PARSIPPANY, NJ, AUGUST 12, 2020 – Elusys Therapeutics, Inc. (Elusys) today announced that Health Canada has approved the company’s New Drug Submission (NDS) for Anthim (obiltoxaximab for injection), the company’s monoclonal antibody (mAb) anthrax antitoxin for the treatment of inhalation anthrax. Anthim is indicated in adult and pediatric patients for the treatment of inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs; and for post-exposure prophylaxis of inhalational anthrax due to B. anthracis when alternative therapies are not available or not appropriate.
Anthim was approved under the Extraordinary Use New Drug (EUND) Regulations, leveraging data from previous studies funded by U.S. government agencies, including the Biomedical Advanced Research and Development Authority (BARDA), the National Institutes of Health (NIH), and the U.S. Department of Defense (DoD). The EUND regulations provide a regulatory pathway for products for which collecting clinical information for its intended use in humans is logistically or ethically not possible. Anthim is designated by Health Canada as an innovative drug, giving it eight years of market exclusivity.
“Elusys is pleased to receive Health Canada approval for Anthim, enabling future procurement of this critical medical countermeasure,” said Elizabeth Posillico, PhD, President and Chief Executive Officer of Elusys. “This is an important step in our efforts to expand availability of Anthim to nations around the world where the U.S. has bilateral relations.”
A Marketing Authorization Application (MAA) was filed in 2019 in the European Union under the Centralized Procedure. The application is currently under review. In March 2016, Anthim received market clearance by the U.S. Food and Drug Administration (FDA).
“In order to protect public health and enhance national health security, it is critical to maintain a robust supply of treatment options, including antitoxins and other medical countermeasures for rapid deployment and treatment of civilian and military populations,” added Timothy S. Leach, MD, MPH, InterimMD Inc.
Anthim (obiltoxaximab) is also licensed by the U.S. Food and Drug Administration (FDA) for adult and pediatric patients for the treatment of inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. Full prescribing information for the U.S. and Canada is available on the Elusys website. Anthim is produced in a single dose liquid formulation for intravenous (IV) infusion.
The company continues to develop a lyophilized (freeze-dried) form of Anthim with U.S. government funding to improve its operational flexibility and life cycle management. Lyophilization of Anthim has the potential to extend product shelf-life, and to improve tolerance of Anthim to temperature fluctuations during shipping and in the field.
Elusys Therapeutics, a private company based in Parsippany, NJ, is focused on the development of antibody therapeutics for the treatment of infectious disease. In early 2016, Anthim® (obiltoxaximab), the company’s monoclonal antibody (mAb) anthrax antitoxin, received market clearance by the U.S. Food and Drug Administration (FDA) for the treatment and prevention of inhalational anthrax in combination with appropriate antibiotics. Elusys was awarded two delivery orders from the U.S. government – $45 million in 2015 and $25 million in 2018 – to produce Anthim for the U.S. Strategic National Stockpile (SNS), the U.S. government’s repository of critical medical supplies for biowarfare preparedness. Elusys has received over $240 million in development grants and contracts from BARDA, the National Institutes of Health (NIH), and the U.S. Department of Defense (DoD). For more information, please visit www.elusys.com
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.
Elusys Therapeutics, Inc.
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