HQ Team
November 13, 2024: ALK-Abelló, the Danish pharma company has acquired exclusive rights to Neffy (epinephrine nasal spray) from ARS Pharmaceuticals for an upfront payment of $145 million. This licensing deal allows ALK to market Neffy in Europe and Canada while ARS retains rights in the U.S., Australia, New Zealand, Japan, and China.
The announcement follows the recent approval of Neffy as the first and only nasal spray for treating severe allergic reactions or anaphylaxis by both the U.S. Food and Drug Administration (FDA) and the European Commission earlier this year.
Under the terms of the agreement, ALK will pay up to $320 million in milestone payments along with tiered royalties on net sales. This could lead to a total deal value of approximately $465 million.
ARS will continue to manage the manufacturing and supply of Neffy, ensuring quality control and consistency while allowing ALK to handle marketing and sales in licensed territories. This division of responsibilities helps ARS maintain operational flexibility as it prepares for its U.S. launch
The Danish company plans to launch Neffy in Europe by 2025 and intends to submit a regulatory approval application in Canada by the end of this year. The acquisition comes at a time when traditional treatments like Mylan’s EpiPen face limitations for patients who are needle-averse. ALK’s CEO Peter Halling emphasized that nasal delivery of adrenaline could redefine standards of care in managing anaphylaxis over the next decade. Neffy is positioned as a more user-friendly alternative to injectable products, addressing concerns about delayed treatment associated with auto-injectors.
Analysts predict that Neffy could achieve annual peak sales of approximately $332.8 million in licensed regions, with U.S. sales potentially reaching $585 million by 2030. Richard Lowenthal, co-founder and CEO of ARS Pharmaceuticals, expressed confidence in the partnership with ALK, describing it as ideal due to ALK’s established presence in the allergy field across 46 countries. He noted that this collaboration would enhance access to Neffy for patients needing effective treatment for Type I allergic reactions.
As part of its ongoing strategy, ARS is also planning a Phase IIb trial for evaluating Neffy’s effectiveness in treating acute urticaria flares starting in 2025, further expanding its therapeutic applications.
