track status and Orphan Drug Designation by the FDA.
Elusys has also recently received funding to support further development of an intramuscular (IM) formulation of Anthim from the Department of Defense. IM administration will allow rapid administration of anti-toxin treatment to large numbers of people in an emergency setting.
About Anthim
Anthim 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. It is being developed for prevention and treatment of inhalational anthrax following a biowarfare attack.
Anthim has been extensively tested for efficacy and safety in animals and safety in human volunteers. It shows excellent potential as an effective, life-saving, therapeutic for the treatment of people infected by or exposed to anthrax spores. A single dose of Anthim consistently protects 70% to 100% of anthrax-infected animals from death.
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), under Contract No. HHSO100201000026C, the National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Health (NIH), the Department of Health and Human Services (HHS), under Contract No. HHSN272200700035C, and the Department of Defense, under Contract No. W9l l3M-10-C-0024.
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 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 contracts totally up to $177 million in government funding. Anthim, 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.
SOURCE Elusys Therapeutics, Inc.
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If all activities in the development program are completed to the U.S. Food and Drug Administration's (FDA) satisfaction, the federal government could purchase Anthim for the Strategic National Stockpile 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.
"We are delighted by our continued progress with Anthim's development and BARDA's ongoing commitment to further support our efforts," said Elizabeth Posillico, PhD, President and Chief Executive Officer of Elusys. "Anthim consistently provides significant survival benefit in the treatment of anthrax infection in animal models and is well-tolerated when administered to human subjects. Anthim has the potential to deliver considerable therapeutic benefit to Americans infected with anthrax in a bioterrorism emergency."
The second year of the contract, one of the largest contracts awarded by BARDA for advanced product development, will support the company's efforts to gain FDA licensure, including manufacturing activities, human safety trials, and non-clinical effectiveness studies in animals. Elusys has completed two safety studies in humans with Anthim and numerous studies demonstrating safety and efficacy in animal models. Anthim has been granted Fast-Track status and Orphan Drug Designation by the FDA.
Elusys has also recently received funding to support further development of an intramuscular (IM) formulation of Anthim from the Department of Defense. IM administration will allow rapid administration of anti-toxin treatment to large numbers of people in an emergency setting.
About Anthim
Anthim 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. It is being developed for prevention and treatment of inhalational anthrax following a biowarfare attack.
Anthim has been extensively tested for efficacy and safety in animals and safety in human volunteers. It shows excellent potential as an effective, life-saving, therapeutic for the treatment of people infected by or exposed to anthrax spores. A single dose of Anthim consistently protects 70% to 100% of anthrax-infected animals from death.
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), under Contract No. HHSO100201000026C, the National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Health (NIH), the Department of Health and Human Services (HHS), under Contract No. HHSN272200700035C, and the Department of Defense, under Contract No. W9l l3M-10-C-0024.
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 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 contracts totally up to $177 million in government funding. Anthim, 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.
SOURCE Elusys Therapeutics, Inc.
