Japanese cedar pollen allergy immunotherapy(Torii Pharmaceutical Co., Ltd.)

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