SAN DIEGO, Oct. 08, 2025 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a commercial-stage biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect patients from allergic reactions that could lead to anaphylaxis, today announced the Opposition Division of the European Patent Office (the “EPO”) upheld the validity of all claims in EP 3678649, which is a patent validated in over 30 European countries directed to nasal spray epinephrine formulatio ...

Core Viewpoint - ARS Pharmaceuticals has received approval from Japanese regulators for neffy, a needle-free epinephrine nasal spray, which addresses a significant need for emergency treatment of anaphylaxis in both adults and children in Japan [1][2] Group 1: Product Approval and Market Entry - The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan has approved neffy in 1 mg and 2 mg doses for emergency treatment of allergic reactions in individuals weighing over 15 kg [1] - Alfresa Holdings, which holds the marketing rights for neffy in Japan, anticipates that the product will be available in the fourth quarter of 2025 [1][3] Group 2: Market Need and Patient Statistics - Approximately 900,000 individuals in Japan are estimated to be affected by food allergies, with the prevalence in children doubling from 2010 to 2019 [2] - A survey conducted in 2025 revealed that only 14% of Japanese patients who experienced anaphylaxis had an epinephrine auto-injector prescription, and only half used it during their most recent episode [2] Group 3: Product Features and Advantages - Neffy offers a compact design with an extended shelf life of 24 months, making it easier for patients and caregivers to carry and administer during emergencies [2] - The product is already commercially available in the U.S. and has received regulatory approvals in Germany and the U.K., with further approvals expected in Canada, Australia, New Zealand, and China by 2026 [4]

$15.7 million in revenue, including $12.8 million in neffy U.S. net product revenue in second quarter of 2025 Growth for neffy in the U.S. driven by increased payor access with additional near-term growth anticipated from national direct-to-consumer (DTC) campaign and pediatric co-promote partnership 93% commercial coverage achieved with streamlined prior authorization process with approval rates at the pharmacy benefit manager (PBM) comparable to overall epinephrine market EURneffyapproved in the United Ki ...

Core Viewpoint - The approval of EURneffy as the first needle-free adrenaline treatment in the U.K. represents a significant advancement for patients with severe allergies, addressing the need for a more accessible emergency treatment option [2][4]. Group 1: Product Overview - EURneffy is an epinephrine nasal spray approved for emergency treatment of allergic reactions, including anaphylaxis, in adults and children over 30 kg [1][5]. - The product is expected to be available in the U.K. by late Q3 2025, with the U.K. being the largest market outside the U.S. for adrenaline auto-injectors [1][4]. Group 2: Company Partnerships and Financials - ARS Pharmaceuticals entered an exclusive licensing agreement with ALK-Abelló A/S in November 2024, granting ALK rights to commercialize neffy outside the U.S. [2][4]. - ARS Pharma received a $145 million upfront payment and is eligible for up to an additional $320 million in milestone payments, along with tiered royalties on net sales in licensed territories [2][4]. Group 3: Market Strategy and Promotion - A co-promotion agreement was initiated between ARS Pharma and ALK in May 2025 to reach nearly 20,000 healthcare providers, particularly targeting pediatricians during the back-to-school season [3]. - ALK successfully launched EURneffy in Germany in late June 2025, with further regulatory approvals expected in Canada, Japan, Australia, and China by the end of 2025 and into 2026 [4].

