Significant Manufacturing Progress for Epilepsy Rescue Therapy
Crossject, a pioneering specialty pharmaceutical company, has been making substantial advancements in the manufacturing of its innovative epilepsy rescue therapy, ZEPIZURE®. This progress is crucial as the company gears up to file for Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA).
Recent Developments Supporting Regulatory Stability
In July, Crossject announced the successful completion of a product batch that provides essential regulatory stability data. This data will play a pivotal role in bolstering the six-month stability information required by the FDA in the coming first quarter.
Upcoming EUA Filing with the FDA
Looking ahead, Crossject plans to submit its EUA application early next year, with optimistic expectations for a positive response from the FDA soon after. This approval will be a significant milestone for the company, marking its first step toward fulfilling orders from the Biomedical Advanced Research and Development Authority (BARDA).
First Commercial Production Timeline
Crossject is also preparing for the manufacture of additional product batches, which will include its initial commercial batches in early 2025. This timeline aligns with expected deliveries to BARDA, ensuring that Crossject is well-positioned to respond to national preparedness needs.
Importance of Stability Data in Manufacturing
On July 18, the company achieved a crucial milestone in producing a new batch that will facilitate the generation of six months' worth of International Council for Harmonisation (ICH) stability data. This data is imperative for assessing the product's shelf life and supporting Crossject's upcoming EUA submission to the FDA.
Strategic Plans for Regulatory Compliance
Additionally, these manufactured batches, combined with Crossject’s forthcoming U.S. bioequivalence study, will form an integral part of the company’s New Drug Application filings that are expected to commence in 2025 and beyond.
Leaders' Insights on Manufacturing Achievements
Patrick Alexandre, the Chief Executive Officer of Crossject, expressed his pride in the company’s manufacturing journey. He stated, “Our strong manufacturing progress for ZEPIZURE® epilepsy rescue therapy positions us well for the imminent commercialization effort. We are diligently gathering all necessary data for a successful EUA application in the U.S. This regulatory step is vital for beginning our BARDA contract deliveries and forming the basis of our commercial strategies in the U.S.”
Promising Stability Data from Previous Clinical Batches
Earlier analyses of clinical batches have shown exceptional stability results even after 36 months. This trend raises expectations for future manufacturing outputs. Crossject has demonstrated a consistent and stable manufacturing process throughout 2024, fueled by a successful transition to Eurofins CDMO, which oversees the fill-and-finish operations for the product.
About Crossject
Crossject SA is redefining the landscape of emergency medications with its award-winning needle-free auto-injector, ZENEO®. The company is well into its regulatory journey for ZEPIZURE®, having secured a hefty $60 million contract with BARDA. This unique system allows patients and caregivers, regardless of training, to administer essential emergency medications swiftly and effectively, ensuring patient safety and care.
Contact Information for Inquiries
For inquiries, Crossject's investor relations can be reached via Natasha Drapeau at Cohesion Bureau, +41 76 823 75 27. Media relations can contact Sophie Baumont at Cohesion Bureau, +33 6 27 74 74 49.
Frequently Asked Questions
What is ZEPIZURE®?
ZEPIZURE® is an epilepsy rescue therapy developed by Crossject, designed for rapid administration during seizures.
Why is Crossject filing for EUA?
The EUA is essential for Crossject to receive regulatory approval to distribute ZEPIZURE® in the U.S. healthcare system.
What role does BARDA play in Crossject's strategy?
BARDA is a key partner for Crossject, providing funding and support for the development and delivery of ZEPIZURE® for emergency readiness.
When does Crossject expect to launch ZEPIZURE®?
Crossject anticipates filing for EUA early next year, with hopes to commence deliveries later in 2025.
What distinguishes Crossject from other pharmaceutical companies?
Crossject's innovative needle-free auto-injector technology sets it apart, enabling emergency medication delivery that is simple and effective.
