FDA Approves Verona Pharma's Ohtuvayre™ for COPD Maintenance

Ligand Pharmaceuticals Inc. has announced that its partner, Verona Pharma plc, has gained approval from the U.S. Food and Drug Administration (FDA) for Ohtuvayre (ensifentrine). Ohtuvayre stands out as the first inhaled treatment with a unique mechanism for chronic obstructive pulmonary disease (COPD) maintenance in over two decades. Ligand will receive a $5.8 million milestone payment due to this FDA approval and anticipates an additional $13.8 million upon the commercial launch expected in the third quarter of 2024. Furthermore, Ligand is entitled to earn a low single-digit royalty on global net sales of Ohtuvayre.

Todd Davis, CEO of Ligand, expressed enthusiasm over this achievement, highlighting it as the second FDA approval within their royalty portfolio in a fortnight and the eighth regulatory approval since 2023. Davis emphasized the significant market potential for Ohtuvayre in the U.S. COPD market, which he believes will be a critical growth driver for Ligand.

Ohtuvayre is a pioneering drug that acts as a selective dual inhibitor of the enzymes phosphodiesterase 3 and 4 (PDE3 and PDE4), combining bronchodilator and anti-inflammatory properties in one molecule. It is administered directly to the lungs using a standard jet nebulizer, eliminating the need for high inspiratory flow or complex hand-breath coordination.

With this recent approval, Ligand's commercial stage portfolio now includes 11 key products, further supported by over 100 additional programs in various development stages.

Ohtuvayre has been rigorously evaluated in Verona's Phase 3 clinical program, ENHANCE, which focused on COPD maintenance treatment. The drug met primary endpoints in both ENHANCE-1 and ENHANCE-2 trials, showing significant and meaningful improvements in lung function. Verona is also developing a fixed-dose combination of ensifentrine and glycopyrrolate, a LAMA, for COPD maintenance. Ensifentrine may potentially be used to treat other respiratory conditions, including non-cystic fibrosis bronchiectasis, cystic fibrosis, and asthma.

COPD, a group of diseases causing airflow obstruction and breathing difficulties, affects over 390 million individuals worldwide, with 8.6 million Americans receiving chronic treatment. Common symptoms include heightened shortness of breath, frequent coughing, wheezing, chest tightness, and unusual fatigue. Approximately half of COPD patients endure daily symptoms. Despite existing treatments, COPD remains the third leading cause of death globally.

Ligand Pharmaceuticals is dedicated to advancing scientific breakthroughs by funding and supporting the clinical development of high-value medicines. They generate value for shareholders by fostering a diversified portfolio of biopharmaceutical product revenue streams, all supported by an efficient and low-cost corporate structure. Ligand’s strategy includes funding mid- to late-stage drug development programs in exchange for economic rights, purchasing royalty rights in development or commercial-stage biopharmaceutical products, and licensing technology to aid partners in drug discovery and development.

The company collaborates with pharmaceutical partners to leverage their late-stage development, regulatory management, and commercialization expertise to generate revenue. Ligand’s Captisol platform technology is a chemically modified cyclodextrin designed to enhance drug solubility and stability. Ligand’s partnerships include major biopharmaceutical companies such as Amgen, Merck, and Pfizer, among others.