ARS Pharmaceuticals has signed a licence agreement with ALK-Abelló (ALK), providing exclusive rights to market its neffy (epinephrine nasal spray) outside the US.
Under the terms of the agreement, ALK will commercialise neffy in Europe, Canada, and other territories outside of the US, under the brand name EURneffy.
In exchange, ARS Pharma will receive $145m in upfront payment and is eligible to receive up to $320min regulatory and sales milestone payments, in addition to tiered royalties.
It will retain all rights to neffy in the US without affecting its existing partnerships in Japan, China, Australia and New Zealand and will manufacture and supply neffy to ALK.
ARS Pharma co-founder, president, and CEO Richard Lowenthal said: “This collaboration enhances our strategic agreements to better 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 US 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.”
neffy is an intranasal epinephrine product used in patients with Type I allergic reactions, including food, medications, and insect bites that could lead to life-threatening anaphylaxis.
Earlier this year, the treatment received the US Food and Drug Administration (FDA) approval in the US and the European Commission (CE) marketing authorisation in the EU.
ARS Pharma intends to file for regulatory approval in Canada by the end of this year.
It is also evaluating its intranasal epinephrine technology for the treatment of acute flares in patients with chronic urticaria to begin a Phase 2b clinical study in early 2025.
ALK president and CEO Peter Halling said: “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.
“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.”
