US-based Windtree Therapeutics has signed a licence agreement with Hong Kong-based Lee’s Pharmaceutical to develop and commercialise Windtree’s istaroxime in Greater China, including for acute heart failure and cardiogenic shock.

Along with istaroxime, the agreement licences Windtree’s preclinical next-generation SERCA2a activators, called dual mechanism SERCA2a activators.

The deal also includes rostafuroxin, which is a Phase 2 product candidate for hypertension associated with specific genotypes.

Windtree is entitled to receive up to $138.1m in payments upon achievement of certain milestones and up to low double-digit royalties.

The Hong Kong-based firm will assume full financial responsibility for all development, production, regulatory, and promotional expenses for the covered items in the permitted region.

The funding will cover all indications researched in the area and the portion of international clinical studies conducted in the licenced region, including the cardiogenic shock trial.

In addition, the agreement creates a joint commercialisation committee, a joint development committee, and a joint steering group to manage regional development.

However, Windtree will maintain the final decision rights over clinical protocols.

Windtree CEO Craig Fraser said: “We believe Windtree’s pipeline has great potential and we expect this licence 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 programme.”