When we founded CROSSJECT, our promise could be summed up in three words: to save lives. Twenty-five years later, that promise remains unchanged. What has changed is the robustness we have built at every level to fulfill that commitment. Building this robustness has indeed been a key thread running through our journey. And I want to share its various facets here, so that everyone—employees, partners, and shareholders—can understand where we’ve come from and where we’re headed.
First and foremost, this robustness is based on solid and ambitious partnerships. This is clearly the case with the BARDA* contract, which has just signed an amendment consolidating the pediatric development plan for ZEPIZURE® in accordance with the FDA’s expectations. This amendment brings the total value of the contract to over $170 million if all options are exercised. Behind this figure lies a strong signal: a leading U.S. regulatory agency is supporting our program over the long term—from adults to children—and reaffirming its confidence in the role that ZEPIZURE® is set to play in emergency response in the United States. For us, having started in a laboratory in Dijon, this public trust is an immense responsibility and a source of daily commitment.
Next, we demonstrate its robustness. While traditional players typically settle for formal efficiency—tested under basic conditions—CROSSJECT goes much further. In fact, we put ZENEO® through its paces in real-world scenarios, under particularly demanding conditions. This is the very purpose of our Human Factors studies, and the “Focus” section of this newsletter takes you behind the scenes of the most demanding of these studies. I invite you to read it carefully: it is here that you can see, under crisis conditions, what the ZENEO® solution offers both to the rescuer and to the person being rescued.
Robustness is also part of a quality system that goes beyond regulatory requirements. We have voluntarily sought ISO 13485 certification for the design and manufacture of our medical devices, in addition to all applicable standards, such as the French Defense Code, U.S. regulation 21 CFR Part 820, and Good Manufacturing Practices (GMP) for pharmaceuticals. All our operations—both in-house and outsourced—are subject to rigorous and systematic oversight. We do not wait for regulations to compel us to do so: quality is a culture before it is a matter of compliance.
Robustness is also built right here in our region. We have brought all of our strategic expertise in-house and surrounded this industrial base with subcontractors located less than two hours from our sites in Dijon and Gray. This proximity allows us to resolve any issues very quickly, to benefit from exceptional expertise, and to avoid the tensions of global supply chains in the event of an international crisis. We have chosen to be a manufacturer as well as a drug developer: control over our technology depends on control over our production. Our partners have supported us from the start, invest alongside us, and share our ambition.
Finally, robustness takes on many forms in our R&D process. We combine a technological breakthrough—the ZENEO® needle-free autoinjector—with proven, royalty-free molecules whose therapeutic efficacy is well established. Our development teams thus focus their efforts where our value lies: the significant benefit to patients from using ZENEO® in the management of their condition.
And because a good product alone is not enough, our strength also lies in our cost-effectiveness: CROSSJECT selects its distribution model on a disease-by-disease approach. Licensed pharmaceutical partnerships remain our primary model, with the direct distribution of ZEPIZURE® in the United States serving as a well-considered exception, made possible by the unique characteristics of that market. We do not simply accept our model—we choose it.
Long-term institutional partnerships, real-world demonstrations, high quality standards, a resilient industry, focused R&D, and an adaptive business model: six facets of a single conviction. To those who follow us, I want to say this: our robustness is how we ensure the life-saving intervention.
Patrick Alexandre
Founder and CEO of CROSSJECT
*Biomedical Advanced Research and Development Authority – Contract No. 75A50122C00031