Emergent launches in-licensed military-grade autoinjector outside the U.S., aims for FDA approval

Emergard, formerly PC-2M--Courtesy of Pharma Consult

Emergent BioSolutions ($EBS) has launched a military-grade intramuscular auto-injector device for self-administered antidotes or other chemical threat treatments. For now, the rollout is only ex-U.S., but the infectious disease specialist said it will seek FDA approval for the device, dubbed Emergard.

It expects to make the first deliveries of the device during the fourth quarter. Emergent gained the rights to Emergard, previously called PC-2M, under an exclusive worldwide license with the Austrian company Pharma Consult. Emergent has made a supply deal for production of Emergard with French drug delivery device specialist Nemera Development.

Adam Havey

"Emergent is excited to add the Emergard autoinjector platform to our portfolio, which allows us to supply critical medical countermeasures to militaries and countries across the globe," said Adam Havey, Emergent EVP and president of the Biodefense Division, in a statement.

The company expects that there's a $100 million to $200 million annual global market for military-grade autoinjectors, although it noted that competitors include a major pharma company and several regional players.

Emergard is a prefilled autoinjector pen that is designed to penetrate even through chemical protective gear to provide an intramuscular injection of an antidote or another military-grade treatment.

Emergent, which has a $1.2 billion market cap, markets several FDA-approved biodefense products including anthrax vaccine BioThrax, intravenous immune globulin vaccine Vigiv, botulism antitoxin Bat and anthrax vaccine Anthrasil.

As for Emergard, Havey added, "We intend to build upon our broad capabilities in government contracting and commercial distribution of medical countermeasures and seize this global market opportunity to drive revenue growth."

- here is the release

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