Verona Pharma plc Verona Pharma Strengthens Its Clinical Team Ahead Of Phase 3 Development Of Ensifentrine

 
TIDMVRP 
 
 
   Nina Church joins as Executive Director of Global Clinical Development 
and Nancy Herje as Senior Director of Clinical Operations 
 
   LONDON, June 25, 2019 (GLOBE NEWSWIRE) -- Verona Pharma plc (AIM: VRP) 
(Nasdaq: VRNA) ("Verona Pharma"), a biopharmaceutical company focused on 
respiratory diseases, announces two senior appointments to its clinical 
team. They will lead the Phase 3 program for Verona Pharma's 
first-in-class product candidate, ensifentrine, for the maintenance 
treatment of chronic obstructive pulmonary disease ("COPD"). 
 
   Nina Church joins as Executive Director of Global Clinical Development 
and Nancy Herje as Senior Director of Clinical Operations. They 
strengthen Verona Pharma's clinical team led by Kathleen Rickard, MD, 
Chief Medical Officer, and will be based in the Company's US office. 
 
   "We are delighted to welcome Nancy and Nina to Verona Pharma," said 
Jan-Anders Karlsson, PhD, CEO of Verona Pharma. "They bring substantial 
expertise in respiratory drug development and a strong track record of 
planning and managing global clinical trial programs. We believe 
ensifentrine, with its unique mode of action and clinical profile, has a 
very attractive commercial potential. We plan to complete our Phase 2 
program with nebulized ensifentrine with data expected around year end 
and to enter pivotal Phase 3 trials in 2020." 
 
   Ms. Church brings 30 years of experience of late-stage clinical drug 
development in respiratory therapeutics, with 25 years at 
GlaxoSmithKline where she held a series of management positions, 
including Director, Global Operations COPD. At GlaxoSmithKline, Ms. 
Church was involved in the development of many respiratory therapeutics 
including Advair(R) , Anoro(R) , Flovent(R) , Serevent(R) and 
Ventolin(R) . She joins from Parion Sciences where she was Executive 
Director, Clinical Operations. 
 
   Ms. Herje has more than 25 years of experience in designing, planning 
and executing clinical programs for pharmaceutical and medical device 
companies including trials for the COPD therapeutic Flovent(R) . Prior 
to joining Verona Pharma, Nancy was a Senior Clinical Scientist at 
ExecuPharm and previously held roles at Chimerix, Aerocrine, Inspire and 
GlaxoSmithKline. 
 
   About COPD 
 
   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 
getting out of bed, showering, eating and walking. 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 
(LAMA/LABA +/- ICS) remain uncontrolled, experiencing symptoms that 
impair quality of life. These patients urgently need better treatments. 
 
   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. Verona 
Pharma's product candidate, ensifentrine (RPL554), is a first-in-class, 
inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 that 
has been shown to act as both a bronchodilator and an anti-inflammatory 
agent in a single compound. Nebulized ensifentrine is currently in Phase 
2b clinical development for the maintenance treatment of COPD and is 
planned to enter Phase 3 trials for this indication in 2020. Verona 
Pharma plans a targeted US launch of the nebulized formulation, which is 
expected to benefit from a simplified Medicare Part B reimbursement 
process in the US. Verona Pharma may also develop ensifentrine for the 
treatment of cystic fibrosis and asthma. 
 
   Ensifentrine has shown significant and clinically meaningful 
improvements in both lung function and COPD symptoms, including 
breathlessness, in prior Phase 2 clinical studies in patients with 
moderate-to-severe COPD. In addition, ensifentrine has further improved 
lung function and reduced lung volumes in patients taking standard 
short- and long-acting bronchodilator therapy, including maximum 
bronchodilator treatment with dual/triple therapy. Ensifentrine has been 
well tolerated in clinical trials involving more than 800 people to 
date. 
 
   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 Ms. Church's and Ms. 
Herje's roles at Verona Pharma, their potential contributions to the 
development of ensifentrine, the timing of Phase 3 trials of nebulized 
ensifentrine, the value of the COPD market, the potential of 
ensifentrine as a promising first-in-class treatment option for COPD and 
the availability of Medicare reimbursement. 
 
   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 and 
the completion of our Phase 2b trial; 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 
 
N+1 Singer                                         Tel: [phone] 
 (Nominated Adviser and UK Broker) 
Aubrey Powell / Jen Boorer / Iqra Amin (Corporate 
 Finance) 
Mia Gardner (Corporate Broking) 
 
Optimum Strategic Communications                   Tel: [phone] 
 (European Media and Investor Enquiries)            [e-mail] 
Mary Clark / Anne Marieke Ezendam / Hollie Vile 
 
Westwicke, an ICR Company                          Tel: [phone] 
 (US Investor enquiries) 
Stephanie Carrington                               Stephanie.carrington@icrinc 
                                                   .com 
 
 
 
 

(END) Dow Jones Newswires

June 25, 2019 02:00 ET (06:00 GMT)

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