Verona Pharma plc (Nasdaq: VRNA) announced a successful start to the U.S. launch of Ohtuvayre™ (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disease (COPD), reporting $5.6 million in net sales for the third quarter of 2024. October sales have already surpassed the entire third quarter, indicating an accelerating adoption rate.
Strong Initial Uptake of Ohtuvayre™
According to David Zaccardelli, Pharm. D., President and Chief Executive Officer, Ohtuvayre™ is being prescribed across a broad spectrum of COPD patients, including those on single, dual, and triple therapies. "We are extremely encouraged from the initial patient and HCP reports about Ohtuvayre’s potential to improve COPD symptoms regardless of COPD severity," said Zaccardelli. Within the first 12 weeks, more than 5,000 prescriptions were filled by over 2,200 unique healthcare professionals.
Expanding Clinical Programs
Verona Pharma is also advancing its pipeline with two Phase 2 clinical trials. One trial is evaluating a dose-ranging regimen of glycopyrrolate, a long-acting muscarinic antagonist (LAMA), in combination with ensifentrine for COPD maintenance therapy, administered via nebulizer. The second trial is assessing the efficacy and safety of nebulized ensifentrine in patients with non-cystic fibrosis bronchiectasis (NCFBE).
Financial Highlights
The company's financial position remains strong, with $336.0 million in cash and cash equivalents as of September 30, 2024. Verona Pharma believes its current cash reserves, combined with anticipated product sales and funding from strategic financings, will sustain operations through at least the end of 2026. Cost of sales for the third quarter were $0.5 million, including manufacturing costs and royalties. Research and development expenses increased to $10.6 million, driven by the initiation of the Phase 2 trials. Selling, general, and administrative expenses rose to $35.2 million, reflecting commercial launch activities.
Additional Highlights
- Ohtuvayre™ received a permanent, product-specific J-code (J7601) from the Centers for Medicare & Medicaid Services, effective January 1, 2025.
- Nuance Pharma, Verona Pharma’s development partner in Greater China, completed enrollment in a pivotal Phase 3 trial evaluating ensifentrine for COPD maintenance treatment in China, with results expected in 2025.
Verona Pharma's strategic focus remains on developing and commercializing therapies for respiratory diseases with unmet needs. The company's lead product, Ohtuvayre™, represents a novel approach, combining bronchodilator and non-steroidal anti-inflammatory activities in a single molecule.
