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Ligand Partner Verona Pharma Announces FDA Approval of Ohtuvayre™ (ensifentrine), First Inhaled Novel Mechanism for Maintenance Treatment of COPD in More Than 20 Years
FDA approval increases Ligand’s key commercial stage portfolio to 11 products Ligand is entitled to receive a low single-digit royalty on worldwide net sales
About this update from Ligand Pharmaceuticals Incorporated
[{"type":"text","content":"\nFDA approval increases Ligand’s key commercial stage portfolio to 11 products\n\n\nLigand is entitled to receive a low single-digit royalty on worldwide net sales of Ohtuvayre\n\n\n JUPITER, Fla.--(BUSINESS WIRE)--\nLigand Pharmaceuticals Incorporated (Nasdaq: LGND) today announced that its partner Verona Pharma plc has received approval from the U.S. Food and Drug Administration (FDA) for Ohtuvayre™ (ensifentrine). Ohtuvayre is the first inhaled product with a novel mechanism of action available for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients in more than 20 years. Ligand has earned a $5.8 million milestone payment upon FDA approval of Ohtuvayre and will earn an additional $13.8 million upon its commercial launch which is expected to occur during the third quarter of 2024. Ligand is entitled to a low single-digit royalty on worldwide net sales of Ohtuvayre.\n\n\n“Verona Pharma has worked tirelessly to bring a new treatment option to the millions of people managing chronic COPD and we are excited to see their efforts come to fruition with this approval,” said Todd Davis, CEO of Ligand. “For Ligand this is an important milestone, as it’s the second FDA approval within our royalty portfolio in two weeks and the eighth regulatory approval since 2023. COPD is a multi-billion-dollar market opportunity in the U.S. alone, and we believe Ohtuvayre will be another key growth driver for Ligand.”\n\n\nOhtuvayre is a first-in-class selective dual inhibitor of the enzymes phosphodiesterase 3 and phosphodiesterase 4 (“PDE3 and PDE4”) that combines bronchodilator and non-steroidal anti-inflammatory effects in one molecule. Ohtuvayre is delivered directly to the lungs through a standard jet nebulizer without the need for high inspiratory flow rates or complex hand-breath coordination.\n\n\nWith this FDA approval, Ligand now has 11 key commercial products driving the company’s financial performance and a portfolio of more than 100 additional programs at various stages of development.\n\n\nAbout OhtuvayreTM (ensifentrine)\n\n\nOhtuvayre 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 Nove...