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.

 ARS Pharmaceuticals, Inc.  a biopharmaceutical company dedicated to development of products to protect patients from severe allergic reactions that could lead to anaphylaxis, announced 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 ARS Pharma also completed its nitrosamine testing, per the FDA’s draft guidance issued in August 2023, with no measurable levels of nitrosamines detected.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 neffyMAA 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.

“We’re thrilled to be partnering with an innovative company in ARS Pharma to work towards making this innovative needle free adrenaline device for anaphylaxis treatment available for people in Australia and New Zealand who live with severe allergies,” says Danielle Dowell, CSL Seqirus Executive Director of Commercial Operations Asia-Pacific.

“We are encouraged that CSL Seqirus recognizes the importance of making a needle-free epinephrine treatment available to severe allergy patients in Australia and New Zealand, as well as by the robust and compelling neffy product profile and registrational data as we pursue final approval globally,” says Richard Lowenthal, Co-Founder, President and CEO of ARS Pharma. “CSL Seqirus is not only one of the leading fully integrated commercialization partners for vaccines and pharmaceuticals in Australia and New Zealand, but it has a proven track record of successfully commercializing multiple innovative medicines that it has in-licensed for its allergy portfolio over the years.”

ARS Pharma will receive an upfront payment and be eligible for event-driven milestone payments. Following local regulatory approval of neffy, ARS Pharma will be responsible for supplying finished product to CSL Seqirus in exchange for a transfer price.