CROSSJECT achieves key ZEPIZURE® manufacturing batch stability milestones
Press Release
CROSSJECT achieves key ZEPIZURE® manufacturing batch stability milestones
- Satisfactory 6-month room temperature stability results for the Registration Batch of ZEPIZURE®;
- CDMO Partner EUROFINS in the process of producing additional validation batches as part of regulatory application;
- Manufacturing progress supports timelines toward filing of Emergency Use Authorization application by BARDA.
Dijon, France March 18, 2025
CROSSJECT (ISIN: FR0011716265; Euronext: ALCJ), a specialty pharma company in advanced phases of development and registration for ZEPIZURE®, announces the successful collection of stability data on its latest Registration Batch of ZEPIZURE®, produced at EUROFINS’ qualified facility in July 2024. ZEPIZURE® is an emergency treatment for the management of epileptic crisis based on its award-winning needle-free auto-injector ZENEO®.
The 6-month room temperature stability on this batch adds to the nine-month data accumulated on a previous batch produced by EUROFINS in December 2023. CROSSJECT has also reported several positive audits of the manufacturing sites that have been performed in anticipation of potential inspections that the U.S. Food and Drug Administration may conduct under the EUA expedited process.
Manufacturing batches are critical parts of the dossier needed for submission to FDA to consider EUA of ZEPIZURE®. This data will also be part of the dossier of the NDA filing for the approval of ZEPIZURE® for the US market.
“We are pleased with this positive manufacturing data which, together with the pending data on validation batches, allows our U.S. partner to complement the electronic dossier of ZEPIZURE®. These data also strengthen our relationship with EUROFINS and highlight the hard work and dedication of both teams over the last months”, said Patrick ALEXANDRE, CEO of CROSSJECT.
Patrick ALEXANDRE, CEO of CROSSJECT added: “This data is a critical step that further builds on our manufacturing know-how and the versatility of the ZENEO® platform. If approved, the planned procurement of ZEPIZURE® could increase U.S. national preparedness against chemical threats while broadening the availability of the ZENEO needle-free auto-injectors.”
About CROSSJECT
CROSSJECT SA (Euronext: ALCJ; ) is an emerging specialty pharmaceuticals company developing medicines for emergency situations harnessing its award-winning needle-free auto-injector ZENEO® platform. CROSSJECT is in advanced regulatory development for ZEPIZURE®, an epileptic rescue therapy, for which it has a $60 million contract* with the U.S. Biomedical Advanced Research and Development Authority (BARDA). The Company’s versatile ZENEO® platform is designed to enable patients or untrained caregivers to easily and instantly deliver a broad range of emergency drugs via intramuscular injection on bare skin or even through clothing. The Company’s other products in development include mainly solutions for allergic shocks and adrenal insufficiencies, as well as therapies and other emergency indications.
* This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50122C00031.
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