Verona Pharma plc Verona Pharma Granted Key Eu Patent Related To Late-stage Copd Clinical Candidate Ensifentrine

 
TIDMVRP 
 
 
   Bolsters patent estate for lead development candidate and provides 
expiry dates out to 2035 
 
   LONDON, April 09, 2019 (GLOBE NEWSWIRE) -- Verona Pharma plc (AIM:VRP) 
(Nasdaq: 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." 
 
   Patents 
 
   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(R) ), 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. 
 
   Forward-Looking Statements 
 
   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. 
 
 
 
 
For further information, please contact: 
Verona Pharma plc                                  Tel: [phone] 
Jan-Anders Karlsson, Chief Executive Officer       [e-mail] 
 Victoria Stewart, Director of Communications 
 
Stifel Nicolaus Europe Limited (Nominated Adviser  Tel: [phone] 
 and UK Broker) 
Stewart Wallace / Jonathan Senior / Ben Maddison 
 
FTI Consulting (UK Media and Investor enquiries)   Tel: [phone] 
Simon Conway / Natalie Garland-Collins             [e-mail] 
 
ICR, Inc. (US Media and Investor enquiries) 
Darcie Robinson                                    Tel: [phone] 
                                                    [e-mail] 
Stephanie Carrington                               Tel. [phone] 
                                                    [e-mail] 
 
 
 
 

(END) Dow Jones Newswires

April 09, 2019 02:00 ET (06:00 GMT)

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