Verona Pharma plc Verona Pharma Strengthens Its Clinical Team Ahead Of Phase 3 Development Of Ensifentrine
June 25 2019 - 2:00AM
UK Regulatory
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: +44 (0)20 3283 4200
Jan-Anders Karlsson, Chief Executive Officer info@veronapharma.com
Victoria Stewart, Director of Communications
N+1 Singer Tel: +44 (0)20 3283 4200
(Nominated Adviser and UK Broker)
Aubrey Powell / Jen Boorer / Iqra Amin (Corporate
Finance)
Mia Gardner (Corporate Broking)
Optimum Strategic Communications Tel: +44 (0)20 950 9144
(European Media and Investor Enquiries) verona@optimumcomms.com
Mary Clark / Anne Marieke Ezendam / Hollie Vile
Westwicke, an ICR Company Tel: +1 646-277-1282
(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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