Verona Pharma has sold the rights to chronic obstructive pulmonary disease (COPD) drug candidate ensifentrine in greater China to Nuance Pharma for $40 million upfront. A nebulized formulation of the dual PDE3-PDE4 inhibitor is in phase 3 development as a maintenance treatment for COPD.
Shanghai-based Nuance is handing Verona $25 million in cash and $15 million in equity in return for the rights to develop and commercialize ensifentrine in mainland China, Taiwan, Hong Kong and Macau. Nuance, which is on the hook for up to $179 million in milestones and double-digit royalties, plans to file to trial ensifentrine in greater China this year and will fund all costs in the territory.
“With proven expertise in developing and commercializing global brands, including many leading respiratory products, I have confidence in the Nuance Pharma team’s ability to develop and commercialize ensifentrine in Greater China,” Nuance CEO Mark Lotter said in a statement.
The greater China development plan, which a joint steering committee will align with Verona’s global strategy, builds on years of work elsewhere. The late Glaxo researcher David Jack co-invented ensifentrine, also known as RPL554, but stability issues made the molecule commercially unviable.
Verona overcame the stability issues with a formulation consisting of suspended particles delivered via a nebulizer. Efforts to bring the nebulized formulation to market have hit setbacks, notably when a phase 2 COPD trial missed its primary endpoint, but Verona has generated enough signs of efficacy to take the candidate into a late-stage trial.
Work on the nebulized formulation is advancing in parallel to clinical trials of ensifentrine delivered using a dry powder inhaler and a pressurized metered-dose inhaler. Verona has phase 2 data on both formulations it said will expand opportunities including life-cycle management, new indications and partnering.