ARS Pharmaceuticals Submits Response for neffy (epinephrine nasal spray) Marketing Authorization Application to EMA’s CHMP and Enters License Agreement with CSL Seqirus for Commercialization of neffy in Australia and New Zealand

CHMP opinion on neffy Marketing Authorization Application anticipated in the second quarter of 2024

Response addresses all issues previously identified by CHMP, and includes results from a repeat dose PK/PD study of neffy under NAC conditions and updated testing concerning nitrosamine levels

Exclusive licensing deal for Australia and New Zealand with CSL Seqirus; CSL Seqirus will be responsible for applying for regulatory approval, reimbursement and commercialization of neffy. ARS Pharmaceuticals will be responsible for manufacturing and product supply.

SAN DIEGO, April 30, 2024 (GLOBE NEWSWIRE) --  ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to development of products to protect patients from severe allergic reactions that could lead to anaphylaxis, announced today that it has submitted its Day 180 response to the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for its Marketing Authorization Application (MAA) for neffy (epinephrine nasal spray), an investigational new drug to be indicated for the treatment of Type I allergic reactions including anaphylaxis.

The submission follows receipt of Day 180 comments in the fourth quarter of 2023 that requested completion of a repeat dose study of neffy under nasal allergen challenge (NAC) conditions, and completion of updated nitrosamine testing.

In February 2024, ARS Pharma announced the completion of its clinical study assessing repeat doses of neffy in patients with seasonal allergic rhinitis under nasal allergen challenge conditions. ARS Pharma also completed its nitrosamine testing, per the FDA’s draft guidance issued in August 2023, with no measurable levels of nitrosamines detected. Based on the timetable included in the Day 180 comments, ARS Pharma expects CHMP to issue its opinion on the neffy MAA in the second quarter of 2024.

In parallel, ARS Pharma executed an exclusive license and distribution agreement for Australia and New Zealand with CSL Seqirus, a subsidiary of CSL Limited (ASX: CSL). CSL Limited is the largest Australian pharmaceutical company by market capitalization. Under the terms of the agreement, CSL Seqirus will apply for regulatory and pricing and reimbursement approvals, and will be responsible for commercializing neffy across Australia and New Zealand.