Breakthrough Clinical Results
Merck has agreed to acquire Verona Pharma for approximately $10 billion. This acquisition brings Ohtuvayre (ensifentrine), a first-in-class COPD maintenance treatment, into Merck's portfolio. Ohtuvayre is a dual inhibitor of PDE3 and PDE4, offering both bronchodilator and non-steroidal anti-inflammatory effects. The FDA approved Ohtuvayre in June 2024, and it's currently being evaluated in clinical trials for non-cystic fibrosis bronchiectasis. The acquisition is expected to close in the fourth quarter of 2025 and is expected to drive significant growth for Merck in the cardio-pulmonary disease space.
Key Highlights
- Merck acquires Verona Pharma for ~$10 billion.
- Acquisition includes Ohtuvayre (ensifentrine), a first-in-class COPD treatment.
- Ohtuvayre offers dual bronchodilator and anti-inflammatory effects.
- Transaction expected to close in Q4 2025.
Incidence and Prevalence
Global Epidemiology of Chronic Obstructive Pulmonary Disease (COPD)
Global Prevalence
According to a worldwide study that included participants from 12 sites (n=9425), the prevalence of stage II or higher COPD was 10.1% (SE 4.8) overall, with 11.8% (7.9) for men and 8.5% (5.8) for women. This study showed higher levels and more advanced staging of spirometrically confirmed COPD than have typically been reported.
Prevalence rates of COPD range from 4.5% to 11% in developed countries of Europe and the USA. In specific countries:
- In Finland, the prevalence was between 5.4% and 9.4% according to criteria from different organizations
- In France, chronic bronchitis prevalence was estimated at 4%, with COPD prevalence at 5-10% among adults aged 45 years and older
- In the Czech Republic, COPD prevalence is 7.7%
- In rural southwest China, prevalence increased from 8.7% to 12.8% from 2011 to 2021
- In Bangladesh, the pooled COPD prevalence among adults was 12.5% (95% CI, 10.9-14.1) using GOLD criteria and 11.9% (95% CI, 11.4-13.6) using LLN criteria
- In Samara (a big industrial city of Middle Volga), COPD was found in 14.49% among 2063 examined people
Demographic Distribution
The available data suggests significant variation in COPD prevalence across different regions and populations. COPD prevalence is generally higher in men, ethnic minorities, and those with lower socioeconomic status.
In Bangladesh, COPD prevalence was higher among males, low socio-economic groups, rural residents, and biomass fuel users.
Age distribution data from Samara showed COPD prevalence of: - 30-39 years: 10.76% - 40-49 years: 10.89% - 50-59 years: 15.88% - 60 years and upward: 21.30%
Gender distribution in the same study showed COPD in 18.72% among 903 examined men and in 11.21% among 1160 examined women.
Risk Factors
Age and smoking are strong contributors to COPD, but they do not fully explain variations in disease prevalence—other factors also seem to be important.
The odds ratios for 10-year age increments were much the same across sites and for women and men, with an overall pooled estimate of 1.94 (95% CI 1.80-2.10) per 10-year increment.
Site-specific pack-year odds ratios varied significantly in women (pooled OR=1.28, 95% CI 1.15-1.42, p=0.012), but not in men (1.16, 1.12-1.21, p=0.743). Among subjects with a smoking history of more than 40 pack-years, the prevalence of COPD was over 50%.
Other leading risk factors identified include tobacco consumption, exposure to biomass fuel, old age, history of asthma, ecology, genetic predisposition, level of education, and marriage status. Traffic-related air pollution is also positively associated with COPD prevalence.
Global Burden and Mortality
COPD is a leading cause of mortality worldwide, described as the fourth leading cause of death with an estimated 2.75 million deaths in 2000. Some studies note that COPD ranks as the third leading global cause of mortality.
According to WHO predictions, COPD will become the third leading cause of mortality and the fifth cause of disability worldwide by 2020. COPD is currently the fifth leading cause of mortality among all diseases globally.
In the Czech Republic, mortality rates for COPD (2001) were: men 21.3/100,000 inhabitants, women 11.6/100,000, totaling 1,666 deaths. In the USA, 119,000 inhabitants died from COPD in 2001.
The DALY (Disability-Adjusted Life Year) system shows COPD moving from 12th to 5th position in developed countries.
Drug used in other indications
Ensifentrine (Ohtuvayre) Clinical Trials Beyond COPD
After carefully reviewing all available information, I cannot find any data about ensifentrine (Ohtuvayre, RPL554) undergoing clinical trials for indications beyond COPD, such as asthma, cystic fibrosis, or bronchiectasis.
The available information only relates to ensifentrine's use in COPD treatment, with no details about trials for other indications or their associated intervention models, dosing regimens, administration routes, or study designs.