Crossject reports financial results and business highlights for first half of 2023 - Seite 2

Appointment of Daniel Teper as a member of the Supervisory Board

With a PhD in Pharmacy from Paris-Saclay University and an MBA from INSEAD, Daniel Teper is a U.S.-based pharmaceutical industry leader and entrepreneur with a compelling background spanning the fields of marketing, capital markets, strategy and development.

hErOiSme² project

The French Ministry of Armed Forces (Ministère des Armées) selected the project offered by a research consortium to develop a new molecule for rescue therapies for hemorrhagic shock treatment with ZENEO auto-injector. Many civilian and military lives could be saved by promptly stabilizing the condition of a person suffering from hemorrhagic shocks. Crossject and IDD, its long-term regulatory partner, have officially joined this 3-year-long research program with a total budget of €800,000.

Events beyond the reporting period

New licensing agreement on ZENEO Midazolam epilepsy rescue therapy

Crossject signed an Australia & New Zealand commercial agreement with AFT Pharmaceuticals for ZENEO Midazolam, its innovative rescue therapy for epileptic seizures. AFT Pharmaceuticals is a particularly well-suited partner because of its strong regional presence and extensive experience with successful commercial launches.

Successful completion of European and U.S. audits

Crossject's manufacturing sites in Dijon and Gray (France) passed an annual ISO certification audit, expanded their scope of certification by the French Health Agency, and received positive feedback after an audit by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, on compliance of manufacturing ZENEO Midazolam for the U.S. market.

In 2022, Crossject was awarded a $60 million contract with the U.S. Biomedical Advanced Research and Development Authority (BARDA) to procure ZEPIZURE for nerve agent-induced epileptic seizures upon receiving FDA authorization. BARDA is also funding the US advanced regulatory development until FDA Emergency Use Authorization and New Drug Approval and has options for further procurement for a total contract value of $155 million if all options are exercised.