ALK (ALKB:DC / OMX: ALK B) today announced the first market launch of EURneffy® 2 mg (the trade name for neffy® in the EU) in Germany. The launch of this first ever adrenaline nasal spray for timely emergency treatment of anaphylaxis represents a significant milestone for adults and children (≥30 kg) experiencing potentially life-threatening allergic reactions.
With an intuitive, needle-free design, EURneffy® can help more people confidently use adrenaline when it matters most, supporting fast, reliable emergency treatment and ultimately helping improve the chances of successful outcomes and save lives. EURneffy® offers a longer shelf life (30 months) and superior temperature stability compared to existing adrenaline auto-injectors (AAIs).
ALK's Senior Vice President of Commercial Operations in Europe, Flora Beiche-Scholz, said:
"Physicians in Germany can now – as the first physicians in Europe – prescribe EURneffy® as an easy-to-bring, user-friendly adrenaline treatment option for patients with life-threatening allergies. With EURneffy®, we aspire to improve the lives of people with severe allergic reactions and facilitate that patients and caregivers consistently carry emergency medication."
The EU approval was based on the review of data from the EURneffy® development programme involving more than 700 participants. No serious adverse events were reported in clinical studies with EURneffy®. The extensive clinical pharmacological data of EURneffy® 2 mg was comparable to AAIs, with the pharmacodynamics and pharmacokinetics evaluated across a range of dosing conditions. EURneffy® with a 1 mg dosage for patients weighing 15-30 kg is currently undergoing an EU regulatory review process which is expected to complete in 2026.
In Europe, anaphylaxis occurs in up to eight out of every 100,000 people each year, and one in 300 people experiences it at some point in their lives. In emergency situations, uncertainty and hesitation with larger auto-injectors are apparent among those at risk.
In November 2024, ALK entered into a strategic license agreement with ARS Pharmaceuticals, Inc. granting ALK exclusive global rights to commercialise neffy® (including EURneffy® in EU) with exception of the USA, Australia, New Zealand, Japan, and China. In May 2025, the partnership was extended to include a co-promotion agreement in the USA.
The market launch does not affect ALK’s financial guidance for 2025.
ALK-Abelló A/S
For further information please contact:
Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525
Media: Maiken Riise Andersen, tel. +45 5054 1434
About ALK
ALK is a global specialty pharmaceutical company focused on allergy and allergic asthma. ALK manufactures and markets allergy immunotherapy (‘AIT’) treatments and other products and services for people with allergy and allergy doctors. Headquartered in Hørsholm, Denmark, ALK employs around 2,800 people worldwide and is listed on Nasdaq Copenhagen. Find more information at www.alk.net.
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