According to ARS Pharmaceuticals, Recordati has returned the European marketing rights to ARS-1 epinephrine nasal spray (Neffy) in return for an unspecified amount up front plus future milestone payments connected to European approval and launch and royalties on sales in the EU, UK and other countries covered by the original deal.
In September 2020, Recordati acquired the rights to market the nasal spray in the European Union, the UK, Iceland, Liechtenstein, Norway, Switzerland, Russia/CIS, Turkey, the Middle East, and francophone African countries. ARS submitted an MAA for Neffy to the EMA in November 2020.
Recordati Executive VP Specialty and Primary Care Alberto Martinez said, “We believe ARS-1 will be a differentiated product that will fill an unmet need for patients with Type 1 allergic reactions. This agreement with ARS to re-acquire our rights was made as part of a portfolio review process. We are proud to have contributed to advancing the development of ARS-1 for patients in Europe and wish ARS success as it moves ARS-1 toward approval.”
ARS Pharmaceuticals President and CEO Richard Lowenthal commented, “We are grateful to Recordati for their support to date and, by reacquiring European rights with an anticipated EU regulatory decision later this year, we increase our optionality in pursuing potential strategic transactions or partnerships. Our MAA for Neffy is currently under review by the EMA, and if approved in the EU, we see tremendous potential for commercial success. If approved, this product can be an important treatment option for patients around the world who fear using needle bearing injection devices.”
In the US, the FDA accepted ARS’s NDA for Neffy for the treatment of allergic reactions, including anaphylaxis, in October 2022. ARS says that it plans to submit supplemental applications for a lower dose of the nasal spray for pediatric use following approval in both the US and Europe.
Read the ARS Pharmaceuticals press release.
