A much-anticipated new potential drug for COPD moved a step closer to the market after Verona Pharma submitted its New Drug Application to the U.S. FDA, seeking approval of ensifentrine as a maintenance therapy. In the latest episode of Optimum Perspectives podcast, Eva Haas caught up with Chris Martin, Senior Vice President of Commercial, who discussed how the company plans to launch this potential novel COPD medicine.
Ensifentrine, if approved, could be the first new therapy for COPD in more than a decade and has been shown to improve lung function and reduce risks of exacerbations in two phase III trials.
With the FDA likely to make a decision on ensifentrine in the first half of 2024, Verona is gearing up for the next stage in the company’s development as it prepares for a potential launch following FDA approval.
A first-in-class, inhaled, dual non-steroidal inhibitor of the phosphodiesterase 3 (PDE3) and phosphodiesterase 4 (PDE4), ensifentrine combines bronchodilator and anti-inflammatory properties in one compound, differentiating it from other drugs used to treat COPD.
Data from the Phase III ENHANCE-1 and ENHANCE-2 clinical trials showed ensifentrine improved lung function and reduced the risks of exacerbations, which lead to poorer patient outcomes and are costly for healthcare systems due to unplanned hospital visits.
Verona plans to build a sales force to support launch, with around 100 representatives needed to cover the U.S. and around 12-13,000 healthcare providers.
According to Martin, Verona can compete with some of the large pharma companies in respiratory diseases because this sales force will be efficient, using the latest techniques, such as omnichannel marketing to communicate with physicians and patients.
“COVID has taught us that deploying a representative should not only be face to face, but also virtually, like we do every day with our meetings. Physicians are more than likely to be willing to meet with us in virtual and live environments.”
Martin also addressed the issue of potential competition from biologic drugs such as Sanofi’s Dupixent, which is already approved to treat asthma.
These are likely to be restricted to the sickest COPD patients, who have had multiple exacerbations and are not responding to other drugs.
Compare this with ensifentrine, which could potentially treat a broad section of the population with COPD, which affects around 12.5 million people in the U.S. alone according to the American Lung Association.
Going forward, the company has the financial capacity to market the drug, with around $270 million in cash and a debt facility of around $130 million to bankroll the launch.
That is enough to get the company through commercialization and to at least the end of 2025.
“It allows us to fund commercial and precommercial opportunities that are needed to ensure ensifentrine is successful,” Martin said.
To listen to the full interview or to discover past episodes of Optimum Perspectives Podcast, just click the link.
Available on all major players; Spotify, Apple Podcast, Amazon, Google and more… You can follow the show at wherever you get your podcast fix to stay up to date as episodes release!