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WKN: A3DHX9 | ISIN: DK0061802139 | Ticker-Symbol: 4AJ0
Tradegate
11.06.26 | 09:26
35,840 Euro
+0,50 % +0,180
Branche
Pharma
Aktienmarkt
STOXX Europe 600
1-Jahres-Chart
ALK-ABELLO A/S Chart 1 Jahr
5-Tage-Chart
ALK-ABELLO A/S 5-Tage-Chart
RealtimeGeldBriefZeit
35,98036,08012:23
36,02036,06012:23
GlobeNewswire (Europe)
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ALK Abello: Anaphylaxis management is falling short in 2026 - EAACI data suggest EURneffy, the only needle-free nasal adrenaline spray, could help close the gap

  • Over half (54%) of adults at risk of anaphylaxis admit they have been without their adrenaline auto-injector (AAI) when needed-and nearly 40% do not carry one regularly (n=1,238).1
  • HCP survey data suggests only around half of patients consistently carry their prescribed AAI, with adherence perceived to be lowest among adolescents.2
  • EURneffy, the only needle-free nasal adrenaline spray, was strongly and consistently preferred over AAIs by patients across four countries in a discrete choice experiment.1
  • In a simulated-use study, participants said they would find EURneffy significantly easier to use and would act earlier than with an AAI.3

New scientific data reveal serious shortcomings in the real-world management of anaphylaxis, with findings from two multi-country surveys suggesting that EURneffy-the first and only approved needle-free adrenaline-based product-may help address some of the practical and psychological challenges that limit effective emergency treatment in daily life.1,2 The data generated by ALK were presented at the 2026 European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress in Istanbul, Turkey.

In a cross-sectional survey involving 1,238 adults at risk of severe anaphylaxis across Canada, France, Germany and the UK, nearly 40% said they did not carry their AAI regularly, more than half (54%) had been without one when it was needed, and around one in five (20%) never filled their prescription.1 Fear of needles or uncertainty during reactions were frequently cited reasons.1

Using a discrete choice experiment, participants strongly and consistently preferred EURneffyover AAIs across all four countries.1 This preference was particularly pronounced among participants infrequently carrying their AAI or those not filling their prescription for an AAI.1 The longer shelf life associated with EURneffy was valued positively, with device size and weight having limited impact on patient preference.1

- It's striking that in 2026, we are still far from optimal anaphylaxis management, and patients are being left vulnerable as a result," said Professor Margitta Worm, Division of Allergy and Immunology, Charité - Universitätsmedizin Berlin, Berlin, Germany. "These findings highlight a real opportunity to re-evaluate emergency treatment options and explore whether needle-free alternatives can improve preparedness, confidence and adherence in real-world settings..

A complementary cross-sectional survey of 122 healthcare professionals across the same four countries demonstrated that clinicians estimated that only around half of patients consistently carry their prescribed AAI, with adherence thought to be the lowest among adolescents.2 The most cited barriers were predominantly behavioural and included forgetfulness, low perceived risk, difficulty recognising symptoms, and hesitation to act.2 Healthcare professionals also reported that approximately one-third of patients never or only sometimes use their adrenaline auto-injector in an emergency, and 40% fail to seek emergency care afterwards. Survey findings identified poor adherence, user hesitation and ineffective training as key unmet needs.2

When asked to compare devices, healthcare professionals rated EURneffy nasal adrenaline spray more favourably than AAIs for real-world attributes, including portability, adherence, safety, shelf life and temperature stability, while AAIs retained a higher perceived efficacy, likely due to longer clinical experience with AAIs.2

Four sub-analyses from a randomised crossover study in participants evaluating the trainer device of EURneffy vs AAIs further suggest that EURneffy may reduce psychological and behavioural barriers to timely adrenaline administration.3-6 EURneffy was rated as significantly easier to use than an AAI (93% vs 70%), with greater confidence in correct administration, including in emergency situations.5 EURneffy was also associated with lower anticipatory anxiety, reduced concern about pain or self-injury, and a higher overall willingness to use alongside a lower perceived lifestyle burden and greater ease of integration into daily life.4,6Participants indicated they would administer EURneffy nasal adrenaline at significantly earlier symptom levels than an AAI (median level 3 vs 4, p < 0.001), with 55% saying they would wait until level 4 or 5 before using an AAI, and 3% reporting they would never use one.3

- The consistency of these data are compelling," said Dr. Judit Nyirady, Senior VP, Global Chief Medical Office, ALK. "Across children, adults, caregivers, and healthcare professionals, as well as across multiple countries and studies, the same picture emerges: too many people are still not carrying or using their adrenaline when they need it. EURneffy was developed to meet patients where they are. These data reinforce ALK's commitment to ensuring that everyone at risk of anaphylaxis has a treatment they will actually carry and use."

