CROSSJECT’s Development in the United States

Furthermore, I firmly believe in the principle of “starting with the end in mind,” inspired by Stephen Covey’s book, “The 7 Habits of Highly Effective People”.

For me, the ultimate goal is fully realized commercialization with 2 achievements —delivering ZEPIZURE® to BARDA and making the product available in pharmacies for American epilepsy patients. These milestones represent both operational and financial successes.

From a commercialization perspective, the year  2025 will include  evaluation, analysis and strategy development  for ZEPIZURE® in the U.S. market. Although preliminary work has been completed, we must now update and deepen our efforts as we move closer to commercialization. The U.S. market is dynamic and constantly evolving, requiring us to remain agile and responsive.

Our evaluation phase will involve gathering essential insights through various market studies to collect data on sales, prescriptions, and insurance reimbursements.

This will help us address key questions such as:

  1. What is the optimal size of our sales team?
  2. What resources are necessary for a successful launch?
  3. How should we position ZEPIZURE® against competitors?
  4. What brand messaging will resonate most with our target audience?
  5. What pricing and payer contracting strategies will ensure patient access?
  6. Where are our greatest opportunities to grow our business at launch and beyond?


Once we have this information, we will move to the second phase, analyzing the data to define our commercial strategies. This phase will provide the necessary direction for laying the groundwork for a successful U.S. launch, pending FDA approval.

In summary, while the work ahead is substantial, we approach this journey with a structured and methodical plan. Our approach enables us to build a solid foundation and plan for ZEPIZURE®’s launch in the U.S. and ultimately deliver a life-saving product to patients.

What are the most significant challenges in preparing for pre-commercialization in the U.S.?

The challenges I foresee for CROSSJECT and CROSSJECT US are closely interconnected, as our overarching goal remains focused on the U.S. market. While the two organizations may share common objectives, they will encounter distinct challenges as we progress toward commercialization. However, these differences also present meaningful opportunities for growth and alignment.

Pre-commercialization challenges we face are similar to those experienced by most specialized pharmaceutical companies entering the U.S. market. The greatest challenge lies in balancing financial and human resources with the typical demands of a pre-commercial company. Successfully managing this balance is critical to the launch of ZEPIZURE®.

To tackle this challenge, Baya FODIL and I collaborate closely with Patrick ALEXANDRE and the leadership team in France. Our approach emphasizes aligned communication, trust, and shared objectives. By fostering these pillars, we maximize our chances of ensuring CROSSJECT and CROSSJECT US are well-prepared to meet U.S. market demands.

I see 2025 as a time to adopt a mindset of openness and possibility—a time to ask questions like, “How can we?” and “What if?”…

Finally, we must think without limits and explore innovative solutions to overcome resource constraints and maximize our impact on the U.S. market. In doing so, we can transform challenges into opportunities and lay the foundation for long-term success.

Baya FODIL

What excites you about preparing for ZEPIZURE®’s launch in the U.S.?

ZEPIZURE® will undoubtedly address a significant unmet medical need in epilepsy for patients whose chronic treatments fail to control seizures, leaving them with debilitating episodes. This represents potentially 40% of diagnosed patients in the U.S., with an estimated 4 million seizures per year.

Intramuscular midazolam has proven to be one of the first-line treatments for convulsive status epilepticus, with level A evidence for efficacy and safety. The two other recommended therapies are intravenous solutions, highlighting the administration advantage offered by ZEPIZURE®. These recommendations, published by the American Epilepsy Society in 2016, have not been updated despite the launch of a nasal spray. A large group of underserved patients still struggle with debilitating seizures daily.

Since beginning my collaboration with the U.S. epilepsy community in 2019, ZEPIZURE® has consistently generated enthusiasm and garnered significant expert support. This was recently confirmed during two advisory committees of leading U.S. epileptologists in 2024.

To illustrate my excitement, I’ll cite one expert’s inspiring vision and promising positioning for ZEPIZURE®, detailed in the publication REST (Rapid Epileptic Seizure Termination): “ZEPIZURE® has the potential to become the treatment for REST” and serve as the “EpiPen of the epilepsy market.”

What are the main pre-commercialization projects for ZEPIZURE® in 2025?

