Windtree Therapeutics said that it has signed a deal with Lee’s Pharmaceutical and its subsidiary Zhaoke Pharmaceutical giving Lee’s global rights to develop and commercialize Windtree surfactants for any potential indications, including Aerosurf aerosolized KL4 surfactant for the treatment of premature infants with respiratory distress syndrome. According to Windtree, the deal includes milestone payments worth up to $78.9 million as well as double-digit royalties on any future sales, and Lee’s will be responsible for all future costs related to development and commercialization of the surfactants.
Lee’s acquired Asian rights to Aerosurf in 2017 and acquired a controlling interest in Windtree shortly thereafter. Lee’s also provided funding for a Phase 2b study of Aerosurf in premature infants with RDS in 2020; an earlier Phase 2b clinical trial of Aerosurf in premature infants receiving nasal continuous positive airway pressure (nCPAP) had failed to meet its primary endpoint.
Windtree President and CEO Craig Fraser commented, “We are excited to announce this global licensing transaction for our KL4 surfactant platform given the value it can provide to the company, its shareholders and critically ill patients. . . . Given the clinical potential of KL4 surfactant and Aerosurf to help preterm infants with RDS, we desired a partner who was capable of fully assuming execution of the platform and could build value. Over the past few years, we have worked with the Lee’s and Zhaoke’s teams as they invested significantly in building manufacturing, analytical and clinical capabilities to move the KL4 platform into late-stage development. This transaction strengthens Windtree’s resources for its core programs and delivers significant potential value to its shareholders on assets we were no longer progressing ourselves.”
Aerosurf received Fast Track designation from the FDA in 2016. The surfactant is delivered via Windtree’s proprietary ADS (aerosol delivery system) platform.
Read the Windtree Therapeutics press release.
