September 26, 2016 8:13 PM ET

Biotechnology

Company Overview of Elusys Therapeutics, Inc.

Company Overview

Elusys Therapeutics, Inc. engages in the development of antibody therapeutics for the treatment of infectious diseases. It provides ANTHIM (obiltoxaximab) Injection, a monoclonal antibody anthrax antitoxin for the treatment of inhalational anthrax due to Bacillus anthracis in combination with antibacterial drugs, and for prophylaxis of inhalational anthrax. The company was incorporated in 1998 and is based in Pine Brook, New Jersey.

25 Riverside Drive

Unit One

Pine Brook, NJ 07058

United States

Founded in 1998

Phone:

973-808-0222

Fax:

973-808-0322

Key Executives for Elusys Therapeutics, Inc.

Chief Executive Officer, President and Director
Vice President of Finance
Senior Director of Human Resources & Administration
Vice President of Corporate Development
Age: 54
Vice President of Development and Manufacturing
Compensation as of Fiscal Year 2016.

Elusys Therapeutics, Inc. Key Developments

Elusys Therapeutics Announces Publication Of Results From Five Clinical Trials With Its Inhalational Anthrax Antitoxin, ANTHIM® (obiltoxaximab) Injection

Elusys Therapeutics, Inc. announced that the company published data on over 450 healthy adult subjects from five clinical trials used to support recent U.S. Food and Drug Administration (FDA) marketing approval of ANTHIM® (obiltoxaximab) Injection, its treatment for inhalation anthrax. The results are published online at Clinical Therapeutics. ANTHIM received 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 was developed under the FDA's Animal Rule which requires human healthy volunteer safety and pharmacokinetic studies in addition to animal efficacy studies. The Animal Rule applies to approval of drugs and biologics intended to treat serious or life-threatening conditions caused by exposure to lethal or permanently disabling substances and for which clinical efficacy studies in humans are unethical or unfeasible.

Elusys Therapeutics, Inc. Receives FDA Approval for ANTHIM® (obiltoxaximab) Injection for the Treatment and Prophylaxis of Inhalational Anthrax

Elusys Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved ANTHIM (obiltoxaximab) Injection, the company's monoclonal antibody (mAb) anthrax antitoxin. 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 intravenous (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.

Elusys Therapeutics, Inc. Receives First Delivery Order from U.S. Government for Anthim

Elusys Therapeutics, Inc. announced it has been awarded its first delivery order under a procurement contract for Anthim (obiltoxaximab), an investigational agent for the treatment of inhalational anthrax infection, valued at $44.9 million. The delivery order was issued 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), for acquisition of Anthim into the Strategic National Stockpile (SNS) as a countermeasure against a potential bioterrorist attack.

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