What's Happening?
CROSSJECT, a global specialty pharmaceutical company, has received an additional $11.3 million in funding from the U.S. Biomedical Advanced Research and Development Authority (BARDA). This funding is aimed at advancing the development of ZEPIZURE (ZENEO Midazolam), a needle-free auto-injector designed for emergency situations. The total funding from BARDA now amounts to $43.3 million, supporting regulatory and manufacturing activities necessary for FDA Emergency Use Authorization (EUA) and New Drug Application (NDA) submissions. Recent progress includes the manufacturing of validation batches and the completion of a facility audit. Upon FDA approval, CROSSJECT is contracted to supply 306,000 adult and 54,000 pediatric ZENEO Midazolam autoinjectors, valued at $60.84 million.
Why It's Important?
The additional funding from BARDA underscores the strategic importance of ZEPIZURE in emergency medical response, particularly for the U.S. Strategic National Stockpile. This development is crucial for enhancing the country's preparedness for chemical emergencies, as ZEPIZURE is part of the CHEMPACK program. The needle-free technology of ZENEO offers a significant advantage in emergency situations, allowing for rapid and easy administration by untrained individuals. The successful development and authorization of ZEPIZURE could lead to broader applications of CROSSJECT's technology in other emergency medical scenarios, potentially benefiting public health and safety.
What's Next?
CROSSJECT is moving towards key regulatory milestones, with plans to submit for FDA EUA and NDA authorizations. The company is also preparing for commercial production, supported by its internal teams and manufacturing partners. The continued collaboration with BARDA is expected to facilitate these processes. Upon FDA approval, CROSSJECT will fulfill its contract to supply ZENEO Midazolam autoinjectors, contributing to the U.S. emergency medical stockpile. The company's progress will be closely monitored by stakeholders in the pharmaceutical and public health sectors.
