ALK licenses rights to neffy®, the first approved adrenaline nasal spray for emergency treatment of allergic reactions (anaphylaxis)

Core Insights - ALK has entered into a strategic license agreement with ARS Pharmaceuticals for exclusive global rights to the neffy® adrenaline nasal spray, excluding the USA, Australia, New Zealand, Japan, and China, aligning with ALK's Allergy+ strategy and long-term financial goals [1][3][9] Product and Market Potential - neffy® is the first approved needle-free emergency treatment for anaphylaxis, with market authorization granted in the EU and the US in August 2024, and plans for Canadian regulatory submission by the end of 2024 [2][17] - The agreement allows ALK to explore future indications, including acute urticaria flares, with a Phase IIb clinical trial planned for 2025 [4][9] - ALK aims to launch neffy® in Europe and Canada, which are the second and third largest adrenaline autoinjector markets, leveraging existing sales channels [5][7] Financial Implications - ALK will pay an upfront fee of USD 145 million (DKK 1 billion) to ARS Pharma, with potential additional payments of up to USD 320 million (DKK 2.2 billion) based on regulatory and commercial milestones over the next 15+ years [10][11] - The long-term annual peak sales potential for neffy® in anaphylaxis is estimated at up to DKK 3 billion in the licensed territories, with additional upside from new indications [9][12] - The agreement is expected to contribute to revenue growth starting in 2025, with an initially limited impact but projected to be earnings accretive within a few years [12][13] Strategic Alignment - The deal supports ALK's strategy to establish a leading position in anaphylaxis and related disease areas, enhancing its existing portfolio of allergy treatments [3][8] - ALK will continue to market its adrenaline autoinjector Jext® while developing a next-generation autoinjector through its Genesis project [8][9]