RESEARCH TRIANGLE PARK – Verona Pharma has clinched a $219 million deal to market its “first-in-class” drug, ensifentrine, targeting chronic obstructive pulmonary disease (COPD), in China.
This week, the British clinical-stage biotech firm with U.S. headquarters in Raleigh announced it has entered into an agreement granting Nuance Pharma, a Shanghai-based specialty pharmaceutical company, the rights to develop and commercialize ensifentrine in Greater China. That includes mainland China, Taiwan, Hong Kong and Macau.
“We are extremely excited about the formation of this strategic partnership with Nuance Pharma to further the development and future commercialization of ensifentrine in Greater China,” said David Zaccardelli, president and CEO of Verona Pharma.
“Nuance Pharma’s highly talented leadership team has deep experience developing and commercializing respiratory products across China and we look forward to working with them to bring ensifentrine to this important market.”
As part of the deal, Verona Pharma will receive an upfront payment of $25 million in cash and an equity interest currently valued at $15 million in Nuance Biotech, the parent company of Nuance Pharma.
Verona Pharma is also eligible to receive future milestone payments of up to $179 million that are triggered upon achievement of certain clinical, regulatory, and commercial milestones – as well as tiered double-digit royalties as a percentage of net sales in China.
Ensifentrine is an investigational, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 (“PDE3” and “PDE4”). This dual inhibition enables it to combine both bronchodilator and anti-inflammatory effects in one compound.
Ensifentrine (formerly called RPL554) was selected from a class of compounds co-invented by Sir David Jack, the former GlaxoSmithKline research director who pioneered many of the leading respiratory drugs already in use (salbutamol/albuterol (Ventolin), salmeterol and fluticasone), and Alexander Oxford, a medicinal chemist.
Verona acquired the drug in 2006.
The company now has its clinical team of about 10 women based in North Carolina, most of them ex-GlaxoSmithKline employees, working with Raleigh-based global contract organization IQVIA to carry out the Phase 3 trials, which consist of two international studies.
Each is expected to enroll about 800 patients at 100 sites, mostly in the U.S., Europe and other countries, including South Korea.
Verona Pharma is currently conducting a global Phase 3 program evaluating ensifentrine for the maintenance treatment of COPD, with sites in the U.S., Europe and South Korea.
It also has potential applications in cystic fibrosis, asthma and other respiratory diseases.
“Ensifentrine is an ideal fit for Nuance Pharma’s portfolio,” said Mark Lotter, CEO and co-founder of Nuance. “With proven expertise in developing and commercializing global brands, including many leading respiratory products, I have confidence in the Nuance Pharma team’s ability to develop and commercialize ensifentrine in Greater China.”
A potential COVID-19 treatment?
Separately, Verona Pharma recently completed a pilot clinical trial using its leading drug candidate to treat COVID-19 patients.
The randomized double-blind, placebo-controlled study tested ensifentrine delivered through a pressurized metered-dose inhaler on hospitalized COVID-19 patients at the University of Alabama at Birmingham.
“Overall, the patients in this study recovered exceptionally well, as the mortality rate in the study was much lower than aggregate data from the hospital would have suggested over the same time period,” said Dr. Mike Wells, a pulmonologist and principal investigator at the University of Alabama at Birmingham Hospital.
Verona Pharma said the trial was not designed or sized to demonstrate clinical efficacy and no clinical efficacy benefit with ensifentrine treatment added on to standard of care was observed in the trial.
One patient death was reported in the ensifentrine treatment group.
“We remain focused on our ongoing Phase 3 trial in COPD and do not currently plan to conduct further studies of ensifentrine in the treatment of COVID-19,” a spokesperson told North Carolina Biotechnology Center.