ARS Pharmaceuticals Files for Approval of neffy® in Canada and the United Kingdom on Behalf of Licensing Partner ALK-Abelló A/S
ARS Pharmaceuticals (NASDAQ: SPRY) has filed for approval of neffy® (epinephrine nasal spray) 2 mg in Canada and the United Kingdom, where it will be marketed as EURneffy®, through its licensing partner ALK-Abelló A/S. This follows neffy's recent U.S. approval for Type I Allergic Reactions treatment in adults and children weighing ≥30 kg.
The November 2024 licensing agreement with ALK includes exclusive commercialization rights in Europe, Canada, UK, and other regions. ARS Pharma received a $145 million upfront payment and could earn up to $320 million in additional milestones, plus double-digit royalties on net sales. The company will manufacture and supply neffy to ALK.
ARS Pharma now has approval or pending applications in markets representing over 98% of the global epinephrine market. The company maintains U.S. rights and has existing partnerships in China, Japan, Australia, and New Zealand. A Phase 2b trial for chronic urticaria treatment is planned for early 2025.
ARS Pharmaceuticals (NASDAQ: SPRY) ha richiesto l'approvazione per neffy® (spray nasale di epinefrina) 2 mg in Canada e nel Regno Unito, dove sarà commercializzato come EURneffy®, tramite il suo partner di licenza ALK-Abelló A/S. Questo segue l'approvazione recente di neffy negli Stati Uniti per il trattamento delle reazioni allergiche di tipo I in adulti e bambini che pesano ≥30 kg.
L'accordo di licenza di novembre 2024 con ALK include diritti commerciali esclusivi in Europa, Canada, Regno Unito e altre regioni. ARS Pharma ha ricevuto un pagamento iniziale di 145 milioni di dollari e potrebbe guadagnare fino a 320 milioni di dollari in ulteriori traguardi, oltre a royalties a doppia cifra sulle vendite nette. L'azienda produrrà e fornirà neffy ad ALK.
ARS Pharma ha ora approvazioni o richieste in corso in mercati che rappresentano oltre il 98% del mercato globale dell'epinefrina. L'azienda mantiene i diritti negli Stati Uniti e ha partnership esistenti in Cina, Giappone, Australia e Nuova Zelanda. È previsto uno studio di fase 2b per il trattamento dell'orticaria cronica all'inizio del 2025.
ARS Pharmaceuticals (NASDAQ: SPRY) ha presentado una solicitud de aprobación para neffy® (spray nasal de epinefrina) de 2 mg en Canadá y el Reino Unido, donde se comercializará como EURneffy®, a través de su socio de licencia ALK-Abelló A/S. Esto sigue a la reciente aprobación de neffy en EE. UU. para el tratamiento de reacciones alérgicas tipo I en adultos y niños que pesen ≥30 kg.
El acuerdo de licencia de noviembre de 2024 con ALK incluye derechos de comercialización exclusivos en Europa, Canadá, Reino Unido y otras regiones. ARS Pharma recibió un pago inicial de 145 millones de dólares y podría ganar hasta 320 millones de dólares en hitos adicionales, más regalías de dos dígitos sobre las ventas netas. La empresa fabricará y suministrará neffy a ALK.
ARS Pharma ahora tiene aprobaciones o solicitudes pendientes en mercados que representan más del 98% del mercado global de epinefrina. La empresa mantiene los derechos en EE. UU. y tiene asociaciones existentes en China, Japón, Australia y Nueva Zelanda. Se planea un ensayo de fase 2b para el tratamiento de la urticaria crónica a principios de 2025.
ARS Pharmaceuticals (NASDAQ: SPRY)는 캐나다와 영국에서 neffy® (2mg 에피네프린 비강 스프레이)의 승인을 요청했습니다. 여기서 제품은 ALK-Abelló A/S와의 라이센스 파트너십을 통해 EURneffy®로 판매될 예정입니다. 이는 최근 성인 및 30kg 이상의 어린이를 대상으로 한 I형 알레르기 반응 치료를 위한 neffy의 미국 승인에 이어진 것입니다.
