ARS Pharmaceuticals Advances neffy® Approval in Major Markets

ARS Pharmaceuticals Takes Key Steps for neffy® Approval

SAN DIEGO — ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a leading biopharmaceutical company, is making strides to enhance the lives of individuals at risk of severe allergic reactions. Recently, the company announced that it has filed for the regulatory approval of its innovative product, neffy® (epinephrine nasal spray) 2 mg, in Canada and the United Kingdom (U.K.). This noteworthy move showcases a commitment to ensuring more patients have access to life-saving treatments for anaphylaxis.

Understanding the Significance of neffy®

Both Canada and the U.K. represent significant markets for ARS Pharmaceuticals, being integral parts of the worldwide ALK portfolio. In addition, neffy® has already obtained approval in the U.S. for treating Type I allergic reactions, including anaphylaxis, making its international expansion a natural next step for ARS Pharma.

The Licensing Partnership

In September 2024, ARS Pharmaceuticals finalized a licensing agreement with ALK-Abelló A/S (ALK), granting the latter exclusive rights to market and distribute neffy® across Europe, Canada, the U.K., and select other regions outside the U.S. This agreement not only strengthens ARS Pharma’s market presence but also unlocks a substantial financial potential, with an upfront payment of $145 million and up to an additional $320 million available through regulatory and sales milestones. Moreover, ARS Pharma will supply neffy® directly to ALK, ensuring that the product is readily available in these new markets.

Global Market Reach

With the recent filing, ARS Pharma has effectively positioned itself to hold approvals in areas accounting for over 98 percent of the global epinephrine market. The company's CEO, Richard Lowenthal, expressed enthusiasm about this potential reach and the future of patient access to neffy® as a critical emergency response tool for allergic reactions.

Clinical Advancements with neffy®

Beyond expanding access, ARS Pharmaceuticals is also looking to innovate further. The company is currently evaluating its intranasal epinephrine technology as a treatment for patients experiencing acute flares of chronic urticaria, with plans to initiate a Phase 2b clinical trial soon. The exclusive rights outlined in the licensing agreement with ALK also cover any new indications developed within the licensed territories, potentially paving the way for broader applications of neffy®.

About neffy® and Its Importance

neffy® is a groundbreaking intranasal epinephrine product designed to aid patients suffering from Type I allergic reactions. These reactions can occur due to various triggers, including insect stings, certain foods, and medications, leading to potentially life-threatening conditions. The unique delivery method of neffy® addresses prevalent issues associated with conventional epinephrine autoinjectors, such as anxiety around needles and device complexity, fostering better adherence during emergencies.

Real-World Impact

Statistics show a daunting reality: approximately 40 million people in the United States experience Type I allergic reactions. Despite the significant number of individuals diagnosed with severe allergic responses, many still face obstacles when it comes to treatment accessibility and delivery. Thus, neffy® aims to revolutionize how these patients respond to allergic emergencies, enhancing their overall safety and confidence.

About ARS Pharmaceuticals, Inc.

ARS Pharmaceuticals, Inc. is dedicated to empowering patients and caregivers to manage severe allergic reactions effectively. By commercializing neffy®, ARS Pharma seeks to transform existing emergency protocols for allergic reactions, providing a much-needed solution for many individuals. Interested parties can find additional information on their website.

Frequently Asked Questions

1. What is neffy® and its purpose?

neffy® is an intranasal epinephrine spray used for the emergency treatment of Type I allergic reactions, including anaphylaxis.

2. Where has ARS Pharmaceuticals filed for neffy® approval?

ARS Pharmaceuticals has filed for approval in Canada and the United Kingdom.

3. How does neffy® differ from traditional epinephrine injectors?

neffy® utilizes a nasal spray delivery method, eliminating needle-related anxiety and improving access during emergencies.

4. What clinical trials is ARS Pharma planning for neffy®?

They aim to begin a Phase 2b clinical trial to evaluate neffy® for treating chronic urticaria soon.

5. What are the market implications of the licensing agreement with ALK?

The agreement allows ALK to commercialize neffy® across Europe, Canada, and the U.K., potentially increasing patient access significantly.

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