McKinsey published a well-documented strategic review titled “The Secret of Successful Drug Launches”. This review highlights that only 35% of drugs launched meet or exceed their first-year sales targets. The key to success lies in the level of preparation and the selection of pre-commercialization activities.

I have experienced this “secret of success” firsthand, having launched more than five central nervous system (CNS) drugs globally, including three in epilepsy, during my tenure at Pfizer and UCB. Here are the secrets described in McKinsey’s publication and how they apply to ZEPIZURE®:

  1. Aim for excellence
    Launching a drug requires a product that stands out from the competition and targets diseases with significant unmet needs. As mentioned earlier, ZEPIZURE® clearly falls into this category. Differentiated marketing activities will be addressed through advisory committees, market studies, and medical development plans in 2025.
  2. Stand out from the crowd
    This involves differentiation from competitors. ZENEO®, with its unique features as a device, fits perfectly within this approach.
  3. Create a new category
    One of the most significant medical-marketing challenges for 2025—and thus a primary focus—is defining a specific patient group for ZEPIZURE® that differs from the nasal spray segment. Medical experts, market analysis, and patient associations will help us identify this distinct new category.


Therefore, launching ZEPIZURE® will require much more than a generic intramuscular midazolam strategy aimed at capturing a small share of the current nasal spray market. ZEPIZURE® has the potential to create a new category in the seizure medication market, offering unique features.

Our pre-commercialization activities in 2025 will thus focus on product differentiation and identifying patient groups. Market analysis will help us understand specific needs and preferences, enabling the development of a marketing position and tailored messages for our target audience.

Another indispensable action before the launch, initiated six years ago with our first advisory board in 2019, is engagement with key opinion leaders (KOLs). Building relationships with these therapeutic area leaders can significantly impact a launch’s success. KOLs provide support, educate their peers, and influence prescribing patterns.

This year, we organized two advisory boards with the most recognized U.S. epilepsy experts and will continue this momentum in 2025 with even more engagements and activities around conferences and medical congresses.

Finally, I celebrate my 10th year at CROSSJECT this year. I am genuinely excited about finally offering ZEPIZURE® to American patients very soon!

Dan CHICHE

What are the key facts about epilepsy in the U.S.?

If epileptic seizures are common in the general population, they are usually brief (lasting around 1 or 2 minutes). They have no significant consequences and do not require emergency medication. However, repeated seizures (known as status epilepticus in English) warrant emergency treatment, most often with a benzodiazepine such as midazolam. Status epilepticus is a very serious condition, accounting for between 50,000 and 100,000 cases annually in the United States.

In the U.S., pre-hospital emergency care is highly variable. First responders have no direct equivalent in France. They are referred to as Paramedics, who are somewhat similar to operating room nurses in France, or Emergency Medical Technicians (EMTs), who are more comparable to first aid responders.

In this context, ZEPIZURE® offers a real added value due to its 10 mg dosage of midazolam and, more importantly, its ease of use, which enables the rapid management of repeated seizures and status epilepticus by allowing administration by the patient’s relatives or EMTs.

What is the importance of the HAZMAT human factors study in the R&D process?

In addition to a standard New Drug Application (NDA) submission to the FDA in the U.S., CROSSJECT is considering an approval request for extreme public health emergencies, such as a terrorist attack with nerve agents or a large-scale accidental poisoning.

In such scenarios, caregivers must wear HAZMAT (hazardous materials) equipment, which limits visibility and mobility. This is why ZEPIZURE® must be tested under these extreme conditions. For such circumstances, the approval process will use the Emergency Use Authorization (EUA) pathway.

What are the key clinical development milestones for ZEPIZURE® in 2025?

The most critical study planned for 2025 is a clinical pharmacology study, or phase 1 trial, where ZEPIZURE® will be compared to another FDA-approved intramuscular midazolam formulation. We are highly confident that this study will yield positive results and support the straightforward registration pathway chosen by CROSSJECT and its advisors.

Many other topics are on the table, primarily based on expert opinions (neurologists, epileptologists, or emergency physicians) and mathematical tools to create models and conduct simulations. These approaches include justifying ZEPIZURE®’s use by non-professionals and its application in pediatrics, among others.