Windtree Announces Istaroxime Exclusivity and Intellectual Property Potential Strategy for US
Windtree Therapeutics (NASDAQ: WINT) has announced potential U.S. exclusivity strategies for its drug candidate istaroxime in treating cardiogenic shock. If granted New Chemical Entity (NCE) designation by the FDA, istaroxime could receive 7.5 years of U.S. market exclusivity upon approval. The company also holds a U.S. method of use patent extending protection until 2039, with a pending patent that could provide coverage until 2043.
The company is currently conducting the SEISMiC C Phase 2 study, a global placebo-controlled trial evaluating istaroxime in SCAI Stage C cardiogenic shock patients. The study's primary endpoint focuses on systolic blood pressure profile over 6 hours of treatment, with an interim analysis planned for Q3 2025.
Windtree Therapeutics (NASDAQ: WINT) ha annunciato potenziali strategie di esclusività negli Stati Uniti per il suo candidato farmaco istaroxime nel trattamento dello shock cardiogenico. Se l'FDA concederà la designazione di Nuova Entità Chimica (NCE), istaroxime potrebbe ottenere 7,5 anni di esclusività sul mercato USA dopo l'approvazione. L'azienda detiene inoltre un brevetto statunitense per il metodo d'uso che estende la protezione fino al 2039, con un brevetto in attesa che potrebbe estendere la copertura fino al 2043.
Attualmente la società sta conducendo lo studio SEISMiC C di Fase 2, uno studio globale controllato con placebo che valuta istaroxime in pazienti con shock cardiogenico di stadio SCAI C. L'endpoint primario dello studio riguarda il profilo della pressione sistolica durante 6 ore di trattamento, con un'analisi intermedia prevista per il terzo trimestre del 2025.
Windtree Therapeutics (NASDAQ: WINT) ha anunciado posibles estrategias de exclusividad en EE.UU. para su candidato a medicamento istaroxime en el tratamiento del shock cardiogénico. Si la FDA otorga la designación de Nueva Entidad Química (NCE), istaroxime podría obtener 7,5 años de exclusividad en el mercado estadounidense tras su aprobación. La empresa también posee una patente de método de uso en EE.UU. que extiende la protección hasta 2039, con una patente pendiente que podría cubrir hasta 2043.
Actualmente, la compañía está llevando a cabo el estudio SEISMiC C de fase 2, un ensayo global controlado con placebo que evalúa istaroxime en pacientes con shock cardiogénico en estadio SCAI C. El objetivo principal del estudio se centra en el perfil de presión arterial sistólica durante 6 horas de tratamiento, con un análisis intermedio previsto para el tercer trimestre de 2025.
Windtree Therapeutics (NASDAQ: WINT)는 심인성 쇼크 치료를 위한 약물 후보인 이스타록심에 대한 미국 내 독점 전략 가능성을 발표했습니다. FDA로부터 신규 화학 물질(NCE) 지정을 받으면, 이스타록심은 승인 시 미국 시장에서 7.5년간 독점권을 부여받을 수 있습니다. 또한 회사는 2039년까지 보호되는 미국 사용 방법 특허를 보유하고 있으며, 2043년까지 보호를 연장할 수 있는 특허 출원도 진행 중입니다.
현재 회사는 SEISMiC C 2상 임상시험을 진행 중이며, 이는 SCAI 단계 C 심인성 쇼크 환자를 대상으로 하는 글로벌 위약 대조 시험입니다. 연구의 주요 목표는 6시간 치료 동안의 수축기 혈압 프로파일이며, 2025년 3분기에 중간 분석이 예정되어 있습니다.
Windtree Therapeutics (NASDAQ : WINT) a annoncé des stratégies potentielles d'exclusivité aux États-Unis pour son candidat-médicament istaroxime dans le traitement du choc cardiogénique. Si la FDA accorde la désignation de Nouvelle Entité Chimique (NCE), istaroxime pourrait bénéficier de 7,5 ans d'exclusivité sur le marché américain après approbation. L'entreprise détient également un brevet américain pour le mode d'utilisation, prolongeant la protection jusqu'en 2039, avec un brevet en attente pouvant étendre la couverture jusqu'en 2043.
La société mène actuellement l'étude SEISMiC C de phase 2, un essai mondial contrôlé par placebo évaluant istaroxime chez des patients en choc cardiogénique au stade SCAI C. Le critère principal de l'étude porte sur le profil de la pression artérielle systolique sur 6 heures de traitement, avec une analyse intermédiaire prévue pour le troisième trimestre 2025.
Windtree Therapeutics (NASDAQ: WINT) hat potenzielle US-Exklusivitätsstrategien für seinen Wirkstoffkandidaten Istaroxim zur Behandlung des kardiogenen Schocks angekündigt. Wenn die FDA die New Chemical Entity (NCE) Kennzeichnung erteilt, könnte Istaroxim nach Zulassung 7,5 Jahre US-Markt-Exklusivität erhalten. Das Unternehmen besitzt außerdem ein US-Patent für die Anwendungsweise, das den Schutz bis 2039 verlängert, sowie ein anhängiges Patent, das den Schutz bis 2043 ausweiten könnte.
Derzeit führt das Unternehmen die SEISMiC C Phase-2-Studie durch, eine globale placebokontrollierte Studie zur Bewertung von Istaroxim bei Patienten mit kardiogenem Schock im SCAI-Stadium C. Der primäre Endpunkt der Studie ist das systolische Blutdruckprofil über 6 Stunden Behandlung, mit einer Zwischenanalyse geplant für das dritte Quartal 2025.
- Potential 7.5 years of U.S. market exclusivity through NCE designation
- Existing method of use patent protection until 2039
- Additional pending patent could extend protection until 2043
- Global Phase 2 trial ongoing with interim analysis expected in Q3 2025
- Drug approval still pending and not guaranteed
- NCE designation and exclusivity dependent on FDA approval
- Competition from current standard of care treatments (inotropes/vasopressors)
Insights
Windtree's dual IP strategy could provide 7.5 years regulatory exclusivity plus patent protection until 2039, significantly enhancing istaroxime's commercial potential if approved.
The intellectual property strategy outlined by Windtree for istaroxime represents a well-structured approach to market protection. The potential New Chemical Entity designation would provide two valuable protections: 5 years of data exclusivity plus an additional 2.5 years stay on generic approvals during patent litigation. This regulatory exclusivity layer is particularly valuable for creating an initial competitive moat.
More significantly, Windtree has secured a method-of-use patent extending protection until 2039, with another pending patent potentially extending coverage until 2043. This layered approach is textbook pharmaceutical IP strategy - using regulatory exclusivity as initial protection while relying on method patents for longer-term coverage.
The combination is particularly powerful for cardiogenic shock, where limited treatment options exist. Method-of-use patents are typically more defensible when covering specific indications with defined treatment protocols, which appears to be Windtree's approach. This strategy doesn't guarantee commercial success, but does provide the necessary protection framework should istaroxime receive FDA approval through the ongoing clinical program.
Windtree's istaroxime program advances with strong IP planning and upcoming Phase 2 interim analysis in Q3 2025 for critical cardiogenic shock indication.
Windtree's clinical development program for istaroxime in cardiogenic shock is progressing with a clear timeline - the Phase 2 SEISMiC C interim analysis is expected in Q3 2025. The study design reveals important strategic decisions: it's a global trial spanning the US, Europe and Latin America, suggesting preparation for worldwide commercialization if successful.
The trial design is methodologically robust - placebo-controlled and double-blinded with istaroxime added to current standard of care. The company is targeting SCAI Stage C cardiogenic shock, positioning the therapy as a potential intervention before patients progress to more severe stages requiring mechanical support.
The primary endpoint focuses on systolic blood pressure profile over the first 6 hours, with multiple secondary endpoints including cardiac function measurements, vasopressor-inotrope scores, and progression rates to more severe shock stages. These endpoints align with clinical relevance in this critical condition.
This development approach, combined with the extensive IP planning, indicates systematic preparation for potential commercialization. However, investors should recognize that full approval would still require successful completion of this trial and likely subsequent Phase 3 studies.
If istaroxime is granted the new chemical entity designation from FDA, it could provide 7.5 years of U.S. exclusivity and additionally the istaroxime U.S. issued method of use patent protects until 2039 for its planned initial indication in cardiogenic shock
WARRINGTON, Pa., May 06, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on becoming a revenue generating company and advancing early and late-stage innovative therapies for critical conditions and diseases, is pleased to announce it has received advice from intellectual property and FDA experts highlighting a U.S. strategy that can provide 7.5 years of U.S. exclusivity for istaroxime if it is approved by the FDA in cardiogenic shock. Specifically, as a never-before-approved active ingredient, istaroxime may receive New Chemical Entity (NCE) designation from the FDA. If the new drug application is approved with such a designation, istaroxime would be entitled to 5 years of data exclusivity, and a stay of FDA approval of any generic application equal to 7.5 years from the date of istaroxime’s FDA approval should any generic company challenge the patents that Windtree has obtained or is pursuing and if Windtree files a patent infringement lawsuit in response to such a challenge.
Istaroxime also has a USPTO issued method of use patent providing protection until 2039 and a pending method of use patent providing protection until 2043.
“We believe that the NCE exclusivity strategy is an attractive approach if istaroxime receives FDA approval in cardiogenic shock,” said Jed Latkin, Chief Executive Officer of Windtree. “It would be combined with our method of use patents for istaroxime in the U.S.” Mr. Latkin continued, “We continue our focused development and IP strategic planning for istaroxime in cardiogenic shock and our next milestone is a planned interim analysis of our Phase 2 cardiogenic shock SCAI Stage C study in Q3, 2025.”
The istaroxime SCAI Stage C study (SEISMiC C) is a global trial including sites in the U.S. Europe and Latin America. It is a placebo-controlled, double-blinded study with istaroxime being added to current standard of care, inotropes or vasopressors. The effect of istaroxime in addition to these therapies will be assessed for 6 hours and based on the patient’s condition, a withdrawal of the other therapies. The primary endpoint of the study is assessment of systolic blood pressure (SBP) profile over the first 6 hours of treatment. Other key study measurements include various measures of cardiac function, SBP changes at specified timepoints, the vasopressor-inotrope score, avoidance of progression to SCAI Stage D or E cardiogenic shock and need for mechanical cardiac support, time to treatment failure, arrhythmia assessments, days alive and out of the hospital through day 30, physiologic measures (e.g., cardiac index) and length of stay in the intensive care unit and hospital.
About Istaroxime
Istaroxime is a first-in-class dual-mechanism therapy designed to improve both systolic and diastolic cardiac function. Istaroxime is a positive inotropic agent that increases myocardial contractility through inhibition of Na+/K+- ATPase with a complimentary mechanism that facilitates myocardial relaxation through activation of the SERCA2a calcium pump on the sarcoplasmic reticulum enhancing calcium reuptake from the cytoplasm. Data from multiple Phase 2 studies in patients with early cardiogenic shock or acute decompensated heart failure demonstrate that istaroxime infused intravenously significantly improves cardiac function and blood pressure without increasing heart rate or the incidence of cardiac rhythm disturbances.
About Windtree Therapeutics, Inc.
Windtree Therapeutics, Inc. is a biotechnology company focused on becoming a revenue generating biotech and advancing early and late-stage innovative therapies for critical conditions and diseases. Windtree’s portfolio of product candidates includes istaroxime, a Phase 2 candidate with SERCA2a activating properties for acute heart failure and associated cardiogenic shock, preclinical SERCA2a activators for heart failure and preclinical precision aPKCi inhibitors that are being developed for potential in rare and broad oncology applications. Windtree also has a licensing business model with partnership out-licenses currently in place.
Forward Looking Statements
This press release contains statements related to the acquisition of the real estate property discussed above; rental revenue if such property is acquired; potential clinical effects of istaroxime; the potential benefits and safety of istaroxime; the clinical development of istaroxime; and our research and development program for treating patients in early cardiogenic shock due to heart failure. Such statements constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are based on information available to the Company as of the date of this press release and are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the Company’s current expectations. Examples of such risks and uncertainties include, among other things: the Company could lose its deposit on the real estate property discussed above; the Company may fail to acquire such real estate property; the Company’s ability to acquire revenue generating subsidiaries; the market’s reaction to potential acquisitions by the Company; the Company’s ability to secure significant additional capital as and when needed; the Company’s ability to achieve the intended benefits of the aPKCi asset acquisition with Varian Biopharmaceuticals, Inc.; the Company’s risks and uncertainties associated with the success and advancement of the clinical development programs for istaroxime and the Company’s other product candidates, including preclinical oncology candidates; the Company’s ability to access the debt or equity markets; the Company’s ability to manage costs and execute on its operational and budget plans; the results, cost and timing of the Company’s clinical development programs, including any delays to such clinical trials relating to enrollment or site initiation; risks related to technology transfers to contract manufacturers and manufacturing development activities; delays encountered by the Company, contract manufacturers or suppliers in manufacturing drug products, drug substances, and other materials on a timely basis and in sufficient amounts; risks relating to rigorous regulatory requirements, including that: (i) the U.S. Food and Drug Administration or other regulatory authorities may not agree with the Company on matters raised during regulatory reviews, may require significant additional activities, or may not accept or may withhold or delay consideration of applications, or may not approve or may limit approval of the Company’s product candidates, and (ii) changes in the national or international political and regulatory environment may make it more difficult to gain regulatory approvals and risks related to the Company’s efforts to maintain and protect the patents and licenses related to its product candidates; risks that the Company may never realize the value of its intangible assets and have to incur future impairment charges; risks related to the size and growth potential of the markets for the Company’s product candidates, and the Company’s ability to service those markets; the Company’s ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; the rate and degree of market acceptance of the Company’s product candidates, if approved; the impacts of political unrest, including as a result of geopolitical tension, including the conflict between Russia and Ukraine, the People’s Republic of China and the Republic of China (Taiwan), and the evolving events in the Middle East, and any sanctions, export controls or other restrictive actions that may be imposed by the United States and/or other countries which could have an adverse impact on the Company’s operations, including through disruption in supply chain or access to potential international clinical trial sites, and through disruption, instability and volatility in the global markets, which could have an adverse impact on the Company’s ability to access the capital markets. These and other risks are described in the Company’s periodic reports, including its Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission and available at www.sec.gov. Any forward-looking statements that the Company makes in this press release speak only as of the date of this press release. The Company assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
Contact Information:
Eric Curtis
ecurtis@windtreetx.com
FAQ
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