Bolsters patent estate for lead development candidate and provides expiry dates out to 2035
LONDON, April 09, 2019 (GLOBE NEWSWIRE) -- Verona Pharma plc (VRP.L) (VRNA) (“Verona Pharma”), a clinical stage biopharmaceutical company focused on respiratory diseases, is pleased to announce that the European Patent Office has recently granted an additional key patent relating to its lead development candidate, ensifentrine. The patent provides intellectual property protection throughout Europe out to 2035 for a suspension formulation of ensifentrine (RPL554) suitable for nebulized 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.
This patent further strengthens Verona Pharma’s intellectual property estate, which provides exclusivity for ensifentrine products in key markets such as the US and Europe out 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.
“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, PhD, CEO of Verona Pharma. “We remain focused on completing the final Phase 2b clinical trials with ensifentrine before advancing into Phase 3 in 2020. 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.”
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 nebulized 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.
About Chronic Obstructive Pulmonary Disease
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.
About Verona Pharma plc
Verona Pharma is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of respiratory diseases with significant unmet medical needs. The company’s product candidate, ensifentrine, is an investigational first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 which has been shown to act as both a bronchodilator and an anti-inflammatory in a single compound. In clinical trials, the nebulized formulation of ensifentrine has resulted in bronchodilator effects when used alone or as an add-on treatment to other COPD bronchodilators. Also, it has shown clinically meaningful and statistically significant improvements in lung function when administered in addition to frequently used short- and long-acting bronchodilators, such as tiotropium (Spiriva®), compared with such bronchodilators administered as a single agent. In addition, ensifentrine has shown anti-inflammatory effects in a standard challenge study with COPD-like inflammation in humans. Ensifentrine has been well tolerated in these studies, having been administered to more than 800 people in clinical trials. Verona Pharma is developing ensifentrine for the treatment of COPD, cystic fibrosis, and asthma.
This press release contains forward-looking statements. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding ensifentrine as a first-in-class inhibitor, ensifentrine’s potential to treat COPD and its commercial potential, the potential of unissued patents to extend patent protection, and estimates of the medical cost for COPD and projected increases.
These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from our expectations expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history; our need for additional funding to complete development and commercialization of ensifentrine, which may not be available and which may force us to delay, reduce or eliminate our development or commercialization efforts; the reliance of our business on the success of ensifentrine, our only product candidate under development; economic, political, regulatory and other risks involved with international operations; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; serious adverse, undesirable or unacceptable side effects associated with ensifentrine, which could adversely affect our ability to develop or commercialize ensifentrine; potential delays in enrolling patients, which could adversely affect our research and development efforts; we may not be successful in developing ensifentrine for multiple indications; our ability to obtain approval for and commercialize ensifentrine in multiple major pharmaceutical markets; misconduct or other improper activities by our employees, consultants, principal investigators, and third-party service providers; material differences between our “top-line” data and final data; our reliance on third parties, including clinical investigators, manufacturers and suppliers, and the risks related to these parties’ ability to successfully develop and commercialize ensifentrine; and lawsuits related to patents covering ensifentrine and the potential for our patents to be found invalid or unenforceable. These and other important factors under the caption “Risk Factors” in our Annual Report on Form 20-F filed with the Securities and Exchange Commission (“SEC”) on March 19, 2019, and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
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|Verona Pharma plc||Tel: +44 (0)20 3283 4200|
|Jan-Anders Karlsson, Chief Executive Officer |
Victoria Stewart, Director of Communications
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