2024년 11월 ALK와의 라이센스 계약은 유럽, 캐나다, 영국 및 기타 지역에서의 독점 상업화 권리를 포함합니다. ARS Pharma는 1억 4,500만 달러의 선불금을 받았으며, 추가 이정표에서 최대 3억 2천만 달러를 벌 수 있고, 순매출에 대해 두 자릿수의 로열티를 받을 수 있습니다. 회사는 ALK에 neffy를 제조하고 공급할 것입니다.
ARS Pharma는 이제 전 세계 에피네프린 시장의 98% 이상을 차지하는 시장에서 승인 또는 대기 중인 신청을 보유하고 있습니다. 이 회사는 미국 내 권리를 유지하고 있으며 중국, 일본, 호주 및 뉴질랜드와 기존의 파트너십을 운영하고 있습니다. 만성 두드러기 치료를 위한 2b상 임상시험이 2025년 초에 계획되어 있습니다.
ARS Pharmaceuticals (NASDAQ: SPRY) a déposé une demande d'approbation pour neffy® (spray nasal à l'épinéphrine) de 2 mg au Canada et au Royaume-Uni, où il sera commercialisé sous le nom d'EURneffy®, par le biais de son partenaire de licence ALK-Abelló A/S. Cela fait suite à l'approbation récente de neffy aux États-Unis pour le traitement des réactions allergiques de type I chez les adultes et les enfants pesant ≥30 kg.
Le contrat de licence de novembre 2024 avec ALK inclut des droits de commercialisation exclusifs en Europe, au Canada, au Royaume-Uni et dans d'autres régions. ARS Pharma a reçu un paiement initial de 145 millions de dollars et pourrait gagner jusqu'à 320 millions de dollars en étapes supplémentaires, plus des redevances à deux chiffres sur les ventes nettes. L'entreprise fabriquera et fournira neffy à ALK.
ARS Pharma a désormais des approbations ou des demandes en attente sur des marchés représentant plus de 98 % du marché mondial de l'épinéphrine. L'entreprise conserve les droits aux États-Unis et a des partenariats existants en Chine, au Japon, en Australie et en Nouvelle-Zélande. Un essai de phase 2b pour le traitement de l'urticaire chronique est prévu pour début 2025.
ARS Pharmaceuticals (NASDAQ: SPRY) hat die Genehmigung für neffy® (2 mg Epinephrin-Nasenspray) in Kanada und dem Vereinigten Königreich beantragt, wo es über seinen Lizenzpartner ALK-Abelló A/S unter dem Namen EURneffy® vermarktet werden soll. Dies folgt auf die kürzliche US-Zulassung von neffy zur Behandlung von Typ-I-Allergie-Reaktionen bei Erwachsenen und Kindern mit einem Gewicht von ≥30 kg.
Die Lizenzvereinbarung mit ALK vom November 2024 umfasst exklusive Vermarktungsrechte in Europa, Kanada, dem Vereinigten Königreich und anderen Regionen. ARS Pharma erhielt eine Vorauszahlung von 145 Millionen $ und könnte bis zu 320 Millionen $ an zusätzlichen Meilensteinen verdienen sowie zweistellige Lizenzgebühren auf den Nettoumsatz erhalten. Das Unternehmen wird neffy für ALK herstellen und liefern.
ARS Pharma hat nun Genehmigungen oder ausstehende Anträge in Märkten, die über 98 % des globalen Epinephrinmarkts repräsentieren. Das Unternehmen hält die US-Rechte und hat bestehende Partnerschaften in China, Japan, Australien und Neuseeland. Eine Phase-2b-Studie zur Behandlung von chronischer Urtikaria ist für Anfang 2025 geplant.
- Received $145 million upfront payment from ALK licensing deal
- Potential for additional $320 million in milestone payments
- Double-digit royalties on net sales in licensed territories
- Market presence in 98% of global epinephrine market
- Recent U.S. FDA approval obtained
- None.
