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Press Release

Elusys Receives Second Delivery Order From U.S. Government for ANTHIM®, its Treatment for Inhalation Anthrax

Elusys Therapeutics,Inc.
Posted on: 23 Apr 18
Elusys Receives Second Delivery Order From U.S. Government for ANTHIM®, its Treatment for Inhalation Anthrax Elusys receives $19.7 million for delivery of ANTHIM under first Delivery Order

PR Newswire

PINE BROOK, N.J., April 23, 2018

PINE BROOK, N.J., April 23, 2018 /PRNewswire/ -- Elusys Therapeutics, Inc. (Elusys) announced today that it has been awarded a $25.2 million follow-on Delivery Order (DO) by the U.S. Government for ANTHIM (obiltoxaximab).  This is the second DO issued for ANTHIM by the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response (HHS/ASPR).  This procurement will increase the inventory of ANTHIM stored in the Strategic National Stockpile (SNS) for use as a medical countermeasure against a potential bioterrorist attack.

ANTHIM received U.S. Food and Drug Administration (FDA) marketing approval in March 2016. 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 prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. ANTHIM should only be used for prophylaxis when its benefit for prevention of inhalational anthrax outweighs the risk of hypersensitivity and anaphylaxis. The effectiveness of ANTHIM is based solely on efficacy studies in animal models of inhalational anthrax. There have been no studies of the safety or pharmacokinetics (PK) of ANTHIM in the pediatric population. Dosing in pediatric patients was derived using a population PK approach. ANTHIM does not have direct antibacterial activity. ANTHIM should be used in combination with appropriate antibacterial drugs. ANTHIM is not expected to cross the blood-brain barrier and does not prevent or treat meningitis.

"Obtaining a second order for ANTHIM is significant in that it signals the commitment of BARDA to build up reserves of ANTHIM in the Strategic National Stockpile so that it is available for the treatment of U.S. citizens, first responders and military personnel in an anthrax emergency," said Elizabeth Posillico, PhD, President and Chief Executive Officer of Elusys. "We are pleased that the U.S. Government has invested over $70 million in the procurement of ANTHIM, extending a successful and ongoing collaboration that began at the early stages of ANTHIM development."

Elusys also announced today that it recently received $19.7 million under the first DO issued by BARDA in 2015 with total contract value of $44.9 million, as additional contractual obligations for the provision of ANTHIM have been satisfied.

Since 2002, Elusys has received over $240 million in grants and contracts from BARDA, the U.S. Department of Defense (DoD), and the National Institutes of Health (NIH) for the development of ANTHIM. BARDA is partnering with the U.S. Centers for Disease Control and Prevention (CDC), in the management of the SNS, to ensure that this lifesaving countermeasure can be provided in the event of an anthrax outbreak.

ABOUT ANTHIM 
ANTHIM received U.S. Food and Drug Administration (FDA) marketing approval in March 2016. 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 prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. ANTHIM should only be used for prophylaxis when its benefit for prevention of inhalational anthrax outweighs the risk of hypersensitivity and anaphylaxis. The effectiveness of ANTHIM is based solely on efficacy studies in animal models of inhalational anthrax. There have been no studies of the safety or pharmacokinetics (PK) of ANTHIM in the pediatric population. Dosing in pediatric patients was derived using a population PK approach. ANTHIM does not have direct antibacterial activity. ANTHIM should be used in combination with appropriate antibacterial drugs. ANTHIM is not expected to cross the blood-brain barrier and does not prevent or treat meningitis.

ANTHIM is a monoclonal antibody that binds to the protective antigen (PA) component of anthrax toxin. ANTHIM's toxin neutralizing activity prevents entry of anthrax toxin into susceptible cells, avoiding further spread of the toxin throughout the body and the ensuing tissue damage that leads to death. ANTHIM is supplied as single-dose vials for IV infusion.

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.

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, a private company based in Pine Brook, NJ, is focused on the development of antibody therapeutics for the treatment of infectious disease. In March 2016, the U.S. Food and Drug Administration (FDA) approved ANTHIM (obiltoxaximab) Injection (www.anthim.com), the company's monoclonal antibody (mAb) anthrax antitoxin, 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. Elusys has received over $240 million in development grants and contracts from the Biomedical Advanced Research and Development Authority (BARDA), the U.S. Department of Defense (DoD), and the National Institutes of Health (NIH). Current investors include EW Healthcare Partners, Invesco Private Capital, Crescendo Ventures, MedImmune Ventures and Pfizer. For more information, visit www.elusys.com.

The ANTHIM program was supported with federal funds from the Office of the Assistant Secretary for Preparedness and Response (ASPR), Biomedical Advanced Research and Development Authority (BARDA), within the Department of Health and Human Services (HHS) under Contracts Numbers HHSO100201000026C, funded at $140.9 million, and HHS0100201100034C, funded at $62.5 million. The first delivery order for ANTHIM valued at $ 44.9 million and the second delivery order valued at $ 25.2 million were issued by the Office of the Assistant Secretary for Preparedness and Response (ASPR), Biomedical Advanced Research and Development Authority (BARDA), within the Department of Health and Human Services (HHS) under Contract No. HHSO100201300010I.

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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SOURCE Elusys Therapeutics, Inc.

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Last updated on: 23/04/2018

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