Windtree Announces Expansion of Patents with Issuance of Istaroxime Patent for Hong Kong
Windtree Therapeutics (WINT) has announced the issuance of an istaroxime patent in Hong Kong, valid until 2039. The patent covers formulations and methods of use for istaroxime in acute heart failure (AHF) treatment. This development supports the company's licensing agreement with Lee's Pharmaceutical, which is planning Phase 3 trials in Greater China. Lee's will fund all regional development, with Windtree maintaining protocol authority. The agreement could yield up to $138 million in milestones plus double-digit royalties for Windtree. Istaroxime, studied in four positive Phase 2 trials, is designed to improve heart function while maintaining renal function.
Windtree Therapeutics (WINT) ha annunciato l'emissione di un brevetto per l'istaroxime a Hong Kong, valido fino al 2039. Il brevetto copre formulazioni e metodi di utilizzo dell'istaroxime nel trattamento dell'insufficienza cardiaca acuta (AHF). Questa novità supporta l'accordo di licenza dell'azienda con Lee's Pharmaceutical, che prevede di avviare studi di fase 3 nella Grande Cina. Lee's finanzierà tutto lo sviluppo regionale, mentre Windtree manterrà l'autorità del protocollo. L'accordo potrebbe generare fino a 138 milioni di dollari in traguardi più royalties a doppia cifra per Windtree. L'istaroxime, studiato in quattro trial di fase 2 positivi, è progettato per migliorare la funzione cardiaca mantenendo la funzione renale.
Windtree Therapeutics (WINT) ha anunciado la emisión de una patente para istaroxima en Hong Kong, válida hasta 2039. La patente cubre formulaciones y métodos de uso de istaroxima en el tratamiento de insuficiencia cardíaca aguda (AHF). Este desarrollo respalda el acuerdo de licencia de la compañía con Lee's Pharmaceutical, que planea ensayos de Fase 3 en Gran China. Lee's financiará todo el desarrollo regional, mientras que Windtree mantendrá la autoridad del protocolo. El acuerdo podría generar hasta 138 millones de dólares en hitos más regalías de dos dígitos para Windtree. La istaroxima, estudiada en cuatro ensayos de Fase 2 positivos, está diseñada para mejorar la función cardíaca mientras se conserva la función renal.
Windtree Therapeutics (WINT)는 홍콩에서 2039년까지 유효한 이스타록심 특허 발급을 발표했습니다. 이 특허는 급성 심부전(AHF) 치료를 위한 이스타록심의 제형 및 사용 방법을 포함합니다. 이 개발은 Lee's Pharmaceutical과의 라이센스 계약을 지원하며, Lee's는 대만에서 3상 임상시험을 계획하고 있습니다. Lee's는 모든 지역 개발을 자금 지원할 것이며, Windtree는 프로토콜 권한을 유지할 것입니다. 이 계약은 Windtree에게 1억 3천8백만 달러까지의 마일스톤과 두 자릿수의 로열티가 발생할 수 있습니다. 이스타록심은 네 개의 긍정적인 2상 임상시험에서 연구되었으며, 심장 기능을 개선하고 신장 기능을 유지하도록 설계되었습니다.
Windtree Therapeutics (WINT) a annoncé l'émission d'un brevet pour l'istaroxime à Hong Kong, valable jusqu'en 2039. Le brevet couvre les formulations et les méthodes d'utilisation de l'istaroxime dans le traitement de l'insuffisance cardiaque aiguë (AHF). Ce développement soutient l'accord de licence de l'entreprise avec Lee's Pharmaceutical, qui prévoit des essais de phase 3 en Chine continentale. Lee's financera l'ensemble du développement régional, Windtree conservant l'autorité du protocole. Cet accord pourrait générer jusqu'à 138 millions de dollars en étapes franchies, ainsi que des redevances à deux chiffres pour Windtree. L'istaroxime, étudié lors de quatre essais de phase 2 positifs, est conçu pour améliorer la fonction cardiaque tout en maintenant la fonction rénale.
Windtree Therapeutics (WINT) hat die Erteilung eines Patents für Istaroxim in Hongkong bekanntgegeben, das bis 2039 gültig ist. Das Patent umfasst Formulierungen und Methoden zur Anwendung von Istaroxim bei der Behandlung von akuter Herzinsuffizienz (AHF). Diese Entwicklung unterstützt die Lizenzvereinbarung des Unternehmens mit Lee's Pharmaceutical, welches Phase-3-Studien in Großchina plant. Lee's wird die gesamte regionale Entwicklung finanzieren, während Windtree die Protokollautonomie behält. Die Vereinbarung könnte Windtree bis zu 138 Millionen Dollar an Meilensteinen sowie zweistellige Lizenzgebühren einbringen. Istaroxim, das in vier positiven Phase-2-Studien untersucht wurde, ist darauf ausgelegt, die Herzfunktion zu verbessern und gleichzeitig die Nierenfunktion aufrechtzuerhalten.
- Patent protection secured in Hong Kong until 2039 for istaroxime formulations
- Potential revenue of up to $138 million in milestones plus double-digit royalties from Lee's Pharmaceutical agreement
- Partner-funded Phase 3 development program in Greater China
- Successful completion of four positive Phase 2 trials
- None.
Insights
The issuance of the Hong Kong patent for istaroxime formulations significantly strengthens Windtree's intellectual property portfolio in Asia. The patent, extending until 2039, provides important market exclusivity and complements the existing mainland China patent. This IP protection is particularly valuable for the potential
The broad claim scope covering formulations and methods of use, both alone and in combination therapy, creates multiple layers of protection. With Lee's funding the Phase 3 program in Greater China while Windtree maintains protocol control, this creates a favorable risk-adjusted scenario for monetizing the IP rights. The long patent life through 2039 ensures market protection well beyond potential commercialization.
The acute heart failure market represents a significant opportunity, being the leading cause of hospitalization for patients over 65 in many regions. The partnership with Lee's Pharmaceutical strategically positions Windtree in the lucrative Greater China market while minimizing development costs. The deal structure, including low double-digit royalties and substantial milestone payments, provides multiple revenue streams.
With four positive Phase 2 trials completed and Lee's commitment to fund Phase 3 development, the risk-reward profile is attractive for a small-cap biotech. The dual development strategy - pursuing cardiogenic shock globally while Lee's advances acute heart failure regionally - maximizes the asset's potential value across different indications.
Supports Licensing Partner’s Phase 3 Activities in Acute Heart Failure
WARRINGTON, Pa., Nov. 04, 2024 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions and diseases, today announced the issuance of an istaroxime patent for Hong Kong. The patent is entitled, “Istaroxime-containing intravenous formulation for the treatment of heart failure (AHF).” The claims are directed formulations comprising istaroxime, pharmaceutically acceptable salts thereof, and methods of use, alone, or in combination with other agents useful for the treatment and management of AHF. The application number is 62021023600.1. The Notice of Publication of the Registration and Grant has a date of October 9, 2024 and will expire in 2039. The patent for mainland China was granted earlier this year (patent number ZL201980003356.1).
Windtree’s licensing partner, Lee’s Pharmaceutical (HK) Ltd. (“Lee’s”), is planning a Phase 3 program in acute heart failure for its Greater China territory. In alignment with the licensing agreement, Lee’s is funding all trials and development conducted in their region. Windtree is collaborating with Lee’s on the Phase 3 program and has final signing authority on the protocol. Acute heart failure is the #1 cause of hospitalization in patients >65 years of age in many regions of the world and as Windtree advances its cardiogenic shock program globally, Lee’s is progressing the acute heart failure intended indication.
Istaroxime is a novel, first-in-class investigational therapy that is intended to improve systolic contraction and diastolic relaxation of the heart while also increasing blood pressure and maintaining renal function with a generally favorable safety profile. Istaroxime has been studied in four positive Phase 2 trials enrolling patients with acute heart failure and early cardiogenic shock due to heart failure.
“Acute heart failure is responsible for millions of hospitalizations annually throughout the world and there is a high need for innovation in drug treatment,” said Craig Fraser, Chairman and CEO of Windtree. “Expansion of our patent estate helps support our Greater China regional licensing agreement with Lee’s, through which Windtree may receive up to
About Istaroxime
Istaroxime is a first-in-class dual-mechanism therapy designed to improve both systolic and diastolic cardiac function. Istaroxime is designed as 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 have demonstrated 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 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 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’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 economic and social consequences of the COVID-19 pandemic and 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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