ARS Pharmaceuticals Partners with ALK to Commercialize neffy® Internationally

ARS Pharmaceuticals, Inc., a biopharmaceutical company focused on protecting patients at risk of severe allergic reactions, has announced a licensing agreement with ALK-Abelló A/S (ALK). This partnership grants ALK exclusive rights to commercialize neffy® (epinephrine nasal spray), known as EURneffy® in Europe, outside the United States, specifically in Europe, Canada, and other regions. neffy is the first needle-free emergency treatment for Type I allergic reactions, including anaphylaxis. ARS Pharma retains the rights to neffy within the U.S. and maintains its current partnerships in Japan, China, Australia, and New Zealand.

The agreement entails an upfront cash payment of $145 million to ARS Pharma, with potential additional payments totaling up to $320 million based on regulatory and sales milestones. Furthermore, ARS Pharma will receive double-digit royalties on net sales in the licensed territories. ARS Pharma will be responsible for manufacturing and supplying neffy to ALK.

Richard Lowenthal, Co-Founder, President, and CEO of ARS Pharma, expressed enthusiasm about the collaboration, citing ALK's expertise and global presence in the allergy field. He highlighted that this partnership aligns with ARS Pharma's strategic objectives, ensuring broader access to neffy and enabling the company to concentrate on the U.S. commercial launch. Lowenthal emphasized the potential of neffy to significantly improve the management of allergic reactions, empowering patients and their caregivers.

Peter Halling, President and CEO of ALK, shared similar sentiments, noting the transformative potential of neffy in the field of allergy treatment. He acknowledged the innovative approach of delivering epinephrine through a nasal spray, which could address the common hesitation associated with needle-based treatments. Halling emphasized ALK's commitment to establishing a leading position in anaphylaxis and related areas, complementing their core offerings in respiratory allergies.

In August 2024, neffy received approval from the U.S. Food and Drug Administration, followed by marketing authorization from the European Commission for EURneffy. ARS Pharma plans to seek regulatory approval in Canada by the end of 2024. Additionally, the company is exploring the use of its intranasal epinephrine technology for treating acute flares in chronic urticaria, with a Phase 2b clinical trial set to commence in early 2025. The agreement with ALK also includes exclusive rights for any new indications in the licensed territories.

neffy® is designed for patients experiencing Type I allergic reactions, such as those triggered by food, medications, and insect bites, which can lead to life-threatening anaphylaxis. Its needle-free application offers a significant advantage, addressing concerns associated with traditional epinephrine autoinjectors, including needle fear, portability issues, and the complexity of use. Despite the efficacy of epinephrine autoinjectors, these factors have led to delays or avoidance in administration during emergencies.

ARS Pharmaceuticals, Inc. is dedicated to improving the safety and well-being of at-risk patients by providing innovative solutions for severe allergic reactions. The licensing agreement with ALK represents a significant step in expanding the availability of neffy globally, potentially transforming the standard of care for anaphylaxis management. With this partnership, ARS Pharma aims to enhance the quality of life for millions of patients, ensuring they have access to timely and effective treatment options.