Emergent BioSolutions Inc. this week announced that it is launching a ruggedized, military-grade auto-injector device, known as Emergard, which is designed for intramuscular self-injection of chemical threat agent antidotes and other emergency response medical treatments.
Emergent acquired rights to the device, formerly known as PC-2M, through an exclusive worldwide license agreement with Pharma Consult Ges.m.b.H of Austria, which has been selling the auto-injector in limited quantities to select allied nations. The company has also executed a global manufacturing and supply agreement for Emergard with Nemera Development S.A.
Emergent plans to supply cGMP-compliant product through current global sales channels for its other biodefense products.
Emergard is not approved by the U.S. Food and Drug Administration (FDA) and is not currently marketed in the U.S., although the company intends to pursue FDA approval of the device. The company has received preliminary interest for Emergard from countries outside the U.S. and anticipates making its first deliveries in limited quantities in Q4 2015.
“Emergent is excited to add the Emergard auto-injector platform to our portfolio, which allows us to supply critical medical countermeasures to militaries and countries across the globe,” stated Adam Havey, executive vice president and president, biodefense division of Emergent BioSolutions.
According to Havey, Emergent estimates the global market for military-grade auto-injectors to be between $100-$200 million, with one major pharmaceutical company and multiple regional players in the market space.
Emergard is designed to be transported, stored, and operated in a military environment and to ensure needle penetration and successful injection through chemical protective gear.
Source: Emergent Biosolutions press release, adapted. Emergard is a trademark protected term by Emergent Biosolutions.