ARS Pharmaceuticals has announced the submission of applications seeking the approval of the 2mg epinephrine nasal spray, neffy, in the UK and Canada.
Set to be marketed as ‘EURneffy’ in these regions, the spray is set to be brought to market in collaboration with ALK- Abelló (ALK), a Denmark-based company specialising in allergy treatments.
This move follows a licensing agreement announced by the company last November, granting ALK exclusive commercialisation rights of the spray in the UK, Canada, Europe, and other regions outside the US.
According to the agreement, ARS Pharma received a $145m upfront payment and could receive up to an additional $320m based on regulatory and sales milestones. The company is tasked with the manufacturing and supply of the spray to ALK.
Retaining all rights in the US, ARS Pharma has established licensing partnerships for the spray in China, Japan, Australia, and New Zealand with Pediatrix Therapeutics, Alfresa Pharma, and CSL Seqirus, respectively.
The company is also in the process of expanding the use of its intranasal epinephrine technology.
A Phase IIb trial is set to commence early this year, targeting the treatment of acute flares in individuals suffering from chronic urticaria.
The licensing agreement with ALK includes exclusive rights to any new indications of the technology within the licensed regions.
The spray leverages ‘Intravail' technology, which aids in the absorption of epinephrine into the body by temporarily widening the gaps between nasal cells, the company noted.
ARS Pharma co-founder, president and CEO Richard Lowenthal said: “Building upon the approval of neffy in the US 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 UK, ARS Pharma now has approval or has filed for approval in jurisdictions comprising more than 98% of the current world market for epinephrine. We look forward to hearing from the regulatory agencies following their review of the applications.”
Last August, the US Food and Drug Administration approved neffy for the emergency treatment of Type I allergic reactions.
