Nuance Pharma's Partner Verona Pharma Submits New Drug Application to US FDA for Ensifentrine for the Maintenance Treatment of COPD

SHANGHAI, June 28, 2023 /PRNewswire/ -- Nuance Pharma announces its partner, Verona Pharma plc (Nasdaq: VRNA),  has submitted a New Drug Application ("NDA") to the US Food and Drug Administration ("FDA") for approval of ensifentrine for the maintenance treatment of patients with chronic obstructive pulmonary disease ("COPD").

Ensifentrine is a selective dual inhibitor of the enzymes phosphodiesterase 3 and 4 combining bronchodilator and non-steroidal anti-inflammatory activities in one molecule. If approved, it is expected to be the first novel mechanism available for the treatment of COPD in over 10 years.

Mr. Mark Lotter, founder and CEO of Nuance Pharma, commented: "We are immensely proud to see ensifentrine's progress with the FDA. This exciting milestone affirmed our confidence in ensifentrine's potential to re-define the COPD treatment globally. Like our partner Verona, we are highly committed to bringing this first-in-class therapy to patients in Greater China. Together, we aim to significantly improve the lives of millions coping with this challenging disease."

"Millions of symptomatic COPD patients in the US are in urgent need of new treatment options," said David Zaccardelli, Pharm. D., President and Chief Executive Officer of Verona Pharma. "The NDA submission for ensifentrine is a significant milestone towards our goal of bringing this potential first-in-class therapy to COPD patients and we look forward to working with the FDA during their review." The NDA contains data from the positive Phase 3 ENHANCE studies and other ensifentrine clinical studies including data from approximately 3,000 subjects.

In 2021, Nuance Pharma entered into an agreement with Verona Pharma for the exclusive rights to develop and commercialize ensifentrine in Greater China. On April 6th 2023, Nuance Pharma announced first patient in (FPI) for the ENHANCE-China Phase III clinical trial.

About Ensifentrine

Ensifentrine (RPL554) is a selective dual inhibitor of the enzymes phosphodiesterase 3 and 4 that combines bronchodilator and anti-inflammatory activities in one compound. In Phase 2 clinical studies in COPD, ensifentrine has shown significant and clinically meaningful improvements in lung function, symptoms and quality of life as a monotherapy or added onto a maintenance bronchodilator. In the Phase 3 ENHANCE-1 and ENHANCE-2 clinical trials, ensifentrine showed significant and clinically meaningful improvements in lung function measures and reduced the rate of COPD exacerbations. Ensifentrine has been well tolerated in clinical trials involving approximately 3,000 subjects to date.

About Verona Pharma

Verona Pharma is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of chronic respiratory diseases with significant unmet medical needs. If successfully developed and approved, Verona Pharma's product candidate, ensifentrine, has the potential to be the first non-steroidal therapy for the treatment of respiratory diseases that combines bronchodilator and anti-inflammatory activities in one compound. Ensifentrine met the primary endpoint in its Phase III trial, demonstrating statistically significant and clinically meaningful improvements in lung function and substantially reduced the rate and risk of COPD exacerbations. Two additional formulations of ensifentrine have been evaluated in Phase 2 studies for the treatment of COPD: dry powder inhaler ("DPI") and pressurized metered-dose inhaler ("pMDI"). Ensifentrine has potential applications in cystic fibrosis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com.

About Nuance pharma

Nuance Pharma is an innovation focused biopharmaceutical company, with both late-stage clinical pipeline and commercial stage asset portfolio. Focusing on specialty care, Nuance has established a differentiated combination of commercialized assets and innovative pipeline across respiratory, pain management, emergency care and iron deficiency anemia.

With the mission to address critical unmet medical needs in Asia Pacific, Nuance deploys the Dual Wheel model that develops a global leading innovative pipeline, while maintaining a self-sustainable commercial operation in both China and Asia as a region. For more information, please visit www.nuancepharma.com.

Forward-looking statements

This announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of our control, that could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning our plans, objectives, goals, future events, performance and/or other information that is not historical information. All such forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements which may accompany the forward-looking statements. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law.

SOURCE Nuance Pharma Limited