A Danish company is spending $145 million upfront for certain rights to the first-ever needle-free adrenaline nasal spray for severe allergic reactions, unlocking sales potential of more than $400 million in these territories.
ALK-Abelló Pharmaceuticals will get exclusive rights to ARS Pharmaceuticals’ anaphylaxis drug neffy in all markets except the US, Australia, New Zealand, Japan and China, according to a Saturday
release
. Further, ARS could get up to $320 million in regulatory and commercial milestones as well as tiered royalties on sales.
In early August, the FDA
greenlit neffy
as the first nasal spray for anaphylaxis with a
Europe approval
following later that month. It is the first needle-free alternative to EpiPens on the market for severe allergic reactions and has a list price of $710 per pack in the US without accounting for potential rebates.
Jefferies analysts said Sunday they see a “sizable role” for neffy in the anaphylaxis market, driven by “market expansion via patient volumes and willingness to administer, as well as a likely premium pricing strategy.” On Monday, William Blair analysts wrote ALK believes the drug could hit more than $400 million in peak sales in the markets it has licensed it in.
The deal also gives ALK exclusive rights to neffy for any new indications in the licensed territories, marking the first time the company is stepping into allergy-adjacent areas. ARS is currently developing intranasal adrenaline for acute flares in patients with chronic urticaria, with plans to start a Phase IIb study next year.
For the Californian company ARS, the agreement offers “a nice royalty stream” and boosts its cash balance “to invest in the ongoing launch of neffy in the United States,” the William Blair analysts said.
Before neffy’s approval, people with severe allergic reactions had to use adrenaline administered through intra-muscular injection. ALK already markets one of these products in the form of its Jext pen but the injection method has limitations that can lead to patients and caregivers delaying or not administering treatment, the company said.
Other advantages that neffy has over standard of care include stability at a wide range of temperatures and a long shelf-life, the Jefferies analysts said.