House dust mites allergenics extract(ALK-Abello A/S)

The trial now progresses into its second part, expected to complete later in 2024. ALK to submit a protocol amendment for Phase 1-2 efficacy trial extension. ALK (ALKB:DC / OMX: ALK B / AKBLF) announced today that it has completed the first part of its phase 1 clinical trial (named ‘ALLIANCE’) for its investigational sublingual immunotherapy (‘SLIT’) tablet for the treatment of peanut allergy. The first part of the trial investigated the safety and tolerability of 14 days treatment with the peanut tablet at different starting doses. For all dose levels, the peanut tablet was shown to be safe and tolerable and with a safety and tolerability profile in accordance with that of the approved SLIT-tablets (ACARIZAX/ODACTRA®, GRAZAX®/GRASTEK®, RAGWIZAX®/RAGWITEK®, ITULAZAX®/ITULATEK®). No serious adverse events and no cases of treatment emergent anaphylaxis were reported. Based on results from part 1, the starting dose for the second part of the study has been selected. This part of the study will evaluate the safety and tolerability of up-dosing to the highest tolerable maintenance dose. The second part will be initiated imminently and is scheduled to complete later in 2024. Furthermore, ALK has decided to amend the ALLIANCE study protocol to include a third part involving approximately 100 additional patients. This part will evaluate safety and efficacy of the peanut SLIT-tablet as assessed by an oral food challenge following a period of maintenance treatment. The implementation of the third part is contingent upon a successful outcome of the second part. The revised protocol is expected soon to be submitted to the relevant authorities. ALK’s Executive Vice President of Research and Development, Henriette Mersebach, says: “We are pleased to report positive progress in our ALLIANCE trial, addressing potentially life-threatening peanut allergy. Encouraged by the initial results for the peanut tablet, we have made a provisional decision to extend the trial into a seamless Phase 1-2 design allowing us to explore the efficacy of the tablet as well. Leveraging our profound R&D expertise, we remain committed to developing valuable new treatment options for people with allergy”. In the USA, peanut allergy affects up to 1.5 million children and adolescents aged 4-17, while in Europe, around 1 million children and adolescents are affected by this potentially life-threatening condition. The disease often presents in early childhood and can last a lifetime. For some of these patients, allergy immunotherapy may become a relevant treatment option with the potential to improve quality of life, both for them and their families. This announcement is not expected to materially change the R&D cost outlook for 2024-25. 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 This information is information that ALK is obliged to make public pursuant to the EU Market Abuse Regulation. About the ALLIANCE trialInitiated in 2022, the ALLIANCE trial was designed to assess the tolerability and safety of an up-dosing regimen with a once-daily peanut SLIT-tablet in adults, adolescents, and children. The trial is a phase I, open-label, dose-escalation, multi-site trial conducted in North America, with approximately 100 participants with peanut allergy confirmed by screening via a double-blind, placebo-controlled food challenge. The first part of the trial aimed at determining the starting dose of the up-dosing regimen and the second part to assess safety and tolerability of the up-dosing regimen as well as gather early data on its biological action. The third part intends to investigate safety and efficacy of selected doses of the peanut SLIT-tablet compared with placebo. The trial marked the formal start of ALK’s clinical development of a novel food allergy treatment which uses the same technology as ALK’s SLIT tablets for respiratory allergies. 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 FM_01_2024UK_18012024

ALK (ALKB:DC / OMX: ALK B / AKBLF) and its Japanese partner Torii Pharmaceutical Co., Ltd. ('Torii') today announced that they have expanded their collaboration and entered into an additional license agreement, granting Torii exclusive rights for Japan to develop, market and distribute ALK's allergy immunotherapy tablet for the treatment of grass pollen allergy (marketed as GRAZAX® in Europe and GRASTEK® in North America). Established in 2011, the partnership with Torii is currently the most important contributor to ALK’s global AIT tablet sales outside Europe. Under the existing license agreements with ALK, Torii currently markets CEDARCURE™, the only approved tablet for the treatment of Japanese cedar pollen induced allergy and MITICURE™ for the treatment of house dust mite induced allergy. Peter Halling, President and CEO at ALK, states: “We are excited about this opportunity to expand our strong Japanese partnership with Torii and increasingly contribute with solutions to the wide-spread burden of allergy in Japan. Given the emerging unmet medical need, we are convinced there is a potential for contemporary and efficacious allergy immunotherapy products targeting grass pollen allergy in Japan.” Under the new agreement, ALK is entitled to receive a milestone payment of EUR 13 million (DKK ~97 million) subject to successful local clinical development over the coming years and regulatory approval. In addition, ALK will receive royalties on future sales and a transfer price for product supply. Torii will be responsible for clinical development, registration, marketing, and sale of the tablet in Japan. ALK will be responsible for manufacturing and product supply and provide R&D support to the local clinical development. Pollen allergies in Japan have surged to unprecedented levels and are currently believed to affect around 40% of the population, primarily driven by Japanese cedar tree pollen. Although Japanese cedar allergy remains the most widespread, there is a rising incidence of other pollen allergies, including those triggered by grass pollen, and Torii has been receiving requests from healthcare professionals and patients to develop an allergen immunotherapy drug for grass pollen allergies. GRAZAX® was the world’s first sublingual allergy immunotherapy tablet, first launched in 2006 and is currently approved in 34 countries across Europe, North America, and the Asia Pacific region. GRAZAX® is approved for treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis in persons aged five to 65 years. Numerous clinical trials have demonstrated the tablet’s safety, efficacy and long-term disease modifying effect in both paediatric and adult patients. This announcement does not change ALK’s financial outlook for 2023. 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 This information is information that ALK is obliged to make public pursuant to the EU Market Abuse Regulation. 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 FM_16_23UK_12122023