Zepizure (midazolam auto-injector) / Crossject, AFT Pharma - LARVOL DELTA

Midazolam Needle-Free Auto Injector: Demonstration of Intramuscular Injection by MRI and of no Impact of Subcutaneous Fraction on Midazolam Exposure (AES 2025) - "ZENEO® is expected to deliver midazolam IM in most patients, in emergency situation, on thigh either on bare skin or through clothing. While the IM injection has been demonstrated, a mixed IM/SC dosing has negligible impact on midazolam pharmacokinetics.This analysis indicates that ZEPIZURE® features are consistent with its use in SE in emergency situation, with benefits of midazolam intramuscular injection while variations in the IM/SC fraction are very unlikely to be associated with a clinically relevant impact on safety or efficacy."

Epilepsy

CROSSJECT provides updates on the EUA filing of ZEPIZURE (GlobeNewswire) - "CROSSJECT...provides an update on the process for the dossier filing of ZEPIZURE to the FDA under the Emergency Use Authorization, in agreement with its U.S. partner, the Biomedical Advanced Research and Development Authority (BARDA) within the U.S. Department of Health and Human Services....The publishing activities for the ZEPIZURE dossier submission have started, and the final manufacturing data will be inserted as soon as available. Initial feedback from the FDA, limited to confirmation of positive reception of a complete dossier, is expected within one month of the submission. Moreover, CROSSJECT began manufacturing EUA batches, intended as the first delivery to the CHEMPACK program."

FDA event • CNS Disorders • Epilepsy

Crossject signs a geographic extension of ZEPIZURE commercialization agreement in Europe (GlobeNewswire) - "Crossject...announces it has extended the geographic coverage of its 22nd December 2023 commercialization agreement with an undisclosed partner for its innovative rescue therapy for epileptic seizures ZEPIZURE, previously known as ZENEO Midazolam. The extended contract now covers a total of 11 European countries. As a reminder, under the terms of the agreement, Crossject will receive milestone payments of up to €1 million in total, upon marketing authorizations granted in the territories. Crossject will sell ZEPIZURE to the partner with a markup that is a share of the gross margin (net sales from the partner into the markets minus cost of goods)."

Commercial • CNS Disorders • Epilepsy

Crossject signs new licensing agreement on ZENEO Midazolam epilepsy rescue therapy with AFT Pharmaceuticals for Australia & New Zealand (GlobeNewswire) - "Crossject...announces the signing of an Australia & New Zealand commercial agreement for ZENEO® Midazolam, its innovative rescue treatment of epileptic seizures...Under the terms of the agreement, AFT will be responsible for all local regulatory and commercial activities. In exchange for the commercial rights, Crossject shall receive: about €0.5m (AUD 0.79m) of premarketing payments from AFT. About €150k (AUD 237k) is due after the signature of the agreement."

Licensing / partnership • CNS Disorders • Epilepsy

CROSSJECT - CLINICAL DEMONSTRATION OF ZENEO EFFICIENCY FOR INTRAMUSCULAR INJECTION OF MIDAZOLAM (GlobeNewswire) - P1 | N=40 | NCT05026567 | Sponsor: Crossject | "CROSSJECT...is releasing positive headline results of its clinical study with ZENEO® midazolam. The 4-period, crossover and randomized study was conducted on 40 healthy subjects, with gender, ethnicity and BMI1 diversity (ref ClinicalTrials.gov Identifier NCT05026567). The primary objective was met. It was the evaluation of the relative bioavailability of midazolam after injection with the needle-free autoinjector ZENEO® (10mg midazolam in 0.625mL) compared to injection of DORMICUM® (10mg midazolam in 2mL) by a conventional syringe with a 30mm needle, into the thigh on bare skin. The bioequivalence was achieved both on Cmax2 and on AUC3, with no change of Tmax4. The 90% Confidence Intervals were respectively of [84-98] for Cmax ratio, and [100-108] for AUC ratio."

P1 data • CNS Disorders • Epilepsy

ZENEO Midazolam clinical study: completion of the injection phase (Market Screener) - "CROSSJECT...announces the end of the injection phase of the bioequivalence clinical study for ZENEO® Midazolam. All injections of ZENEO® Midazolam planned as part of the clinical bioequivalence study have been completed on schedule."

Trial status • CNS Disorders • Epilepsy

CROSSJECT: Agreement with BARDA on ZENEO Midazolam (GlobeNewswire) - "CROSSJECT...is announcing an agreement with BARDA on ZENEO® Midazolam....As part of this contract, BARDA awarded $60 million to Crossject for an initial order of ZENEO® Midazolam as soon as the product is authorized by the FDA. BARDA also has an option for the acquisition of additional units, up to $59 million. The total contract value if all options are exercised is $155 million."

Licensing / partnership • CNS Disorders • Epilepsy