Insights
The regulatory filings in Canada and UK represent a important expansion of neffy's global commercialization strategy. The
The upcoming Phase 2b trial for chronic urticaria could unlock additional value by expanding neffy's addressable market beyond anaphylaxis. The existing partnerships with established players like CSL Seqirus and ALK validate the technology platform and provide multiple shots on goal for revenue generation.
The double-digit royalty structure in the teens suggests strong profit potential from ex-U.S. sales, while retaining full U.S. rights maintains significant upside for SPRY shareholders. The company's strategic focus on manufacturing and supplying neffy to partners ensures ongoing revenue streams and operational control.
The global epinephrine auto-injector market represents a substantial opportunity, with the U.S., Europe, Canada and UK being key regions. neffy's nasal spray formulation addresses major pain points in the current standard of care, potentially driving rapid market adoption. The licensing deal with ALK is particularly strategic as they have established commercial infrastructure and deep relationships with healthcare providers in the target markets.
Think of this expansion like setting up franchise locations in prime real estate - ALK's existing presence in these markets significantly reduces the time and cost typically associated with international launches. The deal structure, combining upfront payment with performance-based milestones, aligns partner incentives while providing SPRY with immediate capital and long-term value capture potential.
Canada and United Kingdom represent two of the largest markets within the ALK portfolio with plans to expand filings of neffy (epinephrine nasal spray) 2 mg in other key global regions
SAN DIEGO, Jan. 06, 2025 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from allergic reactions that could lead to anaphylaxis, announced today that ARS Pharma has filed for approval of neffy® (epinephrine nasal spray) 2 mg in Canada and the United Kingdom (U.K.), where it will be marketed as EURneffy®, on behalf of its licensing partner, ALK- Abelló A/S (ALK). neffy was recently approved in the U.S. for the treatment of Type I Allergic Reactions, including anaphylaxis, in adults and children who weigh ≥30 kg (66 lbs.). In November 2024, ARS Pharma announced a licensing agreement providing ALK with exclusive rights to commercialize neffy in Europe, Canada, United Kingdom and certain other geographies outside of the U.S.
“Building upon the approval of neffy in the U.S. and Europe for the emergency treatment of severe allergic reactions, we are committed to helping facilitate access to this life-saving treatment worldwide,” says Richard Lowenthal, Co-Founder, President and CEO of ARS Pharma. “With submission in Canada and the U.K., ARS Pharma now has approval or has filed for approval in jurisdictions comprising more than 98 percent of the current world market for epinephrine. We look forward to hearing from the regulatory agencies following their review of the applications.”
Under the terms of the licensing agreement, ARS Pharma received an upfront payment of
ARS Pharma retains all U.S. rights for neffy and has existing licensing partnerships in China, Japan, Australia and New Zealand with Pediatrix Therapeutics, Alfresa Pharma, and CSL Seqirus, respectively.
ARS Pharma is also evaluating its intranasal epinephrine technology for the treatment of acute flares in patients with chronic urticaria, with plans to begin a Phase 2b clinical trial in early 2025. The license agreement with ALK also provides them exclusive rights for any new indications in the licensed territories.
About neffy®
neffy is an intranasal epinephrine product for patients with Type I allergic reactions due to insect stings or bites, foods, medicinal products, other allergens, as well as idiopathic or exercise induced anaphylaxis that could lead to life-threatening anaphylaxis.
INDICATION AND IMPORTANT SAFETY INFORMATION FOR neffy (epinephrine nasal spray)
INDICATION
neffy 2 mg is indicated for emergency treatment of Type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh 30 kg or greater.
IMPORTANT SAFETY INFORMATION
It is recommended that patients are prescribed and have immediate access to two neffy nasal sprays at all times. In the absence of clinical improvement or if symptoms worsen after initial treatment, administer a second dose of neffy in the same nostril with a new nasal spray starting 5 minutes after the first dose.
neffy is for use in the nose only.
Advise patients when to seek emergency medical assistance for close monitoring of the anaphylactic episode and in the event further treatment is required.
Absorption of neffy may be affected by underlying structural or anatomical nasal conditions.
