Recordati has acquired marketing rights to ARS Pharmaceuticals’ ARS-1 epinephrine nasal spray in the EU, Iceland, Liechtenstein, Norway, Switzerland, the UK, Russia/CIS, Turkey, the Middle East, and francophone African countries, the companies said. ARS will manufacture the nasal spray and supply it to Recordati. The deal includes an upfront payment plus milestones and potential royalties; the amounts were not disclosed.
According to Recordati, the company expects to file an MAA for a 1 mg dose of ARS-1 by the end of 2020, and a 0.65 mg dose for pediatric use is in development. Earlier this year, ARS published results from three Phase 1 studies, EPI 03, EPI 04, and EPI 07, which all demonstrated equivalent exposure for ARS-1 compared to injected epinephrine. In February 2019, the FDA granted Fast Track designation to ARS-1 (also known as “Neffy” in the US) for the treatment of anaphylaxis.
ARS Pharmaceuticals President and CEO Richard Lowenthal commented, “We are thrilled that Recordati has recognized the importance of this new delivery technology for epinephrine that will provide an improved therapy for the millions of people in Europe living with life-threatening allergies. With their strong track-record in specialty medicines, we are excited to work with the team at Recordati, to help deliver a new, easier to dose, pain-free way to treat severe allergic reactions and prevent progression to anaphylaxis. The agreement with Recordati is critical in our continued journey towards Neffy (ARS-1) approval in the United States and worldwide.”
Recordati CEO Andrea Recordati said, “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. 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.”
Read the ARS Pharmaceuticals press release.
Read the Recordati press release.