For further information, please contact:

Media: Maiken Riise Andersen, tel. +45 5054 1434
Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525

About EURneffy
EURneffyis the first and only needle-free adrenaline-based product approved for the emergency treatment of anaphylaxis in adults and children.7 EURneffyis well absorbed through the nose and distributed quickly into body tissues, offering a portable, pocket-sized alternative to injectable forms of adrenaline for treating severe allergic reactions.7,8 EURneffyhas a total shelf life of 30 months (2 mg) and 24 months (1 mg), no special storage requirements and freezing does not affect its shelf life.7,9 Upon activation, EURneffynasal spray delivers a full, single dose of adrenaline, without the need for priming.7 It is recommended that two EURneffy devices are carried to treat a potentially life-threatening emergency in case a second dose is required.7

In the European Union, EURneffy2 mg is approved for the emergency treatment of anaphylaxis in adults and children who weigh = 30kg, and EURneffy1 mg is approved for the emergency treatment of anaphylaxis in children aged 4 and older who weigh from 15 kg to less than 30 kg.7,10 EURneffy2 mg has also been approved in the UK.11 In the United States, Japan, China, Australia and Canada EURneffy2 mg is approved under the brand name neffy2 mg.12-16 In the US and Australia, neffy 1 mg has also been approved for children who weigh 15-30 kg (with an age restriction of 4 years and older in Australia) and in Japan, neffy 1 mg and 2 mg are approved for the emergency treatment of severe allergic reactions (anaphylaxis) in adults and children who weigh =15 kg.9,12

About the patient survey1
The patient survey was a cross-sectional survey conducted among 1,238 adults at risk of severe allergic reactions across Canada, France, Germany, and the UK, recruited via a validated online research platform. All participants self-reported a diagnosis of anaphylaxis, and the survey captured demographics, allergy reaction experience, and adherence to AAIs. A discrete choice experiment quantified patient preferences across treatment attributes including mode of administration, shelf life, temperature stability, cost, device size and weight.

About the healthcare professional survey2
The HCP survey was a cross-sectional survey of 122 healthcare professionals across Canada, France, Germany, and the UK, including general practitioners (35), emergency physicians (17), allergists (16), paediatricians (14), nurses (9), pharmacists (5), and other specialists. All participants prescribed AAIs and were recruited via a validated online platform. The survey assessed prescribing patterns, training and follow-up practices, perceived patient barriers, and comparative views of EURneffyand AAIs.

About the randomised cross-over study3-6
The study included 90 participants that evaluated trainer devices of EURneffy versus an AAI: 60 with severe allergy who had an AAI or cared for someone who did, and 30 completely new to AAIs and severe allergy. None of the participants had prior experience with EURneffy. All participants either used (n=60) or watched someone else use (n=30) trainer versions of both devices (no needle in the AAI device or medicine in either device), and viewed the official instructional videos and summarising information about shelf life, storage conditions, temperature restrictions and how to dispose of both devices, before completing a set of questionnaires using expert-driven rating scales regarding ease of use, willingness to use, lifestyle impact and to determine the earliest symptom level at which they would act (across five escalating severity levels). The analysis of how quickly participants would act included 60 participants from the study: 30 adults (20 with known severe allergy) and 30 caregivers (20 caring for children with known severe allergy).

About anaphylaxis
Anaphylaxis is the most severe form of allergic reaction, characterised by the acute onset of symptoms involving different organ systems, that can occur within minutes of exposure to an allergen, such as insect stings or bites, foods or medicinal products.17 It is a serious and potentially life-threatening event requiring immediate medical treatment that can affect babies, children, adults and the elderly.18,19 Globally, the incidence of anaphylaxis is estimated to range from 50 to 112 cases per 100,000 per year, with rates varying more widely in children, from 1 to 761 cases per 100,000 per year.20,21 It is reported that children and adolescents face the highest incidence of anaphylaxis22-

Adrenaline is universally recognised as the first-line, life-saving treatment for anaphylaxis, with endorsement across major international guidelines.17,18,23,24 Prompt administration is critical to patient outcomes, as delays in treatment are associated with increased morbidity and mortality.25,26 Despite adrenaline's well-established role in anaphylaxis management, AAI use in practice frequently fall short of guideline recommendations.27 Research shows that approximately half of those living with a severe allergy did not administer their AAI when needed in an emergency, and nearly half of those at risk of anaphylaxis do not regularly carry their AAI- 27,28

