Patrick Alexandre is Chairman of the Management Board of Crossject
Credit: Photo DR
Patrick Alexandre, Chairman of the Management Board of Crossject, comments: “We are extremely happy to now cooperate with BARDA. The selection and verification process was meticulous, and I congratulate the Crossject teams for this success. We have an order from the US government and an expedited FDA review will be requested. It will be a tremendous accelerator for Crossject. Making ZENEO Midazolam available to help victims of potential attacks with nerve agents is fully in line with our mission to ”simply save”. »
This contract was signed following a call for tenders by BARDA. It includes: financial support for R&D to meet regulatory requirements in preparation for filing an FDA application for ZENEO Midazolam for the treatment of status epilepticus (including seizures induced by neurotoxicants) in adult and pediatric populations (2 years and older) and an initial order by the United States government of ZENEO Midazolam for adult and pediatric populations. An Emergency Use Authorization request will be filed first, before a Marketing Authorization request (New Drug Application) is filed.
Under this contract, BARDA allocates to Crossject an initial order of $60 million for ZENEO Midazolam, upon FDA clearance. BARDA also has an option to purchase additional units, up to $59 million. The total value of the contract – if all options are exercised – would be $155 million. The ZENEO needle-free drug delivery device has undeniable advantages in the event of an event affecting many victims, such as accidental or deliberate exposure to nerve agents or organophosphate pesticides: speed of use in an emergency context major; reliability; no risk of cross-contamination; ease of disposal (no sharp objects, no volume of drug remaining after use), and absence of risk of needlestick injuries.
This project is supported, in whole or in part, by federal funds from the U.S. Department of Health and Human Services, the Office of the Assistant Secretary for Crisis Preparedness and Response, and the Authority for R&D advance in the biomedical field (BARDA).