ARS Pharma Expands Neffy’s Global Reach With Canada And UK Filings

ARS Pharmaceuticals, Inc. is a biopharmaceutical company majorly focusing on empowering patients and caregivers to manage allergic reactions and prevent anaphylaxis. The firm has filed for regulatory approval of its innovative epinephrine nasal spray, neffy® (2 mg), in Canada and the United Kingdom. The product will be marketed as EURneffy® in this region by its licensing partner, ALK-Abelló A/S (ALK). This follows Neffy’s recent U.S. approval for treating Type I Allergic Reactions, including anaphylaxis, in adults and children weighing 30 kg (66 lbs.) or more.

Subsequently, in November 2024, the company made a licensing deal that licenses ARS Pharma’s neffy to exclusive marketing across Europe, Canada, United Kingdom and other markets outside the United States. Under the terms of this deal, ARS Pharma was paid the initial $145 million and up to the sum of $320 million, depending on the regulatory and sales milestones achieved. Additionally, ARS Pharma will receive tiered royalties in the teens on net sales within the licensed regions while continuing to handle manufacturing and supply operations for ALK.

“Building upon the approval of neffy in the U.S. and Europe for the emergency treatment of severe allergic reactions, we are committed to helping facilitate access to this life-saving treatment worldwide. With submission in Canada and the U.K., ARS Pharma now has approval or has filed for approval in jurisdictions comprising more than 98 per cent of the current world market for epinephrine. We look forward to hearing from the regulatory agencies following their review of the applications,” said Richard Lowenthal, Co-Founder, President and CEO of ARS Pharma. 

ARS Pharma retains exclusive U.S. rights for neffy. It has established partnerships for its commercialization in other regions, including China, Japan, Australia, and New Zealand, through agreements with Pediatrix Therapeutics, Alfresa Pharma, and CSL Seqirus. Beyond allergic reactions, ARS Pharma is expanding the potential of its intranasal epinephrine technology. The company plans to launch a Phase 2b clinical trial in early 2025 to assess its use in treating acute flares in patients with chronic urticaria. The licensing agreement with ALK also grants them exclusive rights to any future indications for neffy in the licensed territories.