Windtree Therapeutics and Lee’s Pharmaceutical have signed a licence agreement to develop and market the former’s istaroxime for acute heart failure and cardiogenic shock in Greater China.

Lee’s will also gain rights for Windtree’s preclinical next-generation sarco/endoplasmic reticulum Ca2+ATPase (SERCA2a) activators and a Phase II hypertension drug, rostafuroxin.

Windtree will receive $138.1m in milestone payments and royalty payments on product sales.

Almost $100m is earmarked for the assets to treat heart failure.

Lee’s Pharmaceutical will fund the complete development, production regulatory and commercial expenditure linked to the products in the licensed territory.

The funding will cover all indications analysed within Greater China and the regional portion of global clinical trials, including those for cardiogenic shock.

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Joint committees will be established to oversee the development and commercialisation of the assets, with Windtree holding final decision rights for clinical protocols.

A dual-mechanism therapy, istaroxime has shown promise in boosting systolic and diastolic cardiac function. In multiple Phase II trials, it has enhanced cardiac output without raising heart rate or causing cardiac rhythm disturbances.

Rostafuroxin is intended to treat hypertension in people with specific genetic markers, offering a new approach.

Windtree Therapeutics CEO Craig Fraser stated: “We believe Windtree’s pipeline has great potential, and we expect this licence agreement will progress development in the treatment of heart failure.

“Lee’s intends to start Phase II for istaroxime in acute heart failure while Windtree continues to advance its global cardiogenic shock programme.

“Importantly, the agreement also provides support for the development of one or more fast follow-on products from our next-generation dual mechanism SERCA2a activators that have the potential for oral formulation for the treatment of chronic heart failure.”