CROSSJECT, a French specialty pharmaceutical company, has received an additional $11.3 million in funding from the U.S. Biomedical Advanced Research and Development Authority (BARDA) to advance development of its needle-free epilepsy treatment ZEPIZURE. The new funding brings total BARDA contract support for the ZENEO Midazolam auto-injector to $43.3 million.
The additional funds will support regulatory and manufacturing activities as CROSSJECT progresses toward FDA Emergency Use Authorization (EUA) and New Drug Application (NDA) submissions. The company has achieved notable recent milestones including completion of validation batches and a facility audit, marking significant progress in meeting regulatory requirements.
Strategic National Stockpile Partnership
Upon FDA approval, BARDA has committed to purchasing 306,000 adult ZENEO Midazolam and 54,000 pediatric ZENEO Midazolam autoinjectors for a total of $60.8 million. This acquisition will support the CHEMPACK program and U.S. Strategic National Stockpile initiative, providing emergency epilepsy treatment capabilities for national preparedness.
"We are grateful for BARDA's continued partnership and investment which underlines the importance of ZEPIZURE to the CHEMPACK program and the U.S. Strategic National Stockpile initiative," said Patrick Alexandre, CEO of CROSSJECT. "We are approaching key regulatory and commercial production milestones with confidence, supported by the diligence of our internal teams, manufacturing partners and the strength of our collaborations with BARDA."
Needle-Free Emergency Treatment Platform
The ZENEO platform represents a significant advancement in emergency drug delivery, designed to enable patients or untrained caregivers to easily and instantly deliver emergency medications via intramuscular injection. The system can administer drugs on bare skin or even through clothing, eliminating the need for traditional needle-based injections in critical situations.
CROSSJECT's ZEPIZURE addresses the critical need for rapid epileptic rescue therapy, where immediate treatment can be life-saving. The company's broader ZENEO platform is also being developed for other emergency indications, including solutions for allergic shocks and adrenal insufficiencies.
Regulatory Pathway Forward
The company continues to make progress toward meeting FDA requirements for both EUA and NDA submissions. The completion of validation batches and facility audits represents crucial steps in the regulatory pathway, demonstrating manufacturing readiness and quality standards necessary for approval.
The BARDA partnership, established under contract number 75A50122C00031, reflects the strategic importance of developing accessible emergency treatments for national health security. The funding supports CROSSJECT's mission to provide innovative solutions for emergency medical situations where rapid intervention is critical.
