Elusys Therapeutics Finalizes HHS Contract to Deliver ANTHIM®, Its Treatment for Inhalation Anthrax, to the U.S. Department of Health and Human Services
January 31 2022 - 7:30AM
Elusys Therapeutics, Inc. (Elusys) announced today that it has
finalized a contract with the Office of the Assistant Secretary for
Preparedness and Response (ASPR) in the U.S. Department of Health
and Human Services (HHS) for the continued supply of ANTHIM
(obiltoxaximab), an anthrax antitoxin, for use against a potential
anthrax attack.
“Elusys is pleased to continue its successful track record of
supplying a critical medicine to treat the deadly effects of
anthrax exposure,” said Elizabeth Posillico, president and chief
executive officer of Elusys. “ANTHIM is a key therapeutic in the
U.S. government’s preparedness strategy to protect the U.S.
population against natural and man-made biothreats.”
The contract for the procurement of ANTHIM consists of a base
period of performance, valued at $50 million, which has been
fulfilled. The contract includes options valued up to $31 million.
If all options are exercised, the total contract value will be
$80,864,000 with completion of the contract expected by the first
half of 2023. Contract 75A50121C00073 is funded by HHS ASPR.
As previously announced, Elusys has executed a definitive merger
agreement with Heat Biologics, Inc. (NASDAQ: HTBX), pursuant to
which Elusys will merge into a wholly owned subsidiary of Heat. The
acquisition is expected to close during the first quarter of 2022
and is subject to customary closing conditions.
About ANTHIMANTHIM 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.
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.
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
ANAPHYLAXISHypersensitivity 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 PRECAUTIONSHypersensitivity 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 POPULATIONSPediatric 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 Elusys, based in
Parsippany, NJ, is focused on the development of antibody
therapeutics for the treatment of infectious disease.
ANTHIM®(obiltoxaximab) Injection, 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 New Drug Submission (NDS) 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.
CONTACT: Elizabeth PosillicoElusys
Therapeutics, Inc.t: 973.808.0222e: eposillico@elusys.com
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