Elusys Executes Initial Procurement Contract to Deliver ANTHIM® to the Canadian Government

New contract marks the first international sale of ANTHIM®

PARSIPPANY, N.J., April 27, 2022 – Today Elusys Therapeutics annoucned it has finalized a contract with the Canadian government to deliver ANTHIM® (obiltoxaximab for injection), a treatment for inhalation anthrax, for use against a potential anthrax attack.

ANTHIM® will be delivered to Canada’s National Emergency Strategic Stockpile under a procurement contract totaling CAD $7.9 million (i). The goal of this program is to establish a Canadian supply of Anthim for use as a medical countermeasure against natural and man-made anthrax biothreats.

Jeff Wolf, CEO of Elusys Therapeutics, commented, “We are excited to announce this first international contract to supply ANTHIM® to Canada, which is particularly timely given the growing global geopolitical uncertainty and emerging threats. This agreement complements our broader biodefense initiatives. We are focused on expanding sales of ANTHIM®, abroad and this first international contract is an important validation of our strategy.”

According to the United States Centers for Disease Control and Prevention (CDC), if a bioterrorist attack were to happen, bacillus anthracis, the bacteria that causes anthrax, would be one of the biological agents most likely to be used, since these spores are easily found in nature, can be produced in a lab, and may remain in the environment for a prolonged period. In recent Congressional testimony, Gerald Parker, Associate Dean of Texas A&M’s College of Veterinary Medicine & Biomedical Sciences, indicated that the top three bioterrorist threats were “anthrax, anthrax, and anthrax.”
Elusys has previously established a successful track record collaborating with U.S. government agencies including the Biomedical Advanced Research and Development Authority (BARDA), the National Institutes of Health (NIH), the Strategic National Stockpile (SNS) and the Department of Defense (DOD). To date, Elusys has been awarded over $400 million in research and development grants, contracts and procurement orders from BARDA and SNS through ongoing, multi-year partnerships with the U.S. government.
About ANTHIM®

Anthrax is a life-threatening infectious disease caused by Bacillus anthracis. Cases of inhalational anthrax in humans can occur through intentional spread of B. anthracis spores as a biowarfare or bioterrorism agent. B. anthracis spores introduced through the lungs lead to inhalational anthrax, which is deadly in humans.

ANTHIM® (obiltoxaximab for injection) is indicated in adult and pediatric patients for the treatment of inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs. ANTHIM® is indicated for post-exposure prophylaxis of inhalational anthrax due to B. anthracis when alternative therapies are not available or not appropriate. The effectiveness of ANTHIM® is based solely on efficacy studies in animal models of inhalational anthrax.

IMPORTANT SAFETY INFORMATION Including BOXED WARNING
WARNING: HYPERSENSITIVITY and ANAPHYLAXIS
Hypersensitivity reactions, including anaphylaxis, have been reported during ANTHIM infusion. ANTHIM should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis. Stop ANTHIM infusion immediately and treat appropriately if hypersensitivity or anaphylaxis occurs.
WARNINGS AND PRECAUTIONS
Hypersensitivity and anaphylaxis have been reported during the IV infusion of ANTHIM. Due to the risk of hypersensitivity and anaphylaxis, ANTHIM should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis. Monitor individuals who receive ANTHIM closely for signs and symptoms of hypersensitivity reactions throughout the infusion and for a period of time after administration. Stop ANTHIM infusion immediately and treat appropriately if hypersensitivity or anaphylaxis occurs. Pre-medication with diphenhydramine is recommended prior to administration of ANTHIM. Diphenhydramine pre-medication does not prevent anaphylaxis and may mask or delay onset of symptoms of hypersensitivity.
ADVERSE REACTIONS
The safety of ANTHIM has been studied only in healthy volunteers. It has not been studied in patients with inhalational anthrax. The most frequently reported adverse reactions were headache, pruritus, infections of the upper respiratory tract, cough, vessel puncture site bruise, infusion site swelling, urticaria, nasal congestion, infusion site pain, and pain in extremity.
USE IN SPECIFIC POPULATIONS
Pediatric Use: There have been no studies of the safety or PK of ANTHIM in the pediatric population.

To see the complete prescribing information for ANTHIM, click here

About Elusys Therapeutics, Inc.
Elusys Therapeutics is focused on the development of antibody therapeutics for the treatment of infectious disease. ANTHIM®(obiltoxaximab), the company’s monoclonal antibody (mAb) anthrax antitoxin, received market clearance by the U.S. Food and Drug Administration (FDA) in March 2016. In July 2020, Health Canada approved ANTHIM’s Extraordinary Use New Drug Submission for the treatment of inhalation anthrax. ANTHIM has also received marketing approved in the E.U. and the U.K., under the trade name of Obiltoxaximab SFL. For more information, please visit www.elusys.com.