EURneffy (adrenaline nasal spray) Approved in the EU as the First and Only Needle-Free Emergency Treatment of Allergic Reactions (anaphylaxis)

Rhea-AI Summary

ARS Pharmaceuticals, Inc. (Nasdaq: SPRY) announced that the European Commission approved EURneffy (adrenaline nasal spray) on August 22, 2024, for emergency treatment of allergic reactions (anaphylaxis). This marks the first needle-free treatment option in the EU for adults and children (≥30 kg) with severe allergies in over 30 years. EURneffy's approval follows FDA approval in the US on August 9, 2024.

The approval was based on extensive clinical data from over 700 study participants and 1,200 administrations. EURneffy offers advantages such as a smaller form factor and longer, less temperature-sensitive shelf-life, potentially increasing the likelihood of patients carrying and administering adrenaline during allergic reactions. ARS Pharma anticipates EURneffy's availability in certain EU Member States by Q4 2024.

Positive

• First needle-free emergency treatment for allergic reactions approved in the EU
• Potential for increased patient compliance due to easier administration and storage
• Extensive clinical data supporting approval (700+ participants, 1,200+ administrations)
• Patent protection until 2039 in Europe
• Anticipated market availability in Q4 2024 in certain EU Member States

Negative

• None.

Insights

Medical Research Analyst

The approval of EURneffy marks a significant milestone in anaphylaxis treatment. As the first needle-free emergency treatment for allergic reactions in the EU, it addresses a critical gap in patient care. The extensive clinical program, involving over 700 participants and 1,200 administrations, demonstrates robust efficacy and safety profiles. Notably, the eight-year data protection and ten-year marketing protection provide ARS Pharmaceuticals with a strong market position. The 2 mg dosage, tested across various conditions, shows versatility in real-world scenarios. This approval could potentially increase adrenaline utilization among at-risk patients, addressing the current underuse of this life-saving medication.

Market Research Analyst

EURneffy's approval opens up a significant market opportunity for ARS Pharmaceuticals. The European severe allergy market is substantial and being the first needle-free option gives ARS a competitive edge. The planned Q4 2024 launch through an established European pharmaceutical partner suggests a strong go-to-market strategy. The longer shelf-life and less temperature sensitivity of EURneffy compared to injectable alternatives could drive market penetration. Additionally, the patent protection until 2039 provides a long runway for market exclusivity. Investors should monitor the initial uptake and reimbursement decisions across EU member states, as these will be key indicators of EURneffy's commercial success and potential impact on ARS Pharmaceuticals' revenue stream.

Financial Analyst

This EU approval, following the recent FDA approval, positions ARS Pharmaceuticals for potential revenue growth. The dual-market access in the US and EU expands the addressable patient population significantly. While specific financial projections aren't provided, the Q4 2024 European launch timeline gives investors a clear horizon for potential revenue impact. The partnership strategy for EU distribution indicates a capital-efficient approach to market entry. Investors should focus on upcoming quarterly reports for insights into launch preparations and any revenue guidance. The long patent protection and market exclusivity periods provide a solid foundation for long-term value creation. However, it's important to monitor the company's cash position and burn rate as they transition from development to commercialization phases.

EURneffy offers adults and children (≥30 kg) in Europe living with severe allergic reactions the first new delivery method for adrenaline in more than 30 years in the EU

European Commission decision follows FDA approval in the United States on August 9, 2024

SAN DIEGO, Aug. 26, 2024 (GLOBE NEWSWIRE) --   ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to the development of products to better protect patients from severe allergic reactions that could lead to anaphylaxis, announced today that the European Commission has approved EURneffy® (adrenaline nasal spray) for the emergency treatment of allergic reactions (anaphylaxis) on August 22, 2024.

“Adrenaline is the only first-line treatment for allergic reactions including anaphylaxis, yet there is significant underutilization of adrenaline due to the limitations of current available therapy,” said Antonella Muraro, MD PhD, Professor of Food Allergy at the University of Padua, and lead author of the European Academy of Allergology and Clinical Immunology (EAACI) treatment guidelines for anaphylaxis, “The approval of EURneffy provides the first needle-free treatment option available in the EU for adults and children (≥30 kg) with severe allergies, many of whom may not carry, or delay use of an injectable adrenaline product.”

“Today’s approval marks an important moment for the severe allergy community in the EU, and the first novel adrenaline delivery method in more than three decades,” said Richard Lowenthal, Co-Founder, President and CEO of ARS Pharma. “EURneffy’s needle-free, smaller form and longer and less temperature-sensitive shelf-life may increase the likelihood that patients will both carry and administer adrenaline, which improves the outcome of allergic reactions.”

The approval of the mixed application for marketing authorization grounded on Article 8(3) of Directive 2001/83/EC by the European Commission was granted following the review of data from one of the most extensive nasal spray development programs in history involving more than 700 study participants and over 1,200 administrations, as well as studies and peer-reviewed literature substituting or supporting certain tests and studies. The pharmacodynamics and pharmacokinetics of 2 mg EURneffy were evaluated across a range of dosing conditions, including single and repeat dosing, self-administration by patients, dosing in pediatrics, and during multiple nasal conditions that can cause congestion and rhinorrhea such as nasal allergen challenge or infectious rhinitis caused by a cold/flu.

EURneffy benefits from an eight-year period of data protection whereby another applicant cannot rely the data submitted as part of the EURneffy marketing authorization application, and a ten-year period of marketing protection during which a generic, hybrid or biosimilar cannot be placed on the market in the EU. The issued composition of matter and method of treatment patents covering EURneffy in Europe expire in 2039.

ARS Pharma anticipates that EURneffy will be made available to patients in certain European Union Member States in Q4 2024 by a pharmaceutical company with an already established commercial footprint in Europe.

EURneffy is the trade name for neffy® (epinephrine nasal spray) in the European Union.

About Type I Allergic Reactions including Anaphylaxis
Type I severe allergic reactions are serious and potentially life-threatening events that can occur within minutes of exposure to an allergen and require immediate treatment with epinephrine, the only approved medication for these reactions in the European Union. While adrenaline autoinjectors have been shown to be highly effective, there are well published limitations that result in many patients and caregivers delaying or not administering treatment in an emergency situation. These limitations include fear of the needle, lack of portability, needle-related safety concerns, lack of reliability, and complexity of the devices. Even if patients or caregivers carry an autoinjector, more than half either delay or do not administer the device when needed in an emergency.

About ARS Pharmaceuticals, Inc.
ARS Pharma is a biopharmaceutical company dedicated to the development of products to better protect patients from severe allergic reactions that could lead to anaphylaxis. The Company is commercializing neffy^® (trade name EURneffy in the EU),, an intranasal epinephrine product in clinical development for patients and their caregivers with Type I allergic reactions including food, medications and insect bites that could lead to life-threatening anaphylaxis. For more information, visit www.ars-pharma.com.

Forward-Looking Statements
Statements in this press release that are not purely historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include but are not limited to: the potential market and demand for EURneffy; the needle-free profile of neffy potentially increasing the likelihood that patients may both carry and administer adrenaline; the expected intellectual property protection; the timelines for commercialization of EURneffy in the European Union; ARS Pharma’s marketing and commercialization strategies, including potential partnerships in foreign jurisdictions; and other statements that are not historical fact. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “anticipate,” “expects,” “potential,” “will,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon ARS Pharma’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation; the ability to obtain and maintain regulatory approval for neffy; potential safety and other complications from neffy; the labelling for neffy in any future indication or patient population, if approved; the scope, progress and expansion of developing and commercializing neffy; the potential for payors to delay, limit or deny coverage for neffy the size and growth of the market therefor and the rate and degree of market acceptance thereof vis-à-vis intramuscular injectable products; ARS Pharma’s ability to protect its intellectual property position; and the impact of government laws and regulations. Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption “Risk Factors” in ARS Pharma’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, filed with the Securities and Exchange Commission (SEC) on August 6, 2024. This and other documents ARS Pharma files with the SEC can also be accessed on ARS Pharma’s website at ir.ars-pharma.com by clicking on the link “Financials & Filings” under the “Investors & Media” tab.

ARS Investor Contact:
Justin Chakma
ARS Pharmaceuticals
justinc@ars-pharma.com

ARS Media Contact:
Christy Curran
Sam Brown Inc.
christycurran@sambrown.com

FAQ

When was EURneffy (adrenaline nasal spray) approved in the EU for SPRY?

EURneffy was approved by the European Commission on August 22, 2024, for the emergency treatment of allergic reactions (anaphylaxis).

What is unique about EURneffy compared to other anaphylaxis treatments for SPRY?

EURneffy is the first and only needle-free emergency treatment for allergic reactions (anaphylaxis) approved in the EU in over 30 years.

When does ARS Pharmaceuticals (SPRY) expect EURneffy to be available in the EU?

ARS Pharmaceuticals anticipates that EURneffy will be available to patients in certain European Union Member States in Q4 2024.

What are the potential advantages of EURneffy for SPRY in treating anaphylaxis?

EURneffy offers a needle-free, smaller form factor with longer and less temperature-sensitive shelf-life, potentially increasing the likelihood of patients carrying and using it during allergic reactions.