RECORDATI LICENSES AN INNOVATIVE EPINEPHRINE NASAL SPRAY IN DEVELOPMENT FOR ANAPHYLAXIS PREVENTION

RECORDATI LICENSES AN INNOVATIVE EPINEPHRINE NASAL SPRAY IN DEVELOPMENT FOR ANAPHYLAXIS PREVENTION

Milan, 21 September, 2020 - Recordati announces the signing of an exclusive license agreement with ARS Pharmaceuticals, a private U.S. company, for the commercialization in the European Union, Iceland, Liechtenstein, Norway, Switzerland, United Kingdom, Russia/CIS, Turkey, Middle East and French-speaking African countries, of ARS-1, an epinephrine nasal spray in late-stage development for the emergency treatment of severe allergic reactions that can lead to anaphylaxis. Under the terms of the agreement an upfront payment is due by Recordati upon signature of the contract and further milestone payments are linked to the regulatory process and commercial performance.

 

Anaphylaxis is a severe, generalized allergic reaction, characterized by life-threatening breathing or cardiovascular problems and usually associated with skin and mucosal changes. The trigger is exogenous and can be associated with food, insect bites or other allergenic substances. ARS-1 is a liquid formulation of epinephrine associated with Intravail, an absorption enhancer, contained in a disposable, mono-dose nasal spray device. This innovative formulation represents a new route of administration compared to existing products, increasing patient compliance and fulfilling an unmet medical need. Easy-to-use and needle-free, this solution may eliminate the anxiety and hesitation associated with using an injection device. With use at the first signs of allergic response, it could provide patients and their families the preventive solution to anaphylactic progression.

 

The marketing authorization application for the 1 mg dose of the product is expected to be filed in the EU by the end of 2020. Furthermore, a dosage strength of 0.65 mg is under development for pediatric patients.

 

“We are very pleased that ARS Pharmaceuticals has granted Recordati the exclusive license to market its innovative product for the prevention of severe allergic reactions in Europe, Russia, the Middle East and other countries”, stated Andrea Recordati CEO. “This effective innovative formulation of a product for the prevention of life-threatening allergic reactions reinforces our Specialty and Primary care pipeline and provides further diversification to our portfolio in an area where medical needs are not fully satisfied.”