Nuance Pharma Announces Approval of Ohtuvayre™ (ensifentrine) in Macau SAR, China

Ohtuvayre™is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients

First inhaled COPD treatment providing bronchodilation and non-steroidal anti-inflammatory effects

SHANGHAI, Feb. 7, 2025 /PRNewswire/ -- Today, Nuance Pharma ("Nuance") announced that the Pharmaceutical Administration Bureau Macau approved Ohtuvayre™ (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients.

In June 2024, Ohtuvayre™ was approved in the United States and became commercially available in August. Ohtuvayre™ is a first-in-class selective dual inhibitor of phosphodiesterase 3 and 4 ("PDE3; PDE4") that combines bronchodilator and non-steroidal anti-inflammatory effects in one molecule, delivered directly to the lungs through a standard jet nebulizer without the need for high inspiratory flow rates or complex hand-breath coordination.

The approval of Ohtuvayre™ in Macau SAR, China, was based on extensive data including the Global Phase 3 ENHANCE trials, the results of which were published in the American Journal of Respiratory and Critical Care Medicine. In the ENHANCE trials, Ohtuvayre^TM demonstrated clinical benefits both alone and when used with other maintenance therapies. Ohtuvayre^TM was well-tolerated in a broad population of subjects with moderate to severe COPD.

Mark Lotter, founder and Chief Executive Officer of Nuance Pharma, said: "We are pleased to announce that the Macau regulatory authority has approved the NDA of Ohtuvayre™, which also marks the first regulatory approval outside of the US. We are proud to provide access to this highly innovative COPD treatment to patients in Macau and beyond, for example through innovative policy in the Greater Bay Area (GBA). Respiratory disease is among Nuance's core areas of focus, and through approval in Macao SAR and early access programs in Hainan BoAo and GBA, Nuance Pharma is looking forward to providing this novel, first-in-class treatment to patients in China, prior to our expected NDA submission in 2025 upon completion of the ENHANCE-CHINA trial."

David Zaccardelli, Pharm. D., President and Chief Executive Officer of Verona Pharma, said: "We are very pleased that Ohtuvayre^TM is available to help patients still experiencing daily COPD symptoms. We are encouraged by the initial impact of Ohtuvayre^TM and believe its novel profile can re-define the COPD treatment paradigm."

In Nov 2024, Nuance Pharma launched Ohtuvayre™ in China's Hainan Boao Pilot Zone through early access program. In Sep 2024, Nuance Pharma completed recruitment for ENHANCE-CHINA, the phase 3 clinical trial of ensifentrine for the maintenance treatment of COPD.

In 2021, Nuance Pharma entered into an agreement with Verona Pharma for the exclusive rights to develop and commercialize Ohtuvayre™ in Greater China (mainland China, Hong Kong, Macau and Taiwan).

About Ohtuvayre™ (ensifentrine)

Ohtuvayre™ is the first inhaled therapy for the maintenance treatment of COPD that combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule. Verona has evaluated nebulized Ohtuvayre™ in its Phase 3 clinical program ENHANCE ("Ensifentrine as a Novel inHAled Nebulized COPD thErapy") for COPD maintenance treatment. Ohtuvayre™ met the primary endpoint in both ENHANCE-1 and ENHANCE-2, demonstrating statistically significant and clinically meaningful improvements in lung function.

About Verona Pharma

Verona Pharma is a biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of chronic respiratory diseases with significant unmet medical needs. Ohtuvayre^TM (ensifentrine) is the Company's first commercial product and the first inhaled therapy for the maintenance treatment of COPD that combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule. Ensifentrine has potential applications in non-cystic fibrosis bronchiectasis, 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.

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