Windtree Therapeutics and Lee's Pharmaceuticals License Istaroxime, Dual SERCA2a Activators, and Rostafuroxin for Greater China/Asia Pacific

Windtree Therapeutics, Inc. (NasdaqCM: WINT), a biotechnology company specializing in advanced interventions for critical cardiovascular disorders, has recently announced a license agreement with Lee’s Pharmaceutical (HK) Limited. This agreement pertains to the development and commercialization of its product candidate istaroxime in Greater China, covering applications for acute heart failure and cardiogenic shock. The deal also includes Windtree’s preclinical next-generation SERCA2a activators, known as dual mechanism SERCA2a activators, and rostafuroxin, a Phase 2 product for hypertension associated with specific genotypes.

Craig Fraser, Windtree’s CEO, expressed confidence in the potential of their pipeline and sees the agreement as a significant step in advancing heart failure treatment. The license deal with Lee’s validates the substantial market opportunity for istaroxime, particularly in Greater China, which has a substantial heart failure patient population. Windtree has already conducted studies on istaroxime in Chinese heart failure patients, with positive results from a Phase 2b study. Lee’s plans to initiate Phase 3 trials for istaroxime in acute heart failure, while Windtree continues its global cardiogenic shock program.

Under the agreement, Lee’s obtains the license to develop and commercialize istaroxime, dual mechanism SERCA2a activators, and rostafuroxin in Greater China. Windtree stands to receive up to $138.1 million in milestone payments, with approximately $100 million linked to the heart failure assets, along with low double-digit royalties. Lee’s will be responsible for funding all aspects of development, manufacturing, regulatory, and commercialization costs in the licensed region. The financial support extends to all indications studied in the region, including global clinical trials. Joint steering and development committees will oversee regional development, with Windtree retaining final decision rights over clinical protocols. Additionally, a joint commercialization committee is established.

Istaroxime, a first-in-class dual-mechanism therapy, aims to enhance both systolic and diastolic cardiac function. It acts as a positive inotropic agent, increasing myocardial contractility, and facilitates myocardial relaxation through activation of the SERCA2a calcium pump. Multiple Phase 2 studies have shown significant improvement in cardiac function and blood pressure without adverse effects on heart rate or cardiac rhythm in patients with early cardiogenic shock or acute decompensated heart failure.

Windtree's research program on dual mechanism SERCA2a activators is focused on evaluating preclinical candidates in heart failure. Rostafuroxin, a novel candidate, targets hypertension in patients with specific genetic profiles.

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