Neffy Approval and Indication - Neffy (epinephrine nasal spray) has been approved for the emergency treatment of Type I allergic reactions, including anaphylaxis, in adults and children weighing ≥30kg[4, 65] - The available dose strength is a 2 mg nasal spray device[8] - A supplemental regulatory application (sNDA) for a 1 mg dose for children 15 kg to <30 kg is expected to be filed with the FDA in Q3 2024[2, 22] Addressing Unmet Needs and Market Opportunity - Only 10%-20% of patients with active prescriptions use them as indicated, highlighting significant limitations with current treatment options[5] - Approximately 40 million patients have type 1 allergic reactions, with ~20 million diagnosed and under physician care[25] - The US severe allergic reaction market has shown consistent growth, with a +6.5% Compound Annual Growth Rate (CAGR) since 2010 and +12.7% Year-over-Year (YoY) growth in 2023[25] - Market research indicates a 45% reduction in time to use with neffy compared to current devices, suggesting faster administration[30] Clinical Trial Data and Safety - Registrational studies demonstrate comparable pharmacodynamic (PD) surrogates for efficacy and pharmacokinetic (PK) with approved products[19] - In clinical trials, 100% of patients responded to a single dose of neffy within the first 15 minutes, and did not require a second dose of epinephrine per treatment guidelines in an oral food challenge induced anaphylaxis study[41] - The most common adverse events (>2%) with a single dose of neffy were mild nasal discomfort (9.7%) and mild headache (6%)[12, 19] Commercialization and Market Access - A commercial force of 110 sales representatives and area sales managers will target 12,500 allergy specialists and high decile prescribers[38] - The company anticipates at least 80% unrestricted access in the US by mid-2025[62] - A co-pay buy-down program will reduce the patient co-pay to $25 for commercially insured patients[48, 49] Global Expansion and Future Development - Filings by partners in Australia, China, and Japan are expected in 2024, with filings planned in Canada and other regions[22, 62] - Phase 2b trial results for treating acute urticaria exacerbations in CSU patients on antihistamine therapy are expected in 2025[23, 62] - The company has a strong balance sheet of $218.7 million and an expected operating runway of at least 3 years to support US commercialization[62]

Core Insights - ARS Pharmaceuticals has launched neffy, a 1 mg epinephrine nasal spray, now available by prescription in the U.S. for children aged four years and older, addressing the need for needle-free treatment of Type I allergic reactions, including anaphylaxis [1][5][6] Group 1: Product Availability and Features - The neffy nasal spray is designed to be easy to use and portable, making it suitable for children to carry in backpacks or lunchboxes [2] - Human factor studies indicate that 100% of users successfully administered neffy by following instructions, compared to a 35% error rate with injection devices [2] - The product has a shelf life of 24 months and can withstand temperatures up to 122°F (50°C) for three months without compromising quality [2] Group 2: Access and Affordability - ARS Pharmaceuticals offers a co-pay savings program, allowing eligible commercially insured patients to pay no more than $25 for two single-use neffy devices [3] - The cash price for neffy is $199 for two doses, and the Patient Assistance Program provides neffy at no cost for certain uninsured or underinsured individuals [3] - The company is working with major insurance providers to ensure broader access to neffy, aiming to reduce barriers for patients [4] Group 3: Market Context and Community Impact - Approximately 40 million people in the U.S. experience Type I allergic reactions, with 20 million diagnosed with severe reactions in the last three years [15] - Despite the prevalence, only 3.2 million filled their active epinephrine auto-injector prescriptions in 2023, highlighting a significant gap in treatment accessibility [15] - The introduction of neffy is expected to improve the likelihood of timely administration of epinephrine during allergic emergencies, particularly among children [4][15]

Core Viewpoint - ARS Pharmaceuticals has entered into a co-promotion agreement with ALK-Abelló A/S to promote neffy, an epinephrine nasal spray, targeting pediatricians and enhancing access to this needle-free treatment for severe allergic reactions, particularly ahead of the back-to-school season [1][2][3] Company Overview - ARS Pharmaceuticals is focused on empowering at-risk patients and caregivers to protect against severe allergic reactions that could lead to anaphylaxis [1][17] - The company is commercializing neffy, the only approved needle-free treatment for Type I allergic reactions, including anaphylaxis, for patients aged 4 years and older who weigh at least 33 pounds [4][6][17] Partnership Details - The agreement allows ARS Pharma to recognize all U.S. revenue and maintain sole responsibility for U.S. commercialization activities, including marketing and distribution [2][5] - ALK will promote neffy to approximately 9,000 pediatricians, representing about 55% of all community-use epinephrine prescriptions in the U.S. [2][5] - The partnership includes performance-based payments for ALK based on exceeding specific market share thresholds, starting at 30% of net revenue above an initial threshold in the second year [5] Market Strategy - ARS Pharma plans to launch a direct-to-consumer campaign in May 2025, coinciding with the availability of a 1 mg dose for children over four years old [3] - The company anticipates broadening unrestricted commercial access for neffy over the summer, ensuring a smooth prescribing experience for patients and physicians [3] Financial Outlook - ARS Pharma expects its operating expenses to increase by approximately $3 million per quarter starting in Q3 2025, but this will not impact its cash flow for 2025 [3]