Verona Pharma's Ohtuvayre™ (ensifentrine) has demonstrated a strong start in the market, generating $5.6 million in net sales during its initial seven weeks post-launch. The drug, approved for the maintenance treatment of chronic obstructive pulmonary disease (COPD), has shown promising early adoption, with October sales exceeding the entire third-quarter performance. This milestone indicates a positive reception from healthcare professionals and patients, suggesting a potential shift in the COPD treatment paradigm.
Commercial Launch and Market Penetration
According to Verona Pharma, more than 5,000 prescriptions for Ohtuvayre were filled, and over 2,200 unique healthcare providers prescribed the drug within the first 12 weeks. This broad utilization across various COPD patient segments, including those on single, dual, and triple therapy, underscores the drug's versatility as both a bronchodilator and non-steroidal anti-inflammatory agent. David Zaccardelli, Pharm. D., President and Chief Executive Officer, noted that these early reports suggest Ohtuvayre's potential to improve COPD symptoms regardless of disease severity.
Clinical Development and Pipeline Expansion
In addition to the successful launch of Ohtuvayre, Verona Pharma has initiated two Phase 2 clinical trials. One trial is evaluating a dose-ranging combination of ensifentrine with glycopyrrolate, a long-acting muscarinic antagonist (LAMA), to support a nebulized fixed-dose combination program for COPD maintenance therapy. The second trial is assessing the efficacy and safety of nebulized ensifentrine in patients with non-cystic fibrosis bronchiectasis (NCFBE), expanding the potential applications of the drug.
Financial Position and Outlook
Verona Pharma reported a solid financial position with $336.0 million in cash and cash equivalents as of September 30, 2024. The company believes these funds, along with product sales and expected funding from strategic financings, will be sufficient to support operations through at least the end of 2026. While operating expenses increased, with R&D at $10.6 million and SG&A at $35.2 million, the company's investments in commercial infrastructure and clinical development reflect its commitment to long-term growth.
Regulatory and Reimbursement Landscape
Verona Pharma has secured a permanent, product-specific J-code (J7601) for Ohtuvayre from the Centers for Medicare & Medicaid Services, effective January 1, 2025. This J-code is expected to streamline reimbursement processes and improve patient access to the drug. The company's development partner in Greater China, Nuance Pharma, has completed enrollment in a pivotal Phase 3 clinical trial evaluating ensifentrine for COPD maintenance treatment in China, with results anticipated in 2025.
