Press Release

Crossject engages Syneos Health for
U.S. commercial launch of ZEPIZURE^®

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Crossject expanding market access activities in preparation for filing for marketing authorization

ZEPIZURE^®, previously known as ZENEO^® Midazolam, is separately contracted with BARDA for U.S. advanced regulatory development and specific supply to the Strategic National Stockpile

Dijon, France, January 4, 2024, 18:00 CET -- Crossject (ISIN: FR0011716265; uronext: ALCJ), a specialty pharma company developing needle-free auto-injectors for emergency situations, has engaged Syneos Health, a leading fully integrated biopharmaceutical solutions organization, to prepare for the commercial launch of Crossject’s ZEPIZURE® innovative rescue therapy for epileptic seizures in the U.S.

Under the agreement, Syneos Health will provide support in all pre-launch and launch activities for ZEPIZURE®. Syneos Health brings a strong U.S. presence and significant expertise in commercializing new therapies for Crossject.

In 2022, Crossject was awarded a contract with the U.S. Biomedical Advanced Research and Development Authority (BARDA) for the U.S. advanced regulatory development and procurement of ZEPIZURE® into the Strategic National Stockpile (SNS), upon receiving Food and Drug Administration (FDA) authorization. Under the terms of the contract, BARDA will sponsor the licensure and SNS stockpiling, and Crossject will sell the therapies directly into the epilepsy medical market.

“ZEPIZURE® is a unique treatment which could save lives in an emergency, as it can potentially be administered anywhere and by anyone, in a matter of seconds,” said Patrick Alexandre, CEO of Crossject. “We are now focusing on preparing the filing for marketing authorization with the FDA, and we are pleased to have such an experienced partner as Syneos Health to guide us through and launch our commercial activities in the U.S.”

ZEPIZURE® is based on Crossject’s proprietary needle-free device ZENEO®, which is designed to enable easily administered injections to be delivered in a fraction of a second in emergency situations.

“We have reached an advanced stage in development of ZEPIZURE®, and the approaching regulatory filing is driving a need for local marketing in the U.S., where we are also expanding Crossject’s presence. I am looking forward to working closely with Syneos Health, who will provide important momentum and awareness of our groundbreaking product and help to ensure it reaches patients in need in the most efficient manner,” said Daniel Teper, a U.S. based member of the Crossject Supervisory Board.

“We are pleased to support Crossject on the launch of this exciting emergency treatment for epilepsy,” said Lee Taurman, Executive Vice President, Syneos One, Syneos Health. “ZEPIZURE can be significant for people suffering from epileptic seizures. We look forward to working closely with Daniel Teper and the rest of the Crossject team to optimize the launch and commercialization for this product.”

About Crossject

Crossject SA (Euronext: ALCJ; www.crossject.com) is an emerging specialty pharma company based in France and the U.S. It is in advanced regulatory development for ZEPIZURE®, an epileptic rescue therapy, for which it was awarded a $60 million contract with the U.S. Biomedical Advanced Research and Development Authority (BARDA). ZEPIZURE® is based on the Company’s award-winning needle-free autoinjector ZENEO®, designed to enable patients and untrained caregivers to easily and instantly deliver emergency medication via intramuscular injection on bare skin or even through clothing. The Company’s other products in development include rescue therapies for allergic shocks, adrenal insufficiencies, opioid overdose and asthma attacks.

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