Operational phase cooperation between a BARDA and Crossject debuted in July
Dijon, 19 September 2022
CROSSJECT (ISIN: FR0011716265; Mnemo: ALCJ), a “specialty pharmaceutical company” developing and soon to market a portfolio of medicines combined dedicated to emergency situations, announces that the operational phase of the collaboration between BARDA1 and Crossject debuted in July.
On June 17, 2022, Crossject signed the contract2 with BARDA on ZENEO® Midazolam. In this context, the operational phase of the cooperation between BARDA and Crossject started in July.
In addition to regular meetings every two weeks, a BARDA delegation came to Europe in August to discuss the project and visit the Crossject headquarters and the three main ZENEO® Midazolam production plants.
In addition, Crossject invoices BARDA monthly for contractual activities related to the advanced regulatory development of ZENEO® Midazolam.
BARDA funding includes:
- up to $32 million for research and advanced clinical development studies in pursuit of regulatory approval – emergency use authorization (EUA3) and full approval (NDA4) – for ZENEO® Midazolam autoinjectors for the adult and pediatric population in the treatment of Status Epilepticus seizures (which may be caused by nerve agents);
- US Government orders for ZENEO® Midazolam auto-injectors for adults and children valued at $60 million, billed as shipped;
- options to be exercised by the U.S. Government for additional orders for the supply of ZENEO® Midazolam up to $59 million and up to $3 million in post-market commitments pursuant to US Food and Drug Administration (FDA).
The total value of the contract is $155 million if all options are exercised.
This project is funded in whole or in part by federal funds Strategic Preparedness and Response Report (ASPR), Office for Advanced Biomedical Research and Development (BARDA), on the basis of contract No. 75A50122C00031.
Next publication: September 20, 2022 (after market close): 2022 half-year results
ABOUT CROSSJECT • www.crossject.com
Crossject (ISIN code: FR0011716265; Mnemo: ALCJ; LEI: 969500W1VTFNL2D85A65) is developing and will soon launch a portfolio of medicines for emergency situations: epilepsy, overdose, allergic shock, severe migraine, asthma attack… Thanks to its patented needle-free self-injection system , Crossject aims to become a world leader in self-administered emergency medicine. The company has been listed on the Paris Euronext Growth market since 2014 and benefits from financing by the American BARDA (Office for Advanced Biomedical Research and Development) and especially Bpifrance.
1 Office for Advanced Biomedical Research and Development
2 See press release of 18 June 2022
3 Emergency use permit
4 New drug application
CROSSJECT_ The operational phase of the collaboration between BARDA and Crossject started in July.VersionDEF