SAN DIEGO, Feb. 22, 2023 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions that could lead to anaphylaxis, today announced that the company reached agreement to reacquire commercial rights to neffy, known as ARS-1 in the European region, from Recordati S.p.A. The agreement followed a portfolio review conducted by Recordati aimed at focusing commercial efforts on core strategic therapeutic areas. In 2020, the original license and supply agreement between ARS and Recordati provided ARS with non-dilutive funding for the early clinical development of neffy, while providing Recordati marketing rights to neffy in the European Union, Iceland, Liechtenstein, Norway, Switzerland, United Kingdom, Russia/CIS, Turkey, Middle East and French-speaking African countries. Today, ARS is in a strong position, with approximately $275 million in cash as of year-end 2022, and an anticipated 2023 US launch of neffy, if approved. ARS’ cash is projected to be at least three years of operating runway based on the company’s current operating plan.
“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,” said Richard Lowenthal, president and chief executive officer of ARS Pharmaceuticals. “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.”
“We believe ARS-1 will be a differentiated product that will fill an unmet need for patients with Type I allergic reactions,” said Alberto Martinez, Recordati Executive VP Specialty & Primary Care. “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.”
In connection with the agreement for ARS to reacquire commercial rights to neffy, ARS is obligated to pay Recordati an upfront amount, milestones upon EU approval and commercial launch, and payments (subject to a specified cap) based on commercial sales in the EU, United Kingdom, and certain countries in the Middle East, Africa and Eurasia.
A new drug application (NDA) for neffy 2 mg is currently under review with the U.S. Food and Drug Administration (FDA), as well as a marketing authorization application (MAA) with the European Medicines Agency (EMA). In four primary registration studies of the 2 mg intranasal dose of neffy, all clinical endpoints recommended by regulators were met, and pharmacokinetics were within the range of approved epinephrine injection products. These data included studies in adults, with self-administration and caregiver administration, as well as in children with Type I allergies ≥30 kg (66 lbs). In addition, neffy has been well-tolerated to date with more than 600 individuals receiving at least one dose, and many with repeat administration. The majority of adverse events in clinical trials were mild in nature without any meaningful nasal irritation or pain. A supplemental application for regulatory approval for a neffy 1 mg product for children 15 kg to