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, the company states.

“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,” says ALK’s CEO, Peter Halling.

Neffy

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 authorization 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.

Exclusive rights to new indications

ARS Pharma is also developing its intranasal adrenaline (epinephrine) technologyfor 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.

Financials considerations

The agreement supplements ALK’s financial ambitions and is expected to diversify the long-term revenue growth. ALK estimates that neffy holds a long-term annual peak sales potential in anaphylaxis of up to DKK 3 billion in the licensed territories. There may be substantial upsides to this potential from new indications in e.g. urticaria.

ARS Pharma is entitled to receive an upfront payment of USD 145 million from ALK. Furthermore, ARS Pharma may receive up to USD 320 million related to regulatory and commercial milestones.

Under the agreement, ARS Pharma is entitled to receive an upfront payment of USD 145 million (DKK 1 billion) from ALK. Furthermore, ARS Pharma may receive up to USD 320 million (DKK 2.2 billion) related to regulatory and commercial milestones, potentially over the next 15+ years as well as tiered royalties in the teens on future sales. ARS Pharma will supply finished goods to ALK, while ALK will be responsible for local market access, marketing and sales.