Verona Pharma Strengthens its Clinical Team Ahead of Phase 3 Development of Ensifentrine

Nina Church joins as Executive Director of Global Clinical Development and Nancy Herje as Senior Director of Clinical Operations

 

LONDON, June 25, 2019 – 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®, Anoro®, Flovent®, Serevent® and Ventolin®. 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®. 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. Thes

e 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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