Operational phase cooperation between the BARDA and Crossject debuted in July
Dijon, September 19, 2022
CROSSJECT (ISIN: FR0011716265; Mnemo: ALCJ), a “specialty pharma” developing and soon to market portfolio of drugs combined dedicated to emergency situations, announces that the operational phase of cooperation between BARDA1 and Crossject debuted in July.
On June 17, 2022, Crossject signed the contract2 from BARDA to ZENEO® Midazolam. In this context, the operational phase of the cooperation between BARDA and Crossject started in July.
In addition to regular fortnightly meetings, a BARDA delegation came to Europe in August to discuss the project and visit Crossject’s headquarters and the three main production sites of ZENEO® Midazolam.
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 seeking 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 pediatric auto-injectors valued at $60 million, billed at shipment;
- options, to be exercised by the US government, for additional purchase orders for ZENEO® Midazolam up to $59 million and up to $3 million in post-marketing obligations 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 fully or partially funded by federal funds from Directorate for Strategic Preparedness and Response (ASPR), Administration for Advanced Biomedical Research and Development (BARDA), under contract number 75A50122C00031.
Next publication: 20 September 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 market a portfolio of drugs intended for emergency situations: epilepsy, overdose, allergic shock, severe migraine attack system… Thanks to its asthma attack system Needle-free self-injection , Crossject aims to become the world leader in self-injection of emergency drugs. The company has been listed on the Euronext Growth Paris market since 2014 and benefits from funding from the US BARDA (Administration for Advanced Biomedical Research and Development) and Bpifrance in particular.
1 Administration for Advanced Biomedical Research and Development
2 See the press release of June 18, 2022
3 Approval for emergency use
4 New medication app
CROSSJECT_ The operational phase of the cooperation between BARDA and Crossject started in July.VersionDEF