With a target date for FDA approval less than a month away, Sanofi and Regeneron’s megablockbuster Dupixent has gained much attention as it is on the verge of becoming the first biologic to treat chronic obstructive pulmonary disorder (COPD).
Coming in under the radar with its own formidable COPD candidate is London-based Verona Pharmaceuticals. Ensifentrine—which has a PDUFA date of June 26, one day ahead of that for Dupixent—might be poised to upstage its powerhouse rival in the indication, according to positive reports from two industry think tanks on Thursday.
Based on data Verona presented earlier this month at the American Thoracic Society (ATS) international conference, GlobalData has called ensifentrine a “paradigm shift in COPD treatment.”
Additionally, GlobalData said that interviews with key opinion leaders (KOLs) have “expressed positive opinions on the candidate drug,” with one KOL adding that nebulized ensifentrine would have an uptake advantage because most COPD patients already are familiar with that form of administration as opposed to a biologic, which would be new to the indication.
Other KOLs expressed their “excitement” for ensifentrine as a first-in-class drug, GlobalData reported, with one KOL adding: “We can’t underestimate the value of novel targets.”
Meanwhile, the Institute for Clinical Economic Review (ICER), which assesses the value of pharmaceutical products, has estimated (PDF) in a revised evidence report that ensifentrine would meet commonly used cost-effectiveness thresholds at an annual price between $7,500 and $12,700 per year.
“Current evidence shows that ensifentrine decreases exacerbations when used in combination with some current inhaled therapies and is well-tolerated by patients, but there are uncertainties about how much benefit it may add to unstudied combinations of inhaled treatments,” David Rind, M.D., ICER’s chief medical officer, said in a release.
As a dual inhibitor of the phosphodiesterase 3 (PDE3) and phosphodiesterase 4 (PDE4) enzymes, ensifentrine combines bronchodilator and non-steroidal anti-inflammatory properties in one compound, Verona says, differentiating it from existing drug classes used to treat COPD.
“It’s really the first novel mechanism as an inhaled therapy in over 20 years for COPD,” David Zaccardelli, Verona’s CEO said in a recent interview with Fierce Pharma.
Verona has not said what it will charge for the treatment. Assuming it is approved, the company plans to launch ensifentrine in the third quarter of this year, it said at ATS. GlobalData previously estimated its sales will reach $1.05 billion by 2029.
It is set to become the first commercial product for the 19-year-old company, which was established based on the potential of ensifentrine to treat COPD and other respiratory disorders.
Promise of the launch has allowed Verona to secure a financing deal of up to $650 million on top of its existing cash of $255 million as of the end of the first quarter. The company has a runway “beyond 2026,” Zaccardelli said during its quarterly presentation three weeks ago.
Meanwhile, Dupixent’s approval in COPD could be delayed. Earlier this month, Regeneron said that the FDA had requested additional sub-population data from two trials that have set Dupixent up for approval in what would be its seventh indication.