French company Crossject has secured €6.9m in funding to advance the development of ZENEO Epinephrine, its prefilled needle-free platform and treatment for severe allergic reactions.
Crossject received funds from the French Government as part of the "i-Démo" call for projects under the France 2030 Plan, operated by Bpifrance on behalf of the government.
ZENEO Epinephrine is expected to generate cumulative sales of around €1bn by 2032 for Crossject and its distributors, according to the 11 July announcement.
The company’s needle-free platform is designed to enable patients or untrained caregivers to deliver a range of emergency drugs via intramuscular (IM) injection on the skin or through clothing. According to Crossject, the single-use device propels the medicine through the skin in less than a tenth of a second.
Speaking to Medical Device Network, Crossject’s CEO Patrick Alexandre said that this is an advantage over other needle-based systems on the market, which take more time in emergencies and have more variability in dosing.
“It takes less than one minute to understand and perform the injection, which is key for an emergency,” explained Alexandre.
The drug solution inside ZENEO Epinephrine uses a sulfite-free formulation. Sulfites are used as preservatives in many products and can cause intolerance or even additional allergic reactions such as anaphylactic shock. According to Alexandre, this new solution – which replaces sulfite with vitamin E – minimises additional allergy risks to patients.
As well as ZENEO Epinephrine, the company has other assets such as ZEPIZURE, a rescue therapy for epileptic seizures. In 2022, Crossject teamed up with the US Biomedical Advanced Research and Development Authority (BARDA), which placed an initial $60m order for ZEPIZURE once it gained US Food and Drug Administration (FDA) approval.
BARDA funded a study of midazolam, the drug used in ZEPIZURE.
“When we decided to develop a drug-device combination, we first choose drugs that are already used in a specific indication – for example, midazolam is already a first choice as an intramuscular injection in case of epileptic seizures,” said Alexandre.
Data from the RAMPART study demonstrated IM midazolam’s non-inferiority compared to intravenous lorazepam, as its primary endpoint. In a bioequivalence study from Crossject, ZEPIZURE was equivalent to the IM injection from a syringe equipped with a 30mm needle.
The company plans to file marketing authorisation applications for ZENEO Epinephrine in 2026 with regulatory authorities in Europe and the US.
According to GlobalData analysis, Crossject is a key player involved in the active development of needle-free injections.
Needle-free delivery mechanisms are increasing in popularity, offering an alternative to traditional needles which can require training to administer. In November 2023, US-based Micron Biomedical received $23.6m in funding from the Bill & Melinda Gates Foundation for the bulk manufacturing of needle-free vaccines.
