Verona Pharma plc Verona Pharma Granted Key Eu Patent Related To Late-stage Copd Clinical Candidate Ensifentrine
April 09 2019 - 2:00AM
UK Regulatory
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: +44 (0)20 3283 4200
Jan-Anders Karlsson, Chief Executive Officer info@veronapharma.com
Victoria Stewart, Director of Communications
Stifel Nicolaus Europe Limited (Nominated Adviser Tel: +44 (0) 20 7710 7600
and UK Broker)
Stewart Wallace / Jonathan Senior / Ben Maddison
FTI Consulting (UK Media and Investor enquiries) Tel: +44 (0)20 3727 1000
Simon Conway / Natalie Garland-Collins veronapharma@fticonsulting.com
ICR, Inc. (US Media and Investor enquiries)
Darcie Robinson Tel: +1 203-919-7905
Darcie.Robinson@icrinc.com
Stephanie Carrington Tel. +1 646-277-1282
Stephanie.Carrington@icrinc.com
(END) Dow Jones Newswires
April 09, 2019 02:00 ET (06:00 GMT)
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