ALK-Abelló has acquired rights to Neffy adrenaline nasal spray in Europe and Canada, amongst other countries, from ARS Pharmaceuticals for an upfront payment of $145m.
The licensing deal will see American pharma company ARS retain the rights for the needle-free treatment for anaphylaxis in the US, Australia, New Zealand, Japan and China, while Danish allergy immunotherapy specialist ALK will take on remaining global rights, as per a 9 November press release.
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Shares in the Copenhagen-listed company opened 2.6% up at market open on 11 November compared to the pre-announcement market close. ALK has a market cap of $36.8bn.
Neffy became the first and only approved nasal spray medicine to treat severe allergic reactions, also known as anaphylaxis, earlier this year. The US Food and Drug Administration (FDA) approved the spray in August this year, with the European Commission also granting it market authorisation in the same month under the brand name EURneffy.
Under the terms of the deal with ARS, ALK has agreed to pay up to $320m in milestone payments as well as tiered royalties. ARS will continue to develop and manufacture Neffy, whilst ALK will roll out the spray in licensed territories. The Danish pharma company plans to launch Neffy in Europe in 2025, whilst a regulatory approval application in Canada will be sent off by the end of this year.
Anaphylaxis typically occurs when the body’s immune system develops an immediate and unexpected response to a foreign substance, which can come from food, insect stings, or medications. Injectable products, like Mylan’s EpiPen (epinephrine injection), are currently the go-to treatment for patients undergoing an anaphylactic reaction. Despite their efficacy, ALK highlights limitations in auto-injectors, such as delayed treatment in needle-adverse patients. Neffy could offer a simpler and more user-friendly option compared to EpiPen, the latter having its fair share of controversies over the past decade.
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By GlobalDataALK estimates that Neffy could see annual peak sales potential in anaphylaxis of around $332.8m in licensed territories, whilst GlobalData’s Pharma Intelligence Centre forecasts US sales alone of $585m in 2030. Along with global licensing rights, ALK has also gained rights to future indications for the drug – ARS plans to begin a Phase IIb trial evaluating the spray in acute urticaria flares in 2025.
GlobalData is the parent company of Pharmaceutical Technology.
ALK’s CEO Peter Halling said: “While we believe that nasal delivery of adrenaline could become an important new standard of care in anaphylaxis management over the next decade, we also acknowledge that changing long-standing clinical practices may take time. Therefore, we will maintain a portfolio approach to meet the diverse needs of patients and prescribers.”
Mylan’s EpiPen, which generated sales of $442m in 2023, became part of Pfizer’s spin-off company Viatris in 2020. Pfizer has battled supply issues for the drug this year, along with the first approved generic version of the EpiPen product courtesy of Teva Pharmaceuticals.
