ALK Acquires Global Rights to ARS Pharmaceuticals’ Neffy Nasal Spray, Poised for Anaphylaxis Treatment Market Expansion
In a significant move, Denmark-based pharmaceutical company ALK has entered into a strategic license agreement with ARS Pharmaceuticals, Inc. (SPRY), securing exclusive global rights to the innovative Neffy adrenaline (epinephrine) nasal spray. This agreement, excluding the United States, Australia, New Zealand, Japan, and China, positions ALK as a major player in the global anaphylaxis treatment market.
Neffy, a groundbreaking product, has already received approval from the FDA in August 2023 for the emergency treatment of allergic reactions, including life-threatening anaphylaxis, in both adults and pediatric patients. It has also gained approval in Europe, with regulatory approval anticipated in Canada by the end of 2024.
The deal grants ALK exclusive rights for new indications in the licensed territories, allowing them to expand Neffy’s application beyond its initial use. ALK plans to initially focus on introducing Neffy to the European and Canadian markets, which are the world’s second and third-largest markets for adrenaline autoinjectors, respectively. This strategic approach leverages ALK’s existing infrastructure and sales channels in these key regions.
However, the agreement holds potential for expansion beyond these initial markets. ALK sees the Asian and Middle Eastern markets as promising territories for Neffy’s future growth. The company projects that Neffy could generate annual peak sales of up to 3 billion Danish Kroner (approximately $430 million) in the licensed territories, with potential for even higher revenue from new indications like urticaria.
This strategic acquisition has also proven lucrative for ARS Pharmaceuticals. ALK is providing an upfront payment of $145 million (1 billion Danish kroner) to ARS Pharma, with the potential for additional payments of up to $320 million (2.2 billion Danish Kroner) tied to regulatory and commercial milestones over the next 15+ years. ARS Pharma will also receive tiered royalties on future sales of Neffy.
While ALK will handle local market access, marketing, and sales, ARS Pharma will supply finished goods. The first launches are expected to take place in Europe in 2025, following the completion of local market access negotiations.
The market response to this deal has been overwhelmingly positive. William Blair, a prominent financial firm, highlights the impressive 200% surge in ARS Pharmaceuticals’ stock price this year. They believe there is further room for growth, particularly driven by the anticipated strong launch of Neffy, which could exceed current market expectations. Survey results indicate significant demand for Neffy in the near future, with early-stage payer coverage exceeding expectations. This bodes well for a successful launch throughout 2025.
William Blair expects a robust commercial rollout for Neffy, driven by its unique status as an approved and distinct product, potentially leading to blockbuster-level peak sales. As a result, the firm maintains an Outperform rating for ARS Pharmaceuticals stock.
The market has reacted favorably to this news, with SPRY stock rising 4.99% to $17.89 in the premarket session on Monday. This acquisition marks a significant step for ALK and positions the company for considerable growth in the anaphylaxis treatment market. With a strong product like Neffy and a strategic approach to market entry, ALK is poised to become a key player in the global fight against life-threatening allergic reactions.
