Crossject Triumphs: Secures European and U.S. Manufacturing Audits for ZENEO® Midazolam in Treating Epileptic Seizures

Crossject Achieves Manufacturing Milestones: Gains ISO Certifications, FDA Audit Readiness, and ANSM Authorization

Dijon, France, September 5, 2023 – Crossject (ISIN: FR0011716265; Euronext: ALCJ), the pioneering specialty pharma company behind needle-free autoinjectors for critical situations, is celebrating a triumphant series of accomplishments on both sides of the Atlantic.

In an impressive display of quality and compliance, Crossject’s manufacturing sites in Dijon and Gray, France, have not only secured their annual ISO certification but have also expanded their scope of certification by the French Health Agency. Simultaneously, they have garnered resounding praise following an audit by the Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services. This audit has certified their impeccable standards in manufacturing ZENEO® Midazolam for the U.S. market.

Patrick Alexandre, Crossject’s visionary CEO, emphasized the significance of these achievements, stating, “These endorsements from both sides of the Atlantic underline Crossject’s unwavering commitment to stringent manufacturing and quality standards. This commitment is vital as we endeavor to maintain the highest quality while bringing life-saving products to the markets in Europe and the United States.”

ZENEO® Midazolam, one of Crossject’s groundbreaking innovations, promises a novel and reliable means of administering emergency treatment for status epilepticus seizures. It offers rapid and precise delivery of life-saving medicine, and these certifications position Crossject to expand its manufacturing capacity, positioning the company as a global leader in the self-administration of emergency needle-free injectables.

Crossject’s preparation for FDA scrutiny has been meticulous, with preparatory audits conducted as part of the contract with BARDA (#75A50122C00031). These audits ensure compliance with cGMP, as stipulated by the U.S. Food and Drug Administration, and readiness for a potential FDA audit. The outcome of these audits is a resounding success, with no critical or major observations.

Notably, Crossject secured a $60 million contract with BARDA for the procurement of ZENEO® Midazolam upon FDA clearance, with options that could extend the contract value up to $155 million if all options are exercised.

In addition to these achievements, the British Standards Institution (BSI) Notified Body renewed Crossject’s ISO 13485 certification, affirming compliance with internationally recognized standards across the entire life cycle of the ZENEO® needle-free injection system at their manufacturing sites in Dijon and Gray.

Moreover, Crossject received a significant boost from the French National Agency for the Safety of Medicines and Health (ANSM), which upgraded the company’s manufacturer’s authorization, allowing for the transition from initial clinical to commercial medicinal product use. This pivotal milestone marks Crossject’s commitment to delivering life-saving solutions to those in need.

About Crossject

Crossject SA is on a mission to transform emergency care. They are poised to introduce a groundbreaking portfolio of life-saving drugs tailored for critical situations, spanning from epilepsy and overdose to severe migraine and asthma attacks. What sets Crossject apart is its innovative patented needle-free self-injection system, poised to revolutionize the way we administer emergency medications.

This dynamic company, a fixture on the Euronext Growth market in Paris since 2014, is not just about innovation—it’s about redefining how we respond to emergencies. And with backing from Bpifrance, Crossject is well-positioned to lead the charge in the world of self-administered emergency medications.

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