Emergent BioSolutions said today it won an approximately $63 million contract from the Biomedical Advanced Research and Development Authority (BARDA) toward developing an antidote spray device for treating known or suspected acute cyanide poisoning.
The single-use intranasal spray device will be intended for use by first responders and medical personnel to deliver a stabilized form of isoamyl nitrite (SIAN) following a cyanide incident.
“The development of the intranasal SIAN device will expand the company’s portfolio of novel devices to combat chemical threats,” Sean Kirk, Emergent svp, manufacturing operations, and interim head of the company’s devices business unit, said in a statement. “We are excited about the potential of this product candidate to meet the needs of both the government and commercial markets.”
Under its five-year contract with BARDA, Emergent will collaborate to develop the device with Southwest Research Institute (SwRI), an independent, nonprofit applied R&D organization headquartered in San Antonio, TX.
SwRI won a $4.4 million BARDA contract in 2011 to develop a drug formulation and delivery system to treat cyanide exposure. During that contract, according to the Institute, nasal delivery of isoamyl nitrite was shown to be surprisingly effective at treating and rapidly reversing otherwise lethal cyanide exposure during nonclinical testing.
As a result, BARDA in 2014 approved a 28-month follow-on contract of $8.3 million toward development of a nasal-delivery, first-line treatment system to combat cyanide poisoning, using an intranasal formulation of isoamyl nitrite. The follow-on agreement included development of additional clinical supplies, regulatory filings, and testing in two animal models to show safety and efficacy to support FDA approval.
Emergent said the partners will advance the development of SIAN toward licensure, including completing regulatory activities required to submit an Investigational New Drug (IND) application to the FDA to enable first-in-human studies, conducting initial clinical studies, and advancing nonclinical and chemistry, manufacturing, and controls development activities.
Advanced Development Priority
Development of a cyanide antidote was among advanced development priorities through the 2020 federal fiscal year that were identified by the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) in its 2016 Strategy and Implementation Plan.
Cyanide is among high-priority threats for which the Plan identified medical countermeasures as being deemed necessary by PHEMCE, an interagency coordinating body. PHEMCE is led by the U.S. Department of Health and Human Services (HHS) Assistant Secretary for Preparedness and Response, comprising the Centers for Disease Control and Prevention, the NIH, the FDA, and interagency partners at the Departments of Veterans Affairs, Defense, Homeland Security, and Agriculture.
Emergent has been awarded Contract No. HHSO100201700001C by BARDA, a division of the Office of the Assistant Secretary for Preparedness and Response within HHS.
Headquartered in Gaithersburg, MD, Emergent has committed to addressing public health threats with products that will protect and enhance 50 million lives by 2025.
The cyanide antidote device contract is the third multimillion-dollar award the company has won from BARDA this year.
In March, Emergent won a two-year $100 million contract to supply its BioThrax® (anthrax vaccine adsorbed) vaccine for the U.S. Strategic National Stockpile. A month earlier, Emergent reported receiving from BARDA an up-to-$30.5 million task order to develop monoclonal antibody therapeutics against viral hemorrhagic fever.
