Crossject signs new licensing agreement on ZENEO® Midazolam epilepsy rescue therapy with AFT Pharmaceuticals for Australia & New Zealand

Press Release

Crossject signs new licensing agreement on ZENEO® Midazolam epilepsy rescue therapy with AFT Pharmaceuticals for Australia & New Zealand

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Exclusive licensing, distribution and promotion agreement for ZENEO® Midazolam in epileptic seizures in Australia and New Zealand

Pre-marketing payments of about €0.5m due to Crossject from AFT

Dijon, France 20 July 2023 — Crossject (ISIN: FR0011716265; Euronext: ALCJ), a specialty pharma company that develops and will soon market a portfolio of drug device combinations for use in emergency situations, announces the signing of an Australia & New Zealand commercial agreement for ZENEO® Midazolam, its innovative rescue treatment of epileptic seizures.

‘‘We are pleased to expand our ongoing international roll-out of ZENEO® Midazolam to treat certain epileptic crisis into Australia and New Zealand, with this licensing agreement,” said Patrick Alexandre, CEO of Crossject. “AFT Pharmaceuticals is a particularly well suited partner for us in Australasia because of its strong presence in the region and extensive experience with successful commercial launches. We look forward to collaborating to ensure a strong launch for our exciting innovative needle-free emergency treatment for epileptic crisis.’’

Intramuscular Midazolam is the gold standard to treat patients in the case of certain epileptic seizures¹ that represent a life-threatening situation. The current solutions can be challenging for non-healthcare-professionals to administer during an emergency. There is a clear need for a simple and dependable needle-free way to administer an emergency treatment for epilepsy. The simplicity of use of ZENEO® (see “Intuitive” study²), will afford patients and their caregivers a needle-free injection technology that delivers life-saving medicine in less than 1/10th second.

“We are very pleased to partner with Crossject to bring ZENEO® Midazolam to our core market,” said Dr Hartley Atkinson, CEO of AFT Pharmaceuticals. ‘‘This ground-breaking needle-free system for rapidly and easily administering a life-saving drug to epileptic patients will fulfill an existing need for the treatment of epileptic seizures. Crossject’s ZENEO® technology represents a natural fit with our longstanding commitment to innovation.”

Under the terms of the agreement, AFT will be responsible for all local regulatory and commercial activities. In exchange for the commercial rights, Crossject shall receive: about €0.5m (AUD 0.79m) of premarketing payments from AFT. About €150k (AUD 237k) is due after the signature of the agreement. The remainder consists of development and approval milestones. Crossject will manufacture and sell the product to AFT at a mid-double-digit percentage of AFT’s net selling price to wholesalers, with a minimum floor price per unit. Filing for marketing approval to Australia and New Zealand regulatory authorities is expected a few months after filing in Europe.

Epilepsy is the fourth most common neurological disorder in the world, affecting roughly 1 in 26 people, according to the Epilepsy Foundation. The disorder affects people of all genders, races, ethnic backgrounds and ages. It causes surges of electrical activity in the brain that can cause recurring seizures.

Epilepsy afflicts an estimated 151,000 people in Australia³ and an estimated 50,000 people in New Zealand⁴.

Crossject SA (Euronext:ALCJ; www.crossject.com) is developing and will soon market a portfolio of drugs for use in emergency situations (epilepsy, overdose, allergic shock, severe migraine and asthma attack). With its patented needle-free self-injection system, Crossject aims to become the world leader in self-administered emergency medications. The company has been listed on the Euronext Growth market in Paris since 2014, and benefits from Bpifrance funding.

AFT Pharmaceuticals Limited (ASX: AFP & NZX:AFT) is a specialty pharmaceutical company operating primarily in Australasia, but with product distribution agreements worldwide. The company’s product portfolio includes prescription and over-the-counter medicines to treat a range of conditions, as well as a patented nebulizer.

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¹ Pre-hospital midazolam for benzodiazepine-treated seizures before and after the Rapid Anticonvulsant Medication Prior to Arrival Trial: A national observational cohort study.
² Human factors study of ZENEO® (needle-free autoinjector) and comparison of different user instruction formats.
³ Epilepsy in Australia, how many Australians have epilepsy?
⁴ Epilepsy consumer experience survey 2018.