Administer with caution to patients who have heart disease; epinephrine may aggravate angina pectoris or produce ventricular arrhythmias. Arrhythmias, including fatal ventricular fibrillation, have been reported, particularly in patients with underlying cardiac disease or taking cardiac glycosides, diuretics, or anti-arrhythmics.
The presence of a sulfite in neffy should not deter use.
neffy may alter nasal mucosa for up to 2 weeks after administration and increase systemic absorption of nasal products, including neffy.
Patients with certain medical conditions or who take certain medications for allergies, depression, thyroid disorders, diabetes, and hypertension, may be at greater risk for adverse reactions.
Epinephrine can temporarily exacerbate the underlying condition or increase symptoms in patients with the following: hyperthyroidism, Parkinson’s disease, diabetes, renal impairment. Epinephrine should be administered with caution in patients with these conditions, including elderly patients and pregnant women.
Adverse reactions to neffy may include throat irritation, intranasal paresthesia, headache, nasal discomfort, feeling jittery, paresthesia, fatigue, tremor, rhinorrhea, nasal pruritus, sneezing, abdominal pain, gingival pain, hypoesthesia oral, nasal congestion, dizziness, nausea, and vomiting.
These are not all of the possible side effects of neffy. To report suspected adverse reactions, contact ARS Pharmaceuticals Operations, Inc. at 1-877-MY-NEFFY (877-696-3339) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For additional information on neffy, please see Full Prescribing Information at www.neffy.com.
About Type I Allergic Reactions Including Anaphylaxis
Type I 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 FDA-approved medication for these reactions. While epinephrine 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. There are approximately 40 million people in the United States who experience Type I allergic reactions. Of this group, over the last three years, approximately 20 million people have been diagnosed and treated for severe Type I allergic reactions that may lead to anaphylaxis, but (in 2023, for example) only 3.2 million filled their active epinephrine autoinjector prescription, and of those, only half consistently carry their prescribed autoinjector. 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 Pharmaceuticals is a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect patients from allergic reactions that could lead to anaphylaxis. The Company is commercializing neffy® 2 mg (trade name EURneffy® in the EU) (previously referred to as ARS-1), an epinephrine nasal spray indicated in the U.S. for emergency treatment of Type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh 30 kg or greater, and in the EU for emergency treatment of allergic reactions (anaphylaxis) due to insect stings or bites, foods, medicinal products, other allergens, as well as idiopathic or exercise induced anaphylaxis in adults and children who weigh 30 kg or greater. 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 expectation that neffy will save lives; the effectiveness of neffy; the expected timing for receiving regulatory approval in the U.K. and Canada; the plans and expected timing for initiating a Phase 2b clinical trial to evaluate neffy for the treatment of chronic urticaria; 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,” “if,” “may,” “potential,” “on track to,” “plans,” “will,” “would,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon ARS Pharmaceuticals’ 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: potential safety and other complications from neffy; ARS Pharmaceuticals’ reliance on its licensing partners; the ability to obtain and maintain regulatory approval for neffy in any indication in the U.K. and Canada; whether the completed studies conducted will be sufficient to obtain regulatory approval for neffy in the U.K. and Canada; ARS Pharmaceuticals’ ability to achieve the milestones needed to receive milestone payments under the ALK license agreement; 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 Pharmaceuticals’ 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 Pharmaceuticals’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, filed with the Securities and Exchange Commission (“SEC”) on November 13, 2024. These documents can also be accessed on ARS Pharmaceuticals’ website at www.ars-pharma.com by clicking on the link “Financials & Filings” under the “Investors & Media” tab.
The forward-looking statements included in this press release are made only as of the date hereof. ARS Pharmaceuticals assumes no obligation and does not intend to update these forward-looking statements, except as required by law.
ARS Investor Contact:
Justin Chakma
ARS Pharmaceuticals
justinc@ars-pharma.com
ARS Media Contact:
Christy Curran
Sam Brown Inc.
615.414.8668
christycurran@sambrown.com
FAQ
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