The world’s largest acute heart failure patient population is in Greater China, where drug treatment innovation is sorely needed. Windtree Therapeutics Inc. (WINT) has announced a promising move to address this unmet need with its new license agreement with Lee’s Pharmaceutical (HK) Ltd.
This alliance aims to develop and commercialize Windtree’s product candidate istaroxime for acute heart failure and cardiogenic shock in the Greater China region. Additionally, the agreement includes the licensing of Windtree’s preclinical next-generation dual mechanism SERCA2a activators and rostafuroxin, a phase 2 product candidate for hypertension associated with specific genotypes.
Windtree’s Pipeline Bolstered by the Deal and Non-Dilutive Development Resources Potential
The accord fortifies Windtree’s pipeline for treating acute heart failure and cardiogenic shock and holds the potential to provide crucial financial backing for addressing the growing problem in China.
Craig Fraser, Windtree’s Chief Executive Officer, expressed confidence in the potential of Windtree’s pipeline and the positive impact of the license agreement. The deal serves as validation of the significant heart failure market opportunity for istaroxime and underscores the potential for the product to bring meaningful benefit to heart failure and cardiogenic shock patients.
Lee’s will obtain a license to develop and commercialize istaroxime, the dual mechanism SERCA2a activators, and rostafuroxin in the Greater China region. Windtree stands to receive up to $138.1 million in payments upon the achievement of certain milestones (approximately $100 million of which relate to the heart failure platform of assets) plus up to low double-digit royalties.
The financial agreement places the responsibility for funding all development, manufacturing, regulatory, and commercial costs for the covered products in the licensed region squarely on Lee’s shoulders. Moreover, it will extend to all indications studied in the region, including the portion of global clinical trials, such as the cardiogenic shock trial, which takes place in the licensed region. The agreement also establishes joint steering, development, and commercialization committees.
Innovative Solutions with Dual Mechanisms
Windtree’s istaroxime is a remarkable first-in-class, dual-action agent in clinical development for the treatment of acute decompensated heart failure (ADHF) and cardiogenic shock. This innovative drug intensifies the force of the heart’s contraction with each beat and enhances cardiac relaxation in between heartbeats.
The company aims to develop several products that can activate SERCA2a in novel manners, with istaroxime being the all-important first approach backed by positive clinical data. Windtree also has potential follow-on dual mechanism SERCA2a activator drug candidates in preclinical development. The goal is to create one or more dual mechanism SERCA2a activators, indicated for acute heart failure patients in the hospital, as well as an oral formulation for chronic heart failure patients in the outpatient setting.
Image sourced from Shutterstock
This post contains sponsored content. This content is for informational purposes only and not intended to be investing advice.
