ALK’s house dust mite tablet (ACARIZAX®) now recommended by NICE for use in the UK health system

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 The institute published a Final Draft Guidance on 30 January 2025, appraising the clinical benefits and cost-effectiveness of ACARIZAX® in the treatment of uncontrolled house dust mite allergy.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 ALK
ALK 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.

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