09.18.17
Emergent BioSolutions has been awarded a contract valued at approximately $63 million by the Biomedical Advanced Research and Development Authority (BARDA) to develop an antidote spray device for the treatment of known or suspected acute cyanide poisoning. The single-use intranasal spray device will deliver a stabilized form of isoamyl nitrite (SIAN) and is intended for use by first responders and medical personnel following a cyanide incident.
“Emergent has a successful history of developing medical countermeasures that address the U.S. government’s top priority public health threats,” said Sean Kirk, senior vice president, manufacturing operations and interim head, devices business unit, Emergent BioSolutions. “We are committed to fulfilling BARDA’s requirements for an easily-administered treatment for acute cyanide poisoning, in collaboration with Southwest Research Institute. The development of the intranasal SIAN device will expand the company’s portfolio of novel devices to combat chemical threats. We are excited about the potential of this product candidate to meet the needs of both the government and commercial markets.”
Under the five-year contract, Emergent will work together with Southwest Research Institute, an independent, nonprofit applied R&D organization headquartered in San Antonio, TX, to advance the development of SIAN towards licensure, including completing regulatory activities required to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to enable first-in-human studies, conducting initial clinical studies, and advancing non-clinical and Chemistry, Manufacturing, and Controls development activities.
This contract HHSO100201700001C is funded by BARDA, a division of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services.
“Emergent has a successful history of developing medical countermeasures that address the U.S. government’s top priority public health threats,” said Sean Kirk, senior vice president, manufacturing operations and interim head, devices business unit, Emergent BioSolutions. “We are committed to fulfilling BARDA’s requirements for an easily-administered treatment for acute cyanide poisoning, in collaboration with Southwest Research Institute. The development of the intranasal SIAN device will expand the company’s portfolio of novel devices to combat chemical threats. We are excited about the potential of this product candidate to meet the needs of both the government and commercial markets.”
Under the five-year contract, Emergent will work together with Southwest Research Institute, an independent, nonprofit applied R&D organization headquartered in San Antonio, TX, to advance the development of SIAN towards licensure, including completing regulatory activities required to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to enable first-in-human studies, conducting initial clinical studies, and advancing non-clinical and Chemistry, Manufacturing, and Controls development activities.
This contract HHSO100201700001C is funded by BARDA, a division of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services.