Milestone® Pharmaceuticals Notice of Allowance on New U.S. Patent for Etripamil
Milestone Pharmaceuticals (NASDAQ: MIST) has received a Notice of Allowance from the USPTO for a new Method of Use patent for etripamil nasal spray (CARDAMYST™), their lead product for PSVT management. The patent covers the repeat dose regimen used in the RAPID Phase 3 study and proposed in the CARDAMYST New Drug Application (NDA).
The patent will extend CARDAMYST's intellectual property protection in the US until July 2042, adding 6 years of protection. The repeat dose regimen allows patients to administer a second 70 mg dose if PSVT symptoms persist 10 minutes after the initial dose.
The FDA is currently reviewing CARDAMYST's NDA with a PDUFA target date of March 27, 2025. Milestone is preparing for a potential commercial launch in mid-2025.
Milestone Pharmaceuticals (NASDAQ: MIST) ha ricevuto un Avviso di Concessione dall'USPTO per un nuovo brevetto relativo a un Metodo di Utilizzo per etripamil spray nasale (CARDAMYST™), il loro prodotto principale per la gestione della PSVT. Il brevetto copre il regime di dosaggio ripetuto utilizzato nello studio RAPID di Fase 3 e proposto nella Domanda di Nuovo Farmaco (NDA) per CARDAMYST.
Il brevetto estenderà la protezione della proprietà intellettuale di CARDAMYST negli Stati Uniti fino a luglio 2042, aggiungendo 6 anni di protezione. Il regime di dosaggio ripetuto consente ai pazienti di somministrare una seconda dose di 70 mg se i sintomi della PSVT persistono 10 minuti dopo la dose iniziale.
La FDA sta attualmente esaminando la NDA di CARDAMYST con una data obiettivo PDUFA del 27 marzo 2025. Milestone si sta preparando per un possibile lancio commerciale a metà 2025.
Milestone Pharmaceuticals (NASDAQ: MIST) ha recibido un Aviso de Concesión de la USPTO para una nueva patente de Método de Uso para etripamil spray nasal (CARDAMYST™), su producto principal para el manejo de la PSVT. La patente cubre el régimen de dosis repetidas utilizado en el estudio RAPID de Fase 3 y propuesto en la Solicitud de Nuevo Medicamento (NDA) para CARDAMYST.
La patente extenderá la protección de la propiedad intelectual de CARDAMYST en los EE. UU. hasta julio de 2042, añadiendo 6 años de protección. El régimen de dosis repetidas permite a los pacientes administrar una segunda dosis de 70 mg si los síntomas de PSVT persisten 10 minutos después de la dosis inicial.
La FDA está revisando actualmente la NDA de CARDAMYST con una fecha objetivo PDUFA del 27 de marzo de 2025. Milestone se está preparando para un posible lanzamiento comercial a mediados de 2025.
Milestone Pharmaceuticals (NASDAQ: MIST)는 PSVT 관리를 위한 주요 제품인 etripamil 비강 스프레이 (CARDAMYST™)의 새로운 사용 방법 특허에 대해 USPTO로부터 허가 통지를 받았습니다. 이 특허는 RAPID 3상 연구에서 사용된 반복 투여 요법과 CARDAMYST의 신약 신청(NDA)에서 제안된 내용을 포함합니다.
이 특허는 CARDAMYST의 지적 재산 보호를 미국에서 2042년 7월까지 연장하며, 6년의 추가 보호를 제공합니다. 반복 투여 요법은 환자가 초기 투여 후 10분 이내에 PSVT 증상이 지속될 경우 두 번째 70mg 용량을 투여할 수 있도록 합니다.
FDA는 현재 CARDAMYST의 NDA를 검토 중이며, PDUFA 목표 날짜는 2025년 3월 27일입니다. Milestone은 2025년 중반에 상업적 출시를 준비하고 있습니다.
Milestone Pharmaceuticals (NASDAQ: MIST) a reçu un Avis d'Autorisation de l'USPTO pour un nouveau brevet de Méthode d'Utilisation pour etripamil spray nasal (CARDAMYST™), leur produit phare pour la gestion de la PSVT. Le brevet couvre le schéma posologique répété utilisé dans l'étude RAPID de Phase 3 et proposé dans la Demande de Nouveau Médicament (NDA) pour CARDAMYST.
Le brevet prolongera la protection de la propriété intellectuelle de CARDAMYST aux États-Unis jusqu'en juillet 2042, ajoutant 6 ans de protection. Le schéma posologique répété permet aux patients d'administrer une deuxième dose de 70 mg si les symptômes de la PSVT persistent 10 minutes après la dose initiale.
La FDA examine actuellement la NDA de CARDAMYST avec une date cible PDUFA du 27 mars 2025. Milestone se prépare à un lancement commercial potentiel à la mi-2025.
Milestone Pharmaceuticals (NASDAQ: MIST) hat von der USPTO eine Genehmigungsmitteilung für ein neues Verwendungspatent für etripamil Nasenspray (CARDAMYST™) erhalten, ihr Hauptprodukt zur Behandlung von PSVT. Das Patent umfasst das wiederholte Dosierungsschema, das in der RAPID Phase 3-Studie verwendet und in dem Antrag auf Zulassung eines neuen Arzneimittels (NDA) für CARDAMYST vorgeschlagen wurde.
Das Patent wird den Schutz des geistigen Eigentums von CARDAMYST in den USA bis Juli 2042 verlängern und 6 Jahre zusätzlichen Schutz bieten. Das wiederholte Dosierungsschema ermöglicht es den Patienten, eine zweite Dosis von 70 mg zu verabreichen, wenn die Symptome der PSVT 10 Minuten nach der ersten Dosis anhalten.
Die FDA prüft derzeit den NDA von CARDAMYST mit einem PDUFA-Zieldatum vom 27. März 2025. Milestone bereitet sich auf einen möglichen kommerziellen Start Mitte 2025 vor.
- Patent extension until 2042, adding 6 years of IP protection
- FDA review of NDA in progress with clear PDUFA date (March 27, 2025)
- Commercial launch planned for mid-2025
- None.
Insights
The Notice of Allowance for CARDAMYST's method-of-use patent represents a significant strategic victory for Milestone Pharmaceuticals, particularly given its proximity to the March 27, 2025 PDUFA date. The patent's extension to 2042 provides important market exclusivity during the critical commercialization phase, effectively creating a 17-year runway for market dominance in PSVT treatment.
The timing is especially strategic as it covers the specific repeat dose regimen (70mg + 70mg after 10 minutes) that's central to their New Drug Application. This patent protection is particularly valuable because method-of-use patents can be more defensible against potential competitors compared to compound patents, as they protect the specific therapeutic approach rather than just the molecule itself.
From a commercial perspective, this patent extension significantly enhances CARDAMYST's market potential. The additional 6 years of protection will be important for:
- Maximizing return on investment during peak sales years
- Deterring potential competitors from developing similar dosing regimens
- Providing a longer window for potential label expansions or new indications
- Strengthening partnering or licensing opportunities
The alignment of the patent with the proposed package insert demonstrates careful IP strategy planning, as it protects the exact dosing regimen that physicians and patients would follow. This comprehensive protection of the commercial protocol significantly enhances Milestone's competitive position in the PSVT market.
Extends US patent protection until 2042
MONTREAL and CHARLOTTE, N.C., Feb. 19, 2025 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST) a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that it has received Notice of Allowance from the United States Patent and Trademark Office (USPTO) on a new Method of Use patent for etripamil nasal spray (proposed trade name CARDAMYST™), its lead investigational product for the management of paroxysmal supraventricular tachycardia (PSVT).
The patent, once issued on U.S. Patent Application No.: 17/865,697, covers the repeat dose regimen used in the RAPID Phase 3 study that evaluated CARDAMYST in PSVT and proposed for the package insert as part of the CARDAMYST New Drug Application (NDA) currently under review by the U.S. Food and Drug Administration (FDA). The issuance of the Notice of Allowance potentially extends our intellectual property protection for CARDAMYST in the United States until July 2042, which is an additional 6 years of potential protection for our intellectual property portfolio.
“This added protection will position us to optimize the commercial value of CARDAMYST,” said Joseph Oliveto, President, and Chief Executive Officer of Milestone Pharmaceuticals. “The new patent underscores Milestone’s continued development of our patent portfolio and our commitment to innovation in cardiology.”
The repeat dose regimen, proposed in the NDA for CARDAMYST, directs the patient to administer a second 70 mg dose of CARDAMYST should the patient continue to experience symptoms from their PSVT episode ten minutes after their initial dose.
Milestone’s NDA for CARDAMYST is currently under review at the FDA with a Prescription Drug User Fee Act (PDUFA) target date of March 27, 2025. The Company continues to advance commercial preparations to support the anticipated launch in mid-2025. The CARDAMYST brand name is conditionally approved by the FDA.
About Etripamil
Etripamil is Milestone's lead investigational product. It is a novel calcium channel blocker nasal spray under clinical development for frequent and often highly symptomatic episodes of PSVT and AFib-RVR. It is designed as a self-administered rapid response therapy for patients thereby bypassing the need for immediate medical oversight. If approved, etripamil is intended to provide health care providers with a new treatment option to enable on-demand care and patient self-management. This portable, self-administered treatment may provide patients with active management and a greater sense of control over their condition. CARDAMYST™, the conditionally approved brand name for etripamil nasal spray, is well studied with a robust clinical trial program that includes a completed Phase 3 clinical-stage program for the treatment of PSVT and Phase 2 trial for the treatment of patients with AFib-RVR.
About Milestone Pharmaceuticals
Milestone Pharmaceuticals Inc. (Nasdaq: MIST) is a biopharmaceutical company developing and commercializing innovative cardiovascular solutions to improve the lives of people living with complex and life-altering heart conditions. The Company’s focus on understanding unmet patient needs and improving the patient experience has led us to develop new treatment approaches that provide patients with an active role in self-managing their care. Milestone's lead investigational product is etripamil, a novel calcium channel blocker nasal spray that is being studied for patients to self-administer without medical supervision to treat symptomatic episodic attacks associated with PSVT and AFib-RVR.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believe," "continue," "could," "demonstrate," "designed," "develop," "estimate," "expect," "may," "pending," "plan," "potential," "progress," "will", “intend” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Milestone's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding the timing and outcomes of future interactions with the FDA, including the PDUFA target date; the potential extension of protection under our intellectual property portfolio; the potential of etripamil to provide health care providers with a new treatment option to enable on-demand care and patient self-management and provide patients with active management and a greater sense of control over their condition. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to, whether our future interactions with the FDA will have satisfactory outcomes; whether and when, if at all, our NDA for etripamil will be approved by the FDA; uncertainties related to the timing of initiation, enrollment, completion, evaluation and results of our clinical trials; risks and uncertainty related to the complexity inherent in cleaning, verifying and analyzing trial data; and whether the clinical trials will validate the safety and efficacy of etripamil for PSVT or other indications, among others, general economic, political, and market conditions, including deteriorating market conditions due to investor concerns regarding inflation, Russian hostilities in Ukraine and ongoing disputes in Israel and Gaza and overall fluctuations in the financial markets in the United States and abroad, risks related to pandemics and public health emergencies, and risks related the sufficiency of Milestone's capital resources and its ability to raise additional capital in the current economic climate. These and other risks are set forth in Milestone's filings with the U.S. Securities and Exchange Commission, including in its annual report on Form 10-K for the year ended December 31, 2023, under the caption "Risk Factors," as such discussion may be updated from time to time by subsequent filings Milestone may make with the U.S. Securities & Exchange Commission. Except as required by law, Milestone assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
Contact:
Kim Fox, Vice President, Communications, kfox@milestonepharma.com
Investor Relations
Chris Calabrese, ccalabrese@lifesciadvisors.com
Kevin Gardner, kgardner@lifesciadvisors.com
FAQ
When will the FDA make a decision on MIST's CARDAMYST NDA?
How long is MIST's patent protection for CARDAMYST extended?
What is the dosing regimen covered in MIST's new CARDAMYST patent?
When does Milestone Pharmaceuticals (MIST) plan to launch CARDAMYST?
