Verona wins FDA approval of ensifentrine for COPD; stock surges 20%

Verona wins FDA approval of ensifentrine for COPD; stock surges 20%

Verona Pharma, a leading biopharmaceutical company specializing in respiratory diseases, announced on [Date] that the US Food and Drug Administration (FDA) has granted approval for the launch of ensifentrine, its first-in-class dual phosphodiesterase (PDE) 3/4 inhibitor, in the US market for the treatment of chronic obstructive pulmonary disease (COPD) patients. This approval comes after two successful phase III clinical trials, ENHANCE-1 and ENHANCE-2, and data presented at the American Thoracic Society (ATS) conference in May 2024.

Ensifentrine is administered as a nebulized formulation and is designed to reduce exacerbations in COPD patients by targeting both PDE3 and PDE4 enzymes. According to data from the ENHANCE-1 and ENHANCE-2 trials, ensifentrine significantly reduced exacerbation rate and risk over 24 weeks in COPD patients, regardless of blood eosinophil levels, compared to a placebo. Furthermore, ensifentrine demonstrated improvements in dyspnea as early as 6 weeks, with significant differences seen in subgroups of eosinophils (100 and 300 cells/uL).

In preparation for this potential milestone, Verona Pharma has secured a financing deal of $650 million to support the US launch of ensifentrine. This financing, agreed upon with Oaktree Capital Management and OMERS Life Sciences, provides Verona with access to $400 million in term loans in five separate tranches and up to $250 million from the sale of redeemable interest in future revenue generated by the candidate drug. This funding will enable Verona to cover planned operating expenses and capital expenditures beyond 2026, including the drug's commercial launch in the US.

Moreover, data presented at the ATS 2024 conference showed that ensifentrine, when given alongside a long-acting muscarinic antagonist (LAMA) maintenance therapy consistently from Week 6 to Week 24, significantly improved symptoms and health-related quality of life compared to placebo. The combination of two optimistic agents to tackle symptoms and exacerbations as a fixed-dose product has significant potential in the post-approval stage of ensifentrine.

Verona Pharma intends to commercialize ensifentrine in the US and is finalizing preparations for the potential launch in the third quarter (Q3) of 2024, subject to FDA approval. The company's stock price surged by over 20% on the news of the FDA approval, reflecting the potential market demand for a new and effective COPD treatment option.

[1] Verona Pharma finalises preparations for potential US launch of ensifentrine in Q3 2024, https://www.pharmaceutical-technology.com/analyst-comment/verona-us-launch-ensifentrine-copd/