About ALK
ALK is a global specialty pharmaceutical company focused on allergy. ALK's activities cover the entire value chain of developing, sourcing, producing, and marketing a diversified portfolio of products for diagnosing and treating respiratory allergies and severe allergic reactions (anaphylaxis) in both children and adults. Headquartered in Denmark, ALK employs around 2,700 people worldwide and is listed on Nasdaq Copenhagen (Nasdaq: ALK B). Visit us at www.alk.net-

Forward-looking statements
This announcement contains forward-looking statements, including forecasts of future revenue and operating profit as well as expected business-related events. Such statements are naturally subject to risks and uncertainties as various factors, some of which are beyond the control of ALK, may cause actual results and performance to differ materially from the forecasts made in this announcement. Such factors include, but are not limited to, general economic and business-related conditions, including legal issues, uncertainty relating to demand, pricing, reimbursement rules, regulatory approvals, partners' plans and forecasts, fluctuations in exchange rates, competitive factors, and reliance on suppliers. Additional factors include the risks associated with the sourcing and manufacturing of ALK's products. ALK undertakes no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law.

References

1. Worm M, Fox A, Ben-Shoshan M, et al. Patient Preferences for Nasal Adrenaline Spray versus Adrenaline Auto-Injectors in Anaphylaxis: A Multi-Country Discrete Choice
Experiment. Presentation at the European Academy of Allergy and Clinical Immunology (EAACI) 2026; 12-15 June 2026; Istanbul, Turkey. Abstract 001368.
2. Fox A, Worm M, Pouessel G, et al. Healthcare Professionals' Perspectives on Anaphylaxis
Management: A Multi-Country Survey comparing Adrenaline Auto
Injectors and Nasal Adrenaline Sprays. Presentation at the European Academy of Allergy and Clinical Immunology (EAACI) 2026; 12-15 June 2026; Istanbul, Turkey. Abstract 001283.
3. Mack D, Ewan P, Lacquiere S, et al. Nasal Adrenaline Spray vs Adrenaline Auto-Injectors: When Will People Act? Presentation at the European Academy of Allergy and Clinical Immunology (EAACI) 2026; 12-15 June 2026; Istanbul, Turkey. Abstract 000893.
4. Mack D, Ewan P, Lacquiere S, et al. Intranasal Adrenaline Associated with Lower Administration-Related Anxiety and Higher Willingness-to-Use vs. Adrenaline Auto-Injectors. Presentation at the European Academy of Allergy and Clinical Immunology (EAACI) 2026; 12-15 June 2026; Istanbul, Turkey. Abstract 000889.
5. Mack D, Ewan P, Lacquiere S, et al. Comparative Ease-of-Use Assessment of a Nasal Adrenaline Spray with an Adrenaline Auto-Injectors in Children, Adults and Caregivers. Presentation at the European Academy of Allergy and Clinical Immunology (EAACI) 2026; 12-15 June 2026; Istanbul, Turkey. Abstract 000890.
6. Mack D, Ewan P, Lacquiere S, et al. Patient Perceived Lifestyle Burden with a Nasal Adrenaline Spray vs an Adrenaline Auto-Injector. Presentation at the European Academy of Allergy and Clinical Immunology (EAACI) 2026; 12-15 June 2026; Istanbul, Turkey. Abstract 000891.
7. EURneffySummary of Product Characteristics [online]. Available from: https://www.ema.europa.eu/en/documents/product-information/eurneffy-epar-product-information_en.pdf [Last accessed: May 2026].
8. Casale TB, Ellis AK, Nowak-Wegrzyn A, et al. Pharmacokinetics/pharmacodynamics of epinephrine after single and repeat administration of neffy, EpiPen, and manual intramuscular injection. J Allergy Clin Immunol. 2023;152(6):1587-1596.
9. ARS Pharmaceuticals. ARS Pharmaceuticals Announces FDA Approval of neffy 1 mg (epinephrine nasal spray) for Type I Allergic Reactions, Including Anaphylaxis, in Pediatric Patients Weighing 15 to < 30 Kilograms [online] March 2025. Available from:
https://ir.ars-pharma.com/news-releases/news-release-details/ars-pharmaceuticals-announces-fda-approval-neffyr-1-mg [Last accessed: May 2026].
10. ALK. EURneffy 1 mg approved across the EU as the first and only needle-free adrenaline treatment for young children (=15 kg) at risk of anaphylaxis. Available at: https://ir.alk-abello.com/news-releases/news-release-details/eurneffy-1-mg-approved-across-eu-first-and-only-needle-free [Last accessed: May 2026].
11. ARS Pharmaceuticals. EURneffy (adrenaline nasal spray) Approved in the U.K. as the First and Only Needle-Free Emergency Treatment of Allergic Reactions (anaphylaxis). Available from: https://ir.ars-pharma.com/news-releases/news-release-details/eurneffyr-adrenaline-nasal-spray-approved-uk-first-and-only [Last accessed: May 2026].
12. ARS Pharmaceuticals. neffy (epinephrine nasal spray) Approved in Japan as the First and Only Needle-Free Emergency Treatment of Allergic Reactions (anaphylaxis) [online] September 2025. Available from: https://ir.ars-pharma.com/news-releases/news-release-details/neffyr-epinephrine-nasal-spray-approved-japan-first-and-only [Last accessed: May 2026].
13. ARS Pharmaceuticals. neffy (epinephrine nasal spray) Approved in China as the First and Only Community Use Epinephrine Product for the Treatment of Allergic Reactions (anaphylaxis) [online] December 2025. Available from: https://ir.ars-pharma.com/news-releases/news-release-details/neffyr-epinephrine-nasal-spray-approved-china-first-and-only [Last accessed: May 2026].
14. ALK. neffy approved as the first needle-free anaphylaxis treatment of adults and children in Canada. Available from: https://www.globenewswire.com/news-release/2026/04/15/3274254/0/en/neffy-approved-as-the-first-needle-free-anaphylaxis-treatment-of-adults-and-children-in-Canada.html [Last accessed: May 2026].
15. ARS Pharmaceuticals. ARS Pharmaceuticals Receives FDA Approval of neffy (epinephrine nasal spray), the First and Only Needle-Free Treatment for Type I Allergic Reactions, Including Anaphylaxis. Available from: https://ir.ars-pharma.com/news-releases/news-release-details/ars-pharmaceuticals-receives-fda-approval-neffyr-epinephrine/ [Last accessed: May 2026]
16. TGA. NEFFY adrenaline (epinephrine) 2 mg nasal spray vial (470025). Available at: https://www.tga.gov.au/resources/artg/470025 [Last accessed: May 2026].
17. Muraro A, Worm M, Alviani C, et al. EAACI guidelines: Anaphylaxis (2021 update). Allergy. 2022;77(2):357-377.
18. Cardona V, Ansotegui IJ, Ebisawa M, et al. World allergy organization anaphylaxis guidance 2020. World Allergy Organ J. 2020;13(10):100472.
19. Lieberman P, Nicklas RA, Oppenheimer J, et al. The diagnosis and management of anaphylaxis practice parameter: 2010 update. J Allergy Clin Immunol. 2010;126(3):477-480 e471-442.
20. Cardona V. Overview of allergic disease: Anaphylaxis - WAO White Book on Allergy 2026 - 2.11. World Allergy Organ J. 2026;19(3):101338.
21. Wang Y, Allen KJ, Suaini NHA, et al. The global incidence and prevalence of anaphylaxis in children in the general population: A systematic review. Allergy. 2019;74(6):1063-1080.
22. Kim JH, Ha EK, Shin J, et al. National trends in the prevalence and recurrence of anaphylaxis across all ages: The role of neighborhood deprivation and comorbidity (2002-2019). World Allergy Organ J. 2024;17(12):101005.
23. Dribin TE, Muraro A, Camargo CA, Jr., et al. Anaphylaxis definition, overview, and clinical support tool: 2024 consensus report-a GA(2)LEN project. J Allergy Clin Immunol. 2025;156(2):406-417 e406.
24. Golden DBK, Wang J, Waserman S, et al. Anaphylaxis: A 2023 practice parameter update. Ann Allergy Asthma Immunol. 2024;132(2):124-176.
25. Lieberman JA, Oppenheimer J, Hernandez-Trujillo VP, et al. Innovations in the treatment of anaphylaxis: A review of recent data. Ann Allergy Asthma Immunol. 2023;131(2):185-193 e110.
26. Shaker MS, Wallace DV, Golden DBK, et al. Anaphylaxis-a 2020 practice parameter update, systematic review, and Grading of Recommendations, Assessment, Development and Evaluation (GRADE) analysis. J Allergy Clin Immunol. 2020;145(4):1082-1123.
27. Warren CM, Zaslavsky JM, Kan K, et al. Epinephrine auto-injector carriage and use practices among US children, adolescents, and adults. Ann Allergy Asthma Immunol. 2018;121(4):479-489 e472.
28. Curtis C, Stukus D, Scherzer R. Epinephrine preparedness in pediatric patients with food allergy: an ideal time for change. Ann Allergy Asthma Immunol. 2014;112(6):560-562.


© 2026 GlobeNewswire (Europe)
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