ARS Pharma Partners with ALK to Launch neffy® At A Global Level

ARS Pharmaceuticals, Inc., a biopharma company focused on supporting at-risk patients facing severe allergic reactions, has announced a licensing agreement with ALK-Abelló A/S. This agreement grants ALK exclusive rights to market neffy®, an epinephrine nasal spray, branded EURneffy® in Europe, a needle-free emergency treatment for severe Type I allergic reactions, including anaphylaxis. The commercialisation is across Europe, Canada, and other regions outside the U.S. ARS Pharmaceuticals retains U.S. rights to neffy and keeps its existing partnerships in Japan, China, Australia, and New Zealand.

Richard Lowenthal, Co-Founder, President, and CEO of ARS Pharma, said in a statement, “ALK is a specialised pharmaceutical company and a global leader in the allergy field, serving millions of allergy patients across 46 countries. As a multi-billion-dollar commercial leader with strong ties to regulators, healthcare practitioners and patients, ALK is the ideal partner to accelerate further and expand the global reach of neffy,”

He also commented, “This collaboration enhances our strategic agreements to ensure that individuals who need neffy can access this innovative, needle-free treatment for Type I allergic reactions, including anaphylaxis. Additionally, the capital from this agreement enables us to focus fully on our ongoing U.S. commercial launch of neffy, with significant operational flexibility. We are excited about Neffy's future and our ability to positively impact the lives of millions, empowering patients and their caregivers to manage allergic reactions with confidence.”

As part of the deal, ARS Pharma will receive $145 million upfront, with the potential for an additional $320 million upon reaching regulatory and sales targets. ARS will manufacture and supply neffy to ALK and is set to receive royalties in the low teens based on sales in the licensed regions.  The FDA approved Neffy in the U.S. in August 2024, and the European Commission granted marketing authorisation for EURneffy in the EU that same month. ARS also plans to submit a regulatory application in Canada by the end of 2024. 

“We are thrilled to partner with ARS Pharma, a company that shares our commitment to advancing transformative allergy solutions for patients. We have closely followed developments with neffy since ARS Pharma first demonstrated that safe, low-dose, injection-like delivery of epinephrine could be achieved through a nasal spray,” said Peter Halling, President and CEO of ALK. 

“We believe that nasal delivery of epinephrine could become an important new standard of care in anaphylaxis management over the next decade, as nasal delivery addresses the hesitation often associated with needle-based options. Neffy offers strong scientific and commercial ties to our existing product portfolio and sales channels, and this licensing agreement is an important step in our strategic efforts to establish leading positions in anaphylaxis, food allergy, and other adjacent disease areas to supplement our core offering in respiratory allergy. We look forward to making this much-needed treatment accessible to patients,” he further stated.

Additionally, ARS is exploring the use of its intranasal epinephrine technology for treating acute symptoms in chronic urticaria and aims to start a Phase 2b clinical trial in early 2025. ALK will also hold exclusive rights to any future indications for neffy in the licensed regions under the agreement.