ARS Pharma Teams Up With ALK-Abelló To Bring neffy® Nasal Epinephrine To More U.S. Pediatricians

ARS Pharmaceuticals, Inc., a biopharmaceutical company focused on empowering patients at risk of severe allergic reactions, has announced a new partnership with ALK-Abelló A/S to co-promote neffy® (epinephrine nasal spray), the only needle-free treatment approved for Type I allergic reactions, including anaphylaxis. This collaboration aims to enhance access to neffy for pediatric patients, specifically targeting up to 9,000 pediatricians, in anticipation of the upcoming back-to-school season. The agreement underscores ARS Pharma's commitment to expanding its reach among key prescribers, particularly those involved in pediatric care.

The four-year agreement grants ARS Pharma the exclusive right to all U.S. revenue and remains responsible for all commercialization activities within the U.S., including marketing, medical affairs, market access, production, distribution, pharmacovigilance, and ensuring the safety and quality of the product. In the first two years of the partnership, neffy will take primary position in the sales efforts of ALK sales representatives, while in the final two years, it will hold a co-primary position. ARS Pharma will compensate ALK for its promotion activities through a quarterly base fee.

Richard Lowenthal, Co-Founder, President, and CEO of ARS Pharma, said in a statement, “As a result of broad coverage from leading pharmaceutical benefit managers and health plans, millions of patients nationwide now have improved access to neffy. This partnership extension with ALK allows us to efficiently reach healthcare professionals who represent about 55% of all community-use epinephrine prescriptions in the United States. By expanding direct promotion with ALK, the global leader in allergy immunotherapy (AIT) with substantial experience in the allergy space, we can ramp up quickly ahead of the peak summer season to ensure neffy is optimally positioned as a needle-free, safe and effective treatment option for children with severe allergic reactions.”

He further continued, “As the second quarter begins, families nationwide are meeting with healthcare providers to explore treatment options that help protect children from allergic reactions ahead of the back-to-school season. Alongside our expanded pediatrician sales initiative, we’re launching a direct-to-consumer campaign in May to coincide with the availability of the 1 mg dose for children over four years who weigh at least 33 pounds. We also anticipate broadening unrestricted commercial access for neffy over the summer, ensuring a smooth prescribing experience for patients and physicians.”

Additionally, ALK-Abelló will be eligible for performance-based payments starting in the second year of the partnership. These payments will be tied to market share milestones for neffy prescriptions written by pediatricians. For example, ALK will earn payments equal to 30% of net revenue beyond an initial market share threshold in year two, which will increase to 50% in years three and four.

Peter Halling, ALK President and CEO, stated, “We are excited about expanding our partnership with ARS Pharma. We firmly believe that this will prove to be a win-win situation for all parties. More children, caregivers, and prescribers in the U.S. get access to an effective and needle-free anaphylaxis treatment, and this partnership complements our existing allergy immunotherapy portfolio.”

As part of the agreement, ARS Pharma retains the option to terminate the partnership in the event of a change of control, among other specified termination rights. The company also expects its operating expenses to rise by approximately \$3 million per quarter starting in the third quarter of 2025, though this will not affect its 2025 cash flow projections.