Up To $138 Million in Milestones, Up To Low Double Digit Royalties: Windtree Announces Agreement To Develop And Commercialize Drug Candidates In Greater China

Greater China holds a significant, if not the world’s largest, acute heart failure patient population. It may be a market where drug treatment innovation can help patients and that’s what Windtree Therapeutics Inc. WINT is hoping to accomplish with its new license agreement with Lee’s Pharmaceutical (HK) Ltd. 

Windtree Therapeutics and Lee’s Pharmaceutical are teaming up to develop and commercialize Windtree’s product candidate istaroxime for acute heart failure and cardiogenic shock for the greater China region. In addition to istaroxime, the agreement also licenses 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 Supported With Deal As Company Also Potentially Gains Non-Dilutive Development Resources

The deal supports Windtree’s pipeline treatments for acute heart failure and cardiogenic shock and has the potential to provide financial support for development of treatment to address an unmet need and a growing problem in China. 

“We believe Windtree’s pipeline has great potential and we expect this license agreement will progress development in the treatment of heart failure. We see the agreement as validation of the significant heart failure market opportunity for istaroxime and, when coupled with the unique profile and our positive clinical results to date, demonstrates the potential for istaroxime to provide meaningful benefit in heart failure and cardiogenic shock patients. Greater China holds a significant, if not the largest, heart failure patient population. Windtree already studied istaroxime in heart failure patients in China and the results of the Company’s positive Phase 2b study have been presented and published. Lee’s intends to start Phase 3 for istaroxime in acute heart failure while Windtree continues to advance its global cardiogenic shock program,” said Craig Fraser, Windtree’s Chief Executive Officer. “Importantly, the agreement also provides support for development of one or more fast follow-on products from our next generation dual mechanism SERCA2a activators that have potential for oral formulation for treatment of chronic heart failure.”  

Lee’s will receive a license to develop and commercialize istaroxime, the dual mechanism SERCA2a activators and rostafuroxin in the greater China region for which Windtree is entitled 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. Lee’s will be responsible for funding all development, manufacturing, regulatory and commercial costs for the covered products in the licensed region. This financial support will apply to all indications studied in the region as well as the portion of global clinical trials, such as the cardiogenic shock trial, which take place in the licensed region. The agreement also establishes a joint steering committee and a joint development committee to oversee the regional development (with Windtree retaining final decision rights over clinical protocols) and a joint commercialization committee. 

Dual Mechanisms In One Drug

Windtree’s istaroxime is a first-in-class, dual-action agent in clinical development for the treatment of acute decompensated heart failure (ADHF) and cardiogenic shock. It increases the force of the heart’s contraction with each beat and improves cardiac relaxation in between heart beats. Windtree’s data from three phase 2 studies demonstrates that istaroxime both significantly improves cardiac function of a failing heart and blood pressure without increasing heart rate or the incidence of cardiac rhythm disturbances in acute heart failure and cardiogenic shock. 

One of the company’s goals is to develop several products that can activate SERCA2a in novel manners. Istaroxime represents an important first approach with building positive clinical data. Windtree also has potential follow-on dual mechanism SERCA2a activator drug candidates that are in preclinical development. The idea is to develop one or more dual mechanism SERCA2a activators that are indicated for use in acute heart failure patients in the hospital as well as an oral formulation indicated for use in chronic heart failure patients in the outpatient setting.

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