ARS Pharmaceuticals Files for Approval of neffy® in Canada and the United Kingdom on Behalf of Licensing Partner ALK-Abelló A/S

Core Viewpoint - ARS Pharmaceuticals has filed for approval of neffy (epinephrine nasal spray) 2 mg in Canada and the UK, expanding its market presence after recent approval in the U.S. for treating Type I allergic reactions, including anaphylaxis [1][2] Group 1: Product and Market Expansion - neffy will be marketed as EURneffy in Canada and the UK, representing significant markets within the ALK portfolio [1] - The company has now filed for approval in jurisdictions covering over 98% of the global epinephrine market [2] - ARS Pharma retains U.S. rights for neffy and has licensing partnerships in China, Japan, Australia, and New Zealand [3] Group 2: Licensing Agreement and Financials - Under the licensing agreement with ALK, ARS Pharma received an upfront payment of $145 million and can earn up to an additional$320 million in regulatory and sales milestones, along with tiered royalties in the teens on net sales [2] - The agreement grants ALK exclusive rights to commercialize neffy in Europe, Canada, the UK, and other regions outside the U.S. [1][2] Group 3: Clinical Development - ARS Pharma is evaluating its intranasal epinephrine technology for treating acute flares in chronic urticaria, with plans for a Phase 2b clinical trial in early 2025 [4] - The licensing agreement with ALK includes exclusive rights for any new indications in the licensed territories [4] Group 4: Product Information - neffy is indicated for emergency treatment of Type I allergic reactions, including anaphylaxis, in patients weighing 30 kg or greater [5][14] - The product aims to address limitations of traditional epinephrine autoinjectors, which are often not carried or used in emergencies [13]