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

ALK (ALKB:DC / OMX: ALK B) today announced that it has entered into a strategic license agreement with US-based ARS Pharmaceuticals, Inc. (ARS Pharma, NASDAQ: SPRY). The agreement grants ALK exclusive global rights to the neffy ® adrenaline (epinephrine) nasal spray, with exception of the USA, Australia, New Zealand, Japan and China. The deal delivers on key elements in ALK’s new strategy Allergy+ and supports ALK’s long-term financial ambitions.

• Needle-free, nasal delivery of adrenaline has the potential to become an important treatment option in anaphylaxis
• ALK also gains rights to future indications, including acute urticaria flares (in development)
• ALK to pay USD 145 million in upfront and additional future milestones and sales royalties

neffy ® is the first and only approved needle-free emergency treatment for patients experiencing acute and potentially life-threatening allergic reactions. The European Commission granted EURneffy ® (the trade name for neffy ® in the EU) market authorisation in the EU in August 2024. Furthermore, neffy ® was approved by the US Food and Drug Administration also in August 2024. Submission for regulatory approval in Canada is planned for by the end of 2024.

ALK’s CEO, Peter Halling, said: We are excited about the deal with ARS Pharma. It is an important step in ALK’s strategic efforts to establish leading positions in anaphylaxis, food allergy, and new disease areas such as urticaria, supplementing our core allergy offerings. Emergency treatment of life-threatening allergic reactions has strong scientific and commercial ties to our existing portfolio and prescriber base. We are convinced that neffy ® will transform anaphylaxis, benefitting patients at risk and leading to a significant expansion of the market.

Exclusive rights to new indications
ARS Pharma is also developing its intranasal adrenaline (epinephrine) technology for the treatment of acute flares in patients with chronic urticaria, with plans to begin a Phase IIb clinical trial in 2025. The license agreement gives ALK exclusive rights for any new indications in the licensed territories. This aligns well with ALK’s strategy, as it enables the ALK to take the first steps in addressing new adjacent disease areas.

Expanding market opportunities
ALK will initially focus on bringing neffy ® to the markets in Europe and Canada, the world’s second and third largest adrenaline autoinjector (AAI) markets. In both markets, the product can be added to ALK’s…