(News Bulletin 247) – Crossject rose by almost 7% on the Paris Stock Exchange on Tuesday after successfully passing European and American audits for the manufacture of its auto-injector for the treatment of epileptic seizures.
The company announced this morning that its French production sites based in Dijon and Gray had received a positive assessment following the audit conducted by the American Biomedical Advanced R&D Authority (BARDA) on the compliance of manufacturing the system for the US market.
‘The success of these audits once again demonstrates the rigorous standards of the group’s manufacturing systems’, analysts at Invest Securities reacted this morning.
For the record, the company has signed a $60 million contract with BARDA for the supply of the Zeneo Midazolam needle-free injection system as soon as the authorization from the FDA, the American health authority, is expected by the end of the year.
Under the terms of the contract, BARDA also has the option to purchase additional units, for a maximum amount of $59 million.
The total contract value, if all options are exercised, is $155 million.
The two Crossject sites have also successfully passed an annual ISO certification audit and extended their scope of certification by the National Agency for the Safety of Medicines and Health Products (ANSM).
In addition, the notified body British Standards Institution (BSI) renewed its ISO certification following its annual audit of Crossject’s quality systems.
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