ARS Pharmaceuticals Announces EURneffy (adrenaline nasal spray) Recommended for Approval by CHMP for Emergency Treatment of Allergic Reactions (anaphylaxis)
ARS Pharmaceuticals announced that the Committee for Medicinal Products for Human Use (CHMP) recommended the approval of EURneffy (adrenaline nasal spray) for emergency treatment of allergic reactions, including anaphylaxis, in the European Union. This decision marks EURneffy as potentially the first and only needle-free adrenaline option in Europe. The positive opinion is based on extensive data, including studies involving over 700 participants and 1,200 administrations, demonstrating its efficacy and safety. The European Commission is expected to grant formal marketing authorization in Q3 2024, with availability anticipated in Q4 2024. The U.S. FDA is reviewing the same data, with a decision expected by October 2, 2024.
- CHMP recommended approval of EURneffy as the first needle-free adrenaline option in Europe.
- Data supporting approval includes studies with over 700 participants and 1,200 administrations.
- Marketing authorization in the EU expected in Q3 2024, with product availability by Q4 2024.
- FDA is reviewing the application, with an expected decision by October 2, 2024.
- None.
Insights
The positive recommendation for EURneffy by the CHMP signifies a groundbreaking advancement in the treatment of anaphylaxis, especially because it's needle-free. This innovation can potentially revolutionize how severe allergic reactions are managed, improving patient compliance and outcomes. The convenience and reduced anxiety from using a nasal spray, compared to an injection, could enhance the likelihood of patients carrying and administering the medication promptly during emergencies.
The extensive data package, involving over 700 participants and more than 1,200 administrations, underscores the rigorous testing and validation behind EURneffy’s efficacy and safety. The surrogate pharmacodynamic endpoints and evaluations under diverse conditions (including pediatric use and various nasal conditions) provide robust evidence supporting its approval. Such comprehensive data not only build confidence in the product but also set a strong precedent for future developments in the field.
For retail investors, it's important to consider the long-term market potential of EURneffy. The needle-free aspect and extended shelf-life could position EURneffy as a preferred choice in the market, potentially capturing significant market share from traditional injectable options. However, competition from established injectable products and the need for widespread education on the new administration method may present challenges.
The approval recommendation by the CHMP is a significant milestone for ARS Pharmaceuticals. From a market perspective, EURneffy's potential entry into the European market could represent a substantial revenue stream. The eight-year data exclusivity and ten-year marketing protection provide a formidable competitive moat against generic and biosimilar competition, which is highly beneficial for maintaining market share and profitability.
Regarding industry dynamics, the unique selling proposition of being needle-free addresses a important pain point in emergency allergic treatment, potentially leading to higher adoption rates. However, market penetration will depend on effective collaboration with a pharmaceutical company that already has a solid commercial presence in Europe. This strategic partnership will be vital for ensuring seamless distribution and maximizing reach within the European market.
Investors should also be mindful of the FDA review process, with the PDUFA date set for October 2, 2024. A positive outcome from the FDA would not only bolster the product's standing but also significantly enhance ARS Pharmaceuticals' valuation and market presence globally, beyond just Europe.
From a financial standpoint, the recommendation for EURneffy approval by the CHMP is likely to have a positive impact on ARS Pharmaceuticals' stock price. The announcement could generate investor optimism, potentially leading to a rise in stock value as the market anticipates future revenue growth.
Investors should note that the expected market authorization in Q3 2024 and subsequent availability in Q4 2024 align well with ARS Pharmaceuticals' strategic timeline. This timing allows the company to capitalize on upcoming fiscal periods, which could reflect positively in financial statements and drive shareholder value.
However, it's important to consider the financial implications of additional investments required for marketing and distribution across Europe. While the projected increase in revenue from EURneffy could be substantial, the initial costs associated with product launch and market penetration should not be underestimated. Long-term financial health will depend on how efficiently ARS Pharmaceuticals manages these investments and scales its operations to meet demand.
EURneffy positioned to be the first and only needle-free adrenaline option authorized for emergency treatment of allergic reactions (anaphylaxis) in Europe
Positive CHMP opinion and recommendation for approval of a mixed application for marketing authorization based on comprehensive data package comparing EURneffy to approved injectable products across a range of dosing scenarios as well as supportive historical data from injectable products
Same data package under review by FDA with a PDUFA date of October 2, 2024
SAN DIEGO, June 28, 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 Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion on the application for marketing authorization for EURneffy® (adrenaline nasal spray) and recommended related market authorization in the European Union (EU) for the emergency treatment of allergic reactions (anaphylaxis). The CHMP positive opinion will now be submitted to the European Commission (EC) for the formal marketing authorization process, which is expected to occur in Q3 2024.
“Today’s announcement marks a major milestone in the treatment of severe allergies and moves us one step closer to bringing EURneffy to patients in the EU as the first and only needle-free adrenaline option for the emergency treatment of allergic reactions, up to anaphylaxis,” 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 outcome of allergic reactions.”
The positive opinion and recommendation for approval of a mixed application for marketing authorization grounded on Article 8(3) of Directive 2001/83./EC from the CHMP is based on 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 basis of approval for EURneffy in Europe was efficacy supported by surrogate pharmacodynamic endpoints. 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. The EURneffy mixed application under Article 8(3) of Directive 2001/83./EC will benefit from an eight-year period of data protection whereby another applicant cannot rely on support from the EURneffy application, and a ten-year period of marketing protection during which a generic, hybrid or biosimilar cannot be placed on the market. The issued composition of matter and method of treatment patents covering EURneffy in Europe have an expiration date in 2039.
Following grant of marketing authorization by the EC expected in Q3 2024, ARS Pharma anticipates that EURneffy will be made available to patients in Europe in Q4 2024 by a pharmaceutical company with an already established commercial footprint in Europe.
The same data package reviewed by CHMP that resulted in its positive opinion and approval recommendation was submitted to the U.S. Food and Drug Administration (FDA) on April 2, 2024. FDA acknowledged receipt of the submission and considered it a complete response to the September 19, 2023 action letter with no comments. The company’s New Drug Application is under review by FDA, with a neffy® PDUFA action date assigned by the FDA of October 2, 2024.
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 Europe. 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 developing neffy® (trade name EURneffy in the EU) (previously referred to as ARS-1), 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 approval of neffy in the EU or U.S.; the expected timing for the EC decision; the PDUFA action date for neffy; the needle-free profile of neffy increasing the likelihood that patients will both carry and administer adrenaline; 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 positive opinion from CHMP does not guarantee the EC will approve the related marketing authorization; the ability to obtain and maintain regulatory approval for neffy; potential safety and other complications from neffy; the labelling for neffy, if approved; the scope, progress and expansion of developing and commercializing 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 March 31, 2024, filed with the Securities and Exchange Commission (SEC) on May 9, 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
What is the significance of the CHMP recommendation for EURneffy?
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When will EURneffy be available to patients in Europe?
What data supported the CHMP's positive opinion on EURneffy?
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