Adrenaline

ALK (ALKB:DC / OMX: ALK B) today announced that the National Institute for Health and Care Excellence (NICE) has recommended the use of the company’s tree pollen tablet ITULAZAX® for the treatment in adults. The recommendation allows for patients to gain access to ITULAZAX® through the National Health Service (NHS) systems in England, Wales, and Northern Ireland by making it eligible for general reimbursement. The recommendation of ITULAZAX® is another significant milestone for ALK, marking the second NICE approval of ALK’s sublingual allergy immunotherapy (AIT) products received in 2025. Being the first-ever of their kinds to become widely accessible through the National Health Service (NHS) systems, ACARIZAX® (final approval obtained in March 2025) and ITULAZAX® are now available treatment options to address the significant underutilisation of AIT in the UK compared to other European countries. ALK’s Executive Vice President of Commercial Operations, Søren Niegel, says: “Today’s approval emphasises a remarkable achievement by ALK with now two of our sublingual allergy immunotherapy tablets being recommended by NICE within less than six months. We appreciate the endorsement from a highly respected institute like NICE which improves the treatment accessibility for patients impacted by allergy”. Scientists warn that this year's tree pollen season has started early due to warm weather, leading to higher pollen counts. This is bad news for the approximately 16 million people who are affected by hay fever in the UK, and while many manage symptoms with over-the-counter medicines, the consequences can be more challenging for the 4 million people with moderate to severe tree pollen hay fever. NICE conducts reviews to assess the clinical benefits and cost-effectiveness of healthcare interventions, treatments, and technologies. The institute published a Final Draft Guidance on 21 July 2025, appraising the clinical benefits and cost-effectiveness of ITULAZAX® in the treatment of uncontrolled tree pollen allergy. NICE is expected to publish a Final Guidance in August, after which the NHS systems in England, Wales and Northern Ireland are required to implement ITULAZAX® in the treatment practices. Following the approved applications of ACARIZAX® and ITULAZAX® for adults and adolescents, submissions will also be made to extend the approvals to include children as well as for the grass tablet GRAZAX®. ALK’s current business in the UK mainly focuses on anaphylaxis (treatment of severe allergic reactions) with the adrenaline pen Jext® on the market and the recently approved nasal spray EURneffy® due for launch later this year. AIT tablet sales are currently modest, but ALK expects the combination of its anaphylaxis treatments and the tablets to create long-term synergies in parallel with an expanded infrastructure and as more patients become aware of these treatment options. The NICE approval 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 ALKALK is a global specialty pharmaceutical company focused on allergy and allergic asthma. It markets allergy immunotherapy 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. Attachment InvestorNews_21July25_ITULAZAX recommended by NICE

ALK today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has approved EURneffy® 2 mg in the United Kingdom (UK) for anaphylaxis treatment of adults and children (≥30 kg). The market launch in the UK is expected within the coming months once market access negotiations are completed. EURneffy® (the trade name for neffy® in the EU and the UK) constitutes the first approved adrenaline nasal spray for timely emergency treatment of allergic reactions (anaphylaxis) and holds the potential to transform the lives of patients with severe allergies in the UK. As Europe’s largest anaphylaxis market, UK represents an important market for ALK. 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). Executive Vice President of R&D, Henriette Mersebach (MD), said: “The approval of EURneffy® 2 mg in the UK introduces an alternative and novel adrenaline treatment option for adult and adolescent patients with life-threatening allergies. EURneffy® could improve the lives of people with severe allergic reactions and may facilitate that patients and caregivers continually carry adrenaline wherever they go." The MHRA approval was based on the review of data from the EURneffy® development programme involving over 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. 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. neffy® is developed by US-based ARS Pharmaceuticals, Inc. (“ARS Pharma”). In November 2024, ALK entered into a strategic license agreement with ARS Pharma granting ALK exclusive global rights to commercialise neffy® (including EURneffy® in the 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. 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. The content above comes from the network. if any infringement, please contact us to modify.