Crossject achieves key ZEPIZURE® manufacturing milestone

• Successful completion of an additional Registration Batch of ZEPIZURE® at new manufacturing site
• Milestone complements the satisfying results from previous batches under stability studies, and is part of the positive manufacturing data generated since 2021
• Manufacturing progress supports timelines toward granting of Emergency Use Authorization (EUA)
  
  

Dijon, France, July 18, 2024, 07:30 CET -- CROSSJECT (ISIN: FR0011716265; Euronext: ALCJ), a specialty pharma company in advanced phases of development and registration for ZEPIZURE®, its emergency treatment for the management of epileptic crises based on its award-winning needle-free auto-injector ZENEO®, announces the successful completion of a new registration batch of ZEPIZURE®, at Eurofins’ qualified facility, which is designated to be the CDMO partner that will ensure fill and finish activities for the deliveries to the U.S. Biomedical Advanced Research and Development Authority (BARDA).

This milestone follows a previous batch produced on the same filling equipment in December 2023, which delivered good results. It is part of the ZEPIZURE® manufacturing program, which includes several batches from its commercial site, aimed at confirming, among other parameters, the shelf-life of ZEPIZURE®. These new advances are in line with previous long-term stability data.

Manufacturing batches are critical parts of the dossier that will be submitted to the U.S. Food and Drug Administration (FDA) to support ZEPIZURE®’s application for EUA. Combined with our upcoming U.S. bioequivalence study, they will also form the bedrock of our future New Drug Application filings from 2025 onward.

Completion of this registration batch now paves the way for gathering new data, which will further demonstrate the quality of the products manufactured with the new equipment and ensure their satisfactory regulatory standing for widespread commercial use, starting with its delivery to the U.S. Government for national preparedness. Crossject is targeting its next milestones with the FDA regarding EUA of ZEPIZURE® for status epilepticus seizures in Q1 2025.

"We are very pleased with the progress in setting-up a new CDMO partner, increasing fill-and-finish capabilities for ZENEO®. The successful production of this registration batch, as well as the earlier batches, are a testament to the hard work and dedication of both teams over the last 18 months. Beyond ZEPIZURE®, these achievements in our manufacturing process, regulatory standing and industrial scale-up truly have strategic value as a prelude to a broad deployment of our ZENEO® technology in epilepsy and in our other targeted market opportunities,” said Patrick Alexandre, CEO of Crossject.

About Crossject

Crossject SA (Euronext: ALCJ; www.crossject.com) 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.

* Contract no: 75A50122C00031 with the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Research and Development Authority

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