In 2016, a partnership was entered into between Cenexi and Crossject, a start-up developing self-administered emergency medication and medical devices with a view to their marketing. After the validation of the clinical batch of ZENEO® Midazolam 10 mg last December, a new milestone has just been reached with the announcement of the conformity of the first industrial transposition batch (necessary prior to starting the validation program) of ZENEO® Hydrocortisone (acute adrenal insufficiency). Following this production, Cenexi teams at Braine-Alleud will be able to launch the validation batches, a step prior to the Marketing Authorization Application (MAA) scheduled for 2023.
As a reminder, Crossject has developed ZENEO®, a very innovative needle-free injection system covered by over 400 patents. Cenexi, and, more particularly, its Braine-Alleud site (Belgium), has recognized expertise in designing sterile processes, and Crossjet worked with the Group on container filling technology. As such, the Group supports this laboratory in developing, filling, assembling, and packaging its needle-free auto-injector.
In May 2021, when the industrial ramp-up stage began, the partnership was strengthened with a new agreement synchronizing activities for the industrial production and large scale marketing of this innovative device.
Thanks to major, complex development phases, another key step has been completed with the production and validation of a new ZENEO® product. This production was made possible by a new, patented filling process using equipment specifically designed to meet the specific characteristics of the auto-injector components.
This success supports Cenexi’s strategy to become a long-term industrial partner: the Group is effectively in charge of producing the commercial batches and filling ZENEO® with the eight drugs currently used with it.
It also strengthens its positioning as the privileged CDMO of innovative biotechs.
