Birch pollen allergy vaccine(ALK-Abello A/S)

ALK (ALKB:DC / OMX: ALK B / AKBLF) today announced that the National Institute for Health and Care Excellence (NICE) has recommended the use of ACARIZAX® for the treatment of persistent, moderate to severe house dust mite allergic rhinitis in adults and adolescents. The recommendation paves the way for patients to gain access to ACARIZAX® through the National Health Service (NHS) systems in England, Wales, and Northern Ireland, now making it eligible for general reimbursement. ACARIZAX® is the first sublingual allergy immunotherapy (AIT) product to be assessed and recommended by NICE, and the treatment will be the first of its kind to become widely available through the National Health Service (NHS) systems. The UK is currently one of the few European markets, where ALK’s allergy tablets are authorised without adequate public reimbursement. Additionally, there is a 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 news marks a milestone for ALK. NICE’s methodologies and guidelines are widely regarded as the gold standard, and we are proud to become the first and only company to make sublingual allergy immunotherapy tablets widely accessible in the United Kingdom for the benefit of the many patients whose lives are profoundly impacted by allergy.” Allergic rhinitis disease is a prevalent condition in the UK, affecting 26% of adults. Among these, house dust mite is the most common airborne allergy, affecting approximately half of those living with allergic rhinitis disease – upwards of 5 million people in the UK. Despite a range of symptomatic treatment options, approximately one million people still live with debilitating and uncontrolled symptoms. 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 The institute published a Final Draft Guidance on 30 January 2025, appraising the clinical benefits and cost-effectiveness of ACARIZAX® in the treatment of uncontrolled house dust mite allergy. NICE is expected to publish a Final Guidance in March, after which the NHS systems in England, Wales and Northern Ireland are required to implement ACARIZAX® in the treatment practices. ALK also plans to soon submit a similar application for a NICE review of its sublingual tree tablet, ITULAZAX®. Submissions will also be made to extend the approvals for ACARIZAX® and ITULAZAX® to include children. 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 nasal spray EURneffy® due for launch later this year, pending regulatory approval. 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 is not expected to affect ALK’s revenue growth in 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_30Jan25_ACARIZAX recommended by NICE

ALK (ALKB:DC / OMX: ALK B) today announced that its European regulatory filing for ACARIZAX® (house dust mite sublingual allergy immunotherapy tablet) in young children aged five to 11 has been approved by the health authorities in 21 EU countries via a type II variation procedure. The first market introductions, including in ALK’s largest market, Germany, are expected to follow over the coming months. The data that formed the basis for the approval includes results from the largest-ever paediatric AIT Phase 3 clinical trial, MT-12, which involved 1,458 children in North America and Europe. MT-12 was a randomised, placebo-controlled trial investigating the efficacy and safety of ACARIZAX® in children aged five to 11 with a clinical history of house dust mite-induced allergic rhinitis/conjunctivitis with or without asthma. The trial demonstrated efficacy and safety of the treatment in children, and the results were recently published in the reputable scientific journal, The Lancet Regional Health – Europe. ALK’s Executive Vice President of R&D, Henriette Mersebach (MD), says: “Today, most children living with allergies are only treated with symptom-relieving medications, such as antihistamines or steroids. Despite this, many children still have uncontrolled symptoms and may benefit from effective treatment options that also address the underlying cause of their disease. Allergy induced by house dust mites often begins in early childhood and is associated with an elevated risk of developing into allergic asthma. Today’s approval marks an important step forward for our ability to transform the medical treatment of children with allergies, as well as for ALK’s long-term growth ambitions”. Globally, it is estimated that more than ten million children, aged five to 11, have uncontrolled respiratory allergies and the number is growing. House dust mites are a common cause of allergy and closely linked to asthma. The house dust mite tablet is marketed as ACARIZAX® in Europe and several international markets, as ODACTRA® in the USA, and as MITICURE™ in Japan. Until now, the tablet has been approved for use in young children only in Japan, where the vast majority of patients receiving treatment are children. In Europe, the tablet is now approved for use in patients aged five to 65 diagnosed by clinical history and a positive test of house dust mite sensitisation (skin prick test and/or specific IgE blood test) with persistent moderate to severe house dust mite allergic rhinitis despite use of symptom-relieving medication. In addition, the tablet is approved for house dust mite-induced allergic asthma in patients aged 18-65. A corresponding regulatory review is currently ongoing with the US Food and Drug Administration. Furthermore, a separate regulatory review of ALK’s tree tablet ITULAZAX® is ongoing in Europe and Canada, also for use in children. These reviews are expected to complete in 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 (‘AIT’) treatments and other products and services for people with allergy and allergy doctors. Headquartered in Hørsholm, Denmark, ALK employs around 2,900 people worldwide and is listed on Nasdaq Copenhagen. Find more information at www.alk.net. Attachment FM_20_24UK_12122024