Verona gets EU patent for ensifentrine formulation extended to 2035

Drug by the British company is in Phase 2b clinical trials for chronic obstructive pulmonary disease

The European Patent Office has granted Verona Pharma an additional key patent relating to its lead development candidate, ensifentrine. The patent provides intellectual property protection throughout Europe up to 2035 for a suspension formulation of ensifentrine (RPL554) suitable for nebulised administration. A corresponding patent has already issued in the US.

Ensifentrine is in Phase 2b clinical trials for chronic obstructive pulmonary disease (COPD). This first-in-class inhaled therapy has both bronchodilator and anti-inflammatory activity in a single agent and has the potential to address a major unmet need in COPD.

“The granting of this important patent adds a further layer of protection to ensifentrine as a novel potential treatment for COPD,” said Jan-Anders Karlsson, Verona Pharma CEO.

Karlsson said the company remains focused on completing the final Phase 2b clinical trials with ensifentrine before advancing into Phase 3 in 2020.

He explained: "Ensifentrine has been administered to over 800 people and has generated strong efficacy data and been well tolerated. We believe this first-in-class dual PD3 and PD4 inhibitor can address a clear unmet medical need in COPD and has significant commercial potential.”

For Verona, this patent further strengthens its intellectual property estate, which provides exclusivity for ensifentrine products in key markets such as the US and Europe up to 2035.

Currently, the patent estate includes eight issued US patents and seven European patents, which have been validated in a wide range of countries throughout Europe, as well as patents in other commercially important jurisdictions such as China and Japan.

These patents cover a range of subject matter including formulations, solid forms and methods of using ensifentrine for the treatment of respiratory disorders.

In addition to the granted patents, over 50 applications are pending, and, if granted, could potentially extend the patent protection even further.

Patent protected

European patent EP3332767, B entitled “Liquid Inhalation Formulation Comprising RPL554,” was granted in March 2019 and provides protection throughout Europe for a suspension formulation of ensifentrine suitable for nebulised administration with an expiry date in September 2035. US patent US 9,956,171 B, issued in May 2018, provides protection in the US for a related suspension formulation and also has an expiry date in September 2035.

COPD is a progressive and life-threatening respiratory disease without a cure. The World Health Organization estimates that it will become the third leading cause of death worldwide by 2030.

The condition damages the airways and the lungs, leading to debilitating breathlessness that has a devastating impact on performing basic daily activities such as walking, bending and carrying.

In the United States alone, the 2010 total annual medical costs related to COPD were estimated to be $32 billion and are projected to rise to $49 billion in 2020. About 800,000 US COPD patients on dual/triple inhaled therapy (ICS/LAMA/LABA) remain uncontrolled. These patients urgently need drugs with novel mechanisms of action that can be used in addition to current therapies.

Verona Pharma is developing ensifentrine for the treatment of COPD, cystic fibrosis, and asthma.

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