May 24, 2016 10:50 PM ET

Biotechnology

Company Overview of Elusys Therapeutics, Inc.

Company Overview

Elusys Therapeutics, Inc. is a biopharmaceutical company that focuses on the development of antibody therapeutics for the treatment of a life-threatening infectious disease. The company offers Anthim, an anti-toxin antibody for the treatment and prophylaxis of inhalational anthrax disease following a biowarfare attack. Its Anthim targets the protective antigen of B. anthracis and neutralizes the lethal effects of anthrax toxins by binding to protective antigen. Elusys Therapeutics, Inc. was formerly known as ErythroMed, Inc. The company was founded 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
Senior Director of Human Resources & Administration
Vice President of Corporate Development
Age: 53
Vice President of Development and Manufacturing
Vice President of Regulatory Affairs
Compensation as of Fiscal Year 2015.

Elusys Therapeutics, Inc. Key Developments

Elusys Therapeutics, Inc. Receives FDA Approval for ANTHIMĀ® (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.

U.S. Food And Drug Administration Accepts Biologics License Application for Anthim of Elusys Therapeutics, Inc

Elusys Therapeutics, Inc. announced the U.S. Food and Drug Administration (FDA) has accepted for filing and review its Biologics License Application (BLA) for Anthim (obiltoxaximab) for the treatment and prevention of inhalational anthrax, a top bioterror threat which was submitted on March 20, 2015. Anthim is a candidate for future acquisition into the Strategic National Stockpile, the U.S. government's repository of critical medical supplies for biowarfare preparedness. Anthim has been developed under Fast-Track status and Orphan Drug Designation by the FDA. Inhalation anthrax is a life-threatening infectious disease caused by the bacterium Bacillus anthracis and remains one of the nation's top biowarfare threats. Much of the morbidity and mortality of anthrax can be attributed to anthrax toxins. Inhaled anthrax is often fatal, despite treatment with antibiotics. In the 2001 anthrax letter attacks, inhalational anthrax had a fatality rate of approximately 50% in humans infected, even when victims were given antibiotics and supportive hospital care. Under current guidelines, CDC recommends the use of anthrax antitoxins with antibiotics in cases where there is a high level of clinical suspicion for systemic anthrax. The filing acceptance is based on submission of efficacy data studied in animal models of inhalational anthrax and safety data from 350 healthy human volunteers receiving the proposed human therapeutic dose of Anthim administered intravenously. Anthim is a high-affinity monoclonal antibody in development for the treatment and prevention of inhalational anthrax, a top bioterror threat. Anthim is formulated as a solution and is the only anthrax anti-toxin in advanced stages of development that is being investigated for intravenous (IV) treatment and intramuscular (IM) prophylaxis administration. IV administration is being evaluated for the treatment of patients who have established infection and are symptomatic for anthrax disease, as well as for prophylaxis. Prophylaxis includes immediate pre-exposure prophylaxis (as in the case of emergency personnel responding to an event) and post-exposure prophylaxis (when there is reason to believe a person may have been exposed to anthrax but prior to signs/symptoms of infection).

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