Agreement with BARDA
on ZENEO® Midazolam
- BARDA places a firm order of $60m to CROSSJECT for initial procurement of ZENEO® Midazolam into the U.S. Strategic National Stockpile1 as soon as FDA Authorization is obtained
- BARDA also financially supports the U.S. late-stage development and regulatory activities necessary to obtain FDA approval of ZENEO® Midazolam 10mg and a new pediatric dose ZENEO® Midazolam auto injector
- BARDA has the option to procure additional ZENEO® Midazolam auto injectors from CROSSJECT
Dijon, June 18th 2022
CROSSJECT (ISIN: FR0011716265; Ticker: ALCJ), a specialty pharma company that is developing and will soon be marketing a portfolio of drug / device combinations for use in emergency situations, is announcing an agreement with BARDA on ZENEO® Midazolam.
Patrick Alexandre, Crossject CEO, said: “We are thrilled to be cooperating with BARDA now! The selection and due diligence process was thorough, and I am proud of Crossject’s teams for this success. We have an order from the U.S. Government in–hand, and will request an expedited review from the FDA, which is a tremendous accelerator for Crossject. Having ZENEO® Midazolam available to potentially help victims of nerve agent attacks is fully in line with our mission of Saving Lives Simply”.
This contract has been signed following a public Request for Proposals2 from BARDA, and it supports: (1) advanced research and development and regulatory requirements to submit an application to the FDA for approval of ZENEO® Midazolam for the treatment of Status Epilepticus (including nerve agent-induced seizures) for adult and pediatric (2+ years) populations; and (2) an initial delivery order of adult and pediatric ZENEO® Midazolam to the United States government. A request for Emergency Use Authorization (EUA)3 will initially be sought prior to submitting a request for approval (New Drug Application).
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.
ZENEO®’s needle-free drug delivery provides compelling advantages in a mass-casualty event like an accidental or deliberate exposure to nerve agents or organophosphate pesticides: speed of use in a context of a major emergency; reliability; avoidance of cross contamination risk; simplification of disposal (no sharps, no unused volume of drugs remaining); and prevention of needle-stick injuries.
This project is supported in whole or in part with federal funds from the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under Contract No. 75A50122C00031.
The Biomedical Advanced Research and Development Authority provides an integrated, systematic approach to the development of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies such as chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks; pandemic influenza; and emerging infectious diseases.
About CROSSJECT • www.crossject.com
Crossject (ISIN: FR0011716265; Ticker: ALCJ; LEI: 969500W1VTFNL2D85A65) is developing and is soon to market a portfolio of drugs dedicated to emergency situations: epilepsy, overdose, allergic shock, severe migraine and asthma attack. Thanks to its patented needle-free self-injection system, Crossject aims to become the world leader in self-administered emergency drugs. The Company has been listed on Euronext Growth Paris since 2014, and benefits from Bpifrance funding.
About ZENEO® Midazolam
ZENEO® Midazolam is developed as a combination of the single use needle-free auto injector ZENEO® and the drug product midazolam, which is an improved anti-convulsant benzodiazepine recommended for treatment of strong seizures resulting from epilepsia or from nerve agent absorption.
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1 Strategic National Stockpile (SNS): The US government has a requirement to acquire, hold, and distribute medical countermeasures that will mitigate injuries caused by chemical, biological, physical radiologic and nuclear exposures. The department of Health and Human Services has the responsibility of maintaining a definitive supply of medical Countermeasures for use in public health emergencies. In 2003, The Strategic National Stockpile created the CHEMPACK Program to acquire nerve agent antidotes and provide them to the 50 states, four cities, and several territories for prepositioning in locations that are convenient for responders. CHEMPACKs supplement the supply of these antidotes available in local hospitals, Emergency Medical Services systems, and other local response organizations.
3 The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the US public health protections against chemical, biological, radiological, and nuclear (CBRN) threats including infectious diseases, by facilitating the availability and use of not yet approved medical countermeasures needed during public health emergencies.