Windtree Therapeutics Strikes Landmark Deal with Lee’s Pharmaceutical for Heart Failure Treatments

Windtree Therapeutics

WARRINGTON, PA — Windtree Therapeutics, Inc. (NasdaqCM: WINT) has announced a significant license agreement with Lee’s Pharmaceutical (HK) Limited (“Lee’s”), a leading Hong Kong-based pharmaceutical company. The deal involves the development and commercialization of Windtree’s product candidate istaroxime, a promising treatment for acute heart failure and cardiogenic shock, in Greater China.

Industry observers view the agreement as a significant step forward in the development of heart failure treatments. The deal goes beyond istaroxime, also licensing Windtree’s preclinical next-generation SERCA2a activators, known as dual mechanism SERCA2a activators, and rostafuroxin, a Phase 2 product candidate for hypertension associated with specific genotypes.

Craig Fraser, Windtree’s Chief Executive Officer, expressed optimism about the deal, citing it as validation of the substantial heart failure market opportunity for istaroxime. He highlighted the significant heart failure patient population in Greater China and pointed to positive results from the company’s Phase 2b study of istaroxime in heart failure patients in the region.

“This agreement demonstrates the potential for istaroxime to provide meaningful benefit in heart failure and cardiogenic shock patients,” said Fraser. “It also provides support for the development of one or more products from our next-generation dual mechanism SERCA2a activators that have potential for oral formulation for treatment of chronic heart failure.”

The financial terms of the agreement could see Windtree receive up to $138.1 million in payments upon achieving certain milestones. Approximately $100 million of this sum is tied to the heart failure platform of assets, and Windtree is also set to receive up to low double-digit royalties. Lee’s will shoulder all costs related to development, manufacturing, regulatory issues, and commercialization for the covered products in the licensed region.

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This agreement could have significant implications for investors and industry watchers. It demonstrates Windtree’s commitment to advancing its global cardiogenic shock program and expanding its footprint in Greater China, a region with a substantial heart failure patient population. Moreover, it provides further validation of the company’s heart failure treatments and their potential market opportunities.

The Windtree-Lee’s partnership establishes a joint steering committee and a joint development committee to oversee regional development, with Windtree retaining final decision rights over clinical protocols. A joint commercialization committee is also part of the agreement. The deal, thus, represents a strategic alliance that could significantly accelerate the development and commercialization of next-generation heart failure